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  • Quality

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    Michael Parker at skills alliance is recruiting a QA Officer to specialise in GDP. I am working with one of the largest privately owned import and distribution companies in the UK. They are based in the West Midlands, just outside of Birmingham. They are looking for a several new roles in QA working across both GMP, GDP & QC. Over the pandemic their ability to be nimble has meant they have actually grown and have made several hires in QA this year.

    Overall Objective:
    Provision of QA support for the management and continual improvement of the company QMS, to ensure it meets the requirements of the company licences (including WDA(H)s and MIA), and the relevant parts of GDP and GMP at all times.
    Work effectively with other departments within the business as necessary, to ensure compliance with all relevant company and regulatory standards and maintain the safety, quality and efficacy of all products procured, handled, repackaged and supplied by the company.
    Support other members of the Quality department as necessary.


    Duties and Responsibilities:

    • Support maintenance and continual improvement of the company QMS by preparation, review, approval, training and implementation of SOPs and work instructions, as necessary.
    • Monitor changes in applicable GMP/GDP legislation and guidelines and support implementation of any necessary changes.
    • Identify compliance gaps and make recommendations for continuous improvement.
    • Manage own workload to ensure all tasks are completed within the timelines assigned to meet business needs and customer requirements.
    • Ensure the requirements of applicable product licences (e.g. PLPI, PLGB) are considered and adhered to as necessary.
    • Investigate and report quality incidents, utilising root cause analysis tools as necessary and applying an appropriate risk-based approach. Ensure all quality events and deviations are investigated to an appropriate level and are completed and reported in a timely manner.
    • Propose, implement, and monitor appropriate CAPA plans to address the root cause (or other causal/contributing factors) of non-conformances and ensure the effectiveness of all actions is monitored, as necessary.
    • Investigate and report complaints in a timely manner.
    • Prepare, co-ordinate and manage change controls.
    • Compile and review periodic product quality review reports.
    • Support product recalls where necessary.
    • Perform risk assessments.
    • Perform and report internal and external audits and housekeeping inspections, in accordance with the company audit schedules.
    • Support customer audits and regulatory inspections, as necessary.
    • Document control and archiving-adding new documents to Master Document List, ensure controlled documents are reviewed by periodic review date. Issuing controlled documents and reconcile superseded versions and archiving quality documents.
    • Review QMS documents (e.g. SOPs, work instructions, events, deviations, change controls etc.), ensuring all necessary requirements and standards are considered and approve as necessary.
    • Perform required checks to verify the authenticity of supplied products.
    • Prepare and deliver training, including preparation of training materials and competency assessments.
    • Perform and attend all necessary training and ensure a record of all training is maintained.
    • Perform qualification and/or quality audits and assessments to support approval of suppliers, customers, and service providers.
    • Monitor all suppliers, customers and service providers to ensure they are maintained in a qualified / approved status, taking into account any supply, service or other issues arising during routine use.
    • Generate and review Technical Agreements (TAs) with suppliers, customers and service providers.
    • Monitor the QMS and perform trend analysis. Propose and implement CAPA to address the outcomes from trend analysis as necessary, including potential process efficiency improvements.
    • Provide data, metrics and reports as necessary to monitor the suitability and effectiveness of the QMS. Attend and contribute to Quality Management Review (QMR) meetings. Generate minutes and actions of meetings when required.


    This is an urgent role so for full details please get in contact as soon as possible.


  • Quality

    negotionable
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    Michael Parker at Skills Alliance is currently recruiting several extremely exciting GCP auditor roles. My client are an exciting consultancy that have huge growth plans. The consultancy specialises in QA work solely across all areas of GxP.

    This role is to focus on their huge demand of GCP work their clients need, the clients range from small hyper growth Biotechs to large pharma.

    This is a great opportunity for someone with circa 5 years+ GCP auditing experience to broaden their experience and gain invaluable training and development. You will also get the opportunity to work with UK or global clients as well as get experience in other areas of GxP should you desire.

    The role will cover all areas of external auditing and be completely home based + travel. Below are some of the key responsibilities

    • Plan, conduct, report and follow up contracted audits within agreed budget and timelines
    • Conduct technical peer reviews and provide feedback on client deliverables
    • Assist with the preparation and facilitation of audits and regulatory inspections of clients, and work with responsible parties to prepare Corrective Action and Preventative Action (CAPA) plans as applicable
    • Provide strategic advice to clients on Quality Management System development and change
    • Provide a consultancy service for GCP and/or additional regulations
    • Develop and deliver training programs and/or materials
    • Manage the fulfillment of assigned contracted activities, identifying identify and escalate any potential out-of-scope activities
    • Keep relevant manager(s)/project manager, and the client where applicable, informed of the progress of all assigned contracted activities and any issues that may arise by providing regular updates and maintaining effective communication
    • Foster and maintain good, professional working relationships with clients and identify new business opportunities
    • Assist with the preparation of proposals and presentations to prospective clients

    Skills Required

    • Thorough knowledge of GCP and/or other applicable regulatory requirements
    • Excellent attention to detail, organisation, and prioritisation skills
    • Strong interpersonal skills, verbal and written skills, and the ability to communicate confidently at all levels
    • Self-motivation and ability to function independently and within a team
    • Ability to function calmly under pressure
    • Practical and enquiring approach to problem-solving
    • Dedication to quality and reliability in all aspects of work
    • Responsiveness to customer needs and focus on customer satisfaction

    This role is urgent so please get in touch as soon as possible if this is something you are interested in. Please note this role is only eligible for candidates based in the UK or eligible to work in the UK without sponsorship.

  • Quality

    Negotiable
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    Michael Parker at skills alliance is recruiting a Senior QC Operative. I am working with one of the largest privately owned import and distribution companies in the UK. They are based in the West Midlands, just outside of Birmingham. They are looking for a several new roles in QA working across both GMP, GDP & QC. Over the pandemic their ability to be nimble has meant they have actually grown and have made several hires in QA this year.

    Overall Objective:
    To be efficient in processing the work within the QC Department. Have a good knowledge of and always adhere to the company’s Standard Operating Procedures and comply with both Good Manufacturing Practice and Good Distribution Practice at all times. To comply with all company Health & Safety Policies, Procedures, Work Practices ensuring accuracy and quality and any other Health & Safety requirements at all times.
    __________________________________________________________________________________________
    Duties and Responsibilities:

    • Review and inspect incoming EU deliveries to verify the consignment has been received in an acceptable condition with no visible damages, indication of tampering, and that it is from an approved active supplier. The consignment was shipped securely under acceptable environmental conditions by an approved transport provider. Any products requiring special or secure storage requirements (temperature sensitive stock or controlled drugs) are processed in a timely manner and transferred to the appropriate location.
    • Record all relevant details of deliveries received on the company system.
    • Performing identity checks on raw product and reporting any discrepancies with the associated specification.
    • Ensuring all checks are recorded accurately during identification check.
    • Ensuring photographs of raw product are taken showing all faces (outer and inner) with batch number, expiry date and EU/ECMA visible and attached to batch documentation.
    • Ensuring all Italian sourced consignments undergo a Bollino authenticity check.
    • Ensuring all Greek sourced stock undergoes a Vignette authenticity check.
    • In process checks during production.
    • Performing a line clearance prior to and post QC final verification checks and completing the line clearance logbook accordingly.
    • Ensuring all relevant documentation is present with the working BPR and confirmed as complete.
    • Inspect materials or products being produced and recording outcomes in the relevant documentation.
    • Compering materials or products against a pre-defined standard specification.
    • Approving or rejecting components, packaging materials and finished products.
    • Ensure that if errors occurred, that they have been reported.
    • Check performs on the pre-printed packaging materials:
    • Removing and checking number of samples specified in the sampling plan for packaging material (number of samples is determined by QA personnel).
    • Escalating any quality defects to the QA who will assess the conformance or non-conformance of packaging material.
    • Performing identification check on the random sample that represents the batch; if any discrepancies related to the starting material or/and finished product found at this point, QC quarantines the whole unit.
    • Reviewing the batch records and ensuring all entries are inserted accurately.

    Support QC Manager:

    • Ensuring QC staff always comply with the applicable GMP requirements and associated processes and procedures.
    • Reporting any errors/non-compliances as quality incidents. Ensuring the details of any events or deviations raised are accurately recorded in the applicable controlled document (including the corresponding references).
    • Informing the operations manager of product related quality incidents as soon as possible.
    • Escalating any issues or concerns to The Quality Director, GMP QA Manager or RP.
    • Provide advice to staff regarding the quality standards.
    • Monitor operations to ensure compliance with quality standards.
    • Providing assistance to production staff where necessary regarding the quality standards.
    • Ensuring all retention samples are stored securely.
    • Ensuring all completed and signed batch records are stored securely.
    • Monitoring retention periods for batch documentation and retention samples.


    This is an urgent role so please get in touch as soon as possible if you are interested.

  • Clinical Development

    £65000 - £78000 per annum, Bonus + benefits + shares
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    Great opportunity for an experienced Study Manager or Senior Study Manager to join a niche Biotech working in advanced therapies. The role is permanent and the office is based in Central London (with flexibility).

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research and we have had great feedback from recent placements.

    The position is a wide ranging one given the size of the team. They need an autonomous Senior Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence would be preferable and global experience. It is a great opportunity to gain gene therapy/advanced therapies experience.

    This is a permanent and full-time role. The role would be home-based initially with travel to the Central London office. They offer an excellent salary – GBP 65,000-78,000 + bonus + benefits + shares.

    Skills Alliance are the exclusive partner for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Pre-Clinical

    £50000 - £65000 per annum, Excellent package
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    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    Skills Alliance are partnered to support a growing Biotech to hire for their Project Management team. The company are highly innovative and work in a new and exciting area in advanced therapies, they have some exciting partnerships established and are growing rapidly. It is a fanastic time to join and they have a great team in place.

    The role will support the PMO to deliver pre-clinical development projects and work closely with the R&D team. They are looking for someone at R&D PM level who has strong Pharma/Biotech experience ideally within pre-clinical – ideally MS Project experience and a PRINCE2 or similar PM qualification would be a plus too. This is a new role due to a lot of expansion.

    The role is permanent and full-time. they would like someone to go into the Oxford office when normality resumes (with flexibility to WFH 2-3 days). They will offer circa £50-65K depending on experience + bonus + benefits.

    Skills Alliance are the preferred partner to recruit this R&D Proejct Manager role. Please contact Mark Anderson for more info 0207 220 6209 or APPLY NOW.

  • Pre-Clinical

    £55000 - £65000 per annum, Excellent package
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    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    Skills Alliance are partnered to support a growing Biotech to hire for their Project Management / PMO team. The company work in a cutting edge area in the advanced therapies space and have won numerous awards recently for innovation, they are growing rapidly. It is a fantastic time to join and there will be great long-term opportunities.

    The role will support the PM group to deliver a range of interesting projects and it will work closely with Scientific teams. They are looking for someone at Senior R&D PM level who has strong Pharma/Biotech experience ideally in cell or gene therapy – ideally experience of Agile methodologies. This is a new role due to growth and expansion.

    The role is permanent and full-time. they would like someone to be based in their Cambridge office (with flexibility to WFH 2-3 days). They will offer circa £55-65K depending on experience + bonus + benefits.

    Skills Alliance are the preferred partner to recruit this Senior Project Manager role. Please contact Mark Anderson for more info 0207 220 6209 or APPLY NOW.

  • Clinical Operations

    $90000 - $140000 per annum, + bonus + excellent benefits
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    I am partnered exclusively with a World-class SME organisation at present to hire multiple Start-up roles – from Start-up Manager II to Associate Director level.

    The company is dedicated to developing their employees in the long term, meaning there is a good opportunity to expand scope of responsibility (including line management if desired). Candidates will be expected to have displayed a stable career background, they have very low turnover, we have had excellent feedback from recent placements, and they are a diverse and flexible employer.

    This role will be the primary point of contact for sponsors, also being involved in kick off/bid defence meetings, thus prior experience is required. The role will be very hand on with projects as opposed to providing just oversight, carrying the full workload of start-up of trials, handling on average 8 projects at any given time. Preferred therapy areas include oncology, cardiology, CNS and neurology but they are flexible, global experience also preferred. Experience levels can vary, looking for at least a couple years experience within an industry setting (ideally 4+ years in CRO). At level II & III there will be line management responsibilities, with AD/D level having additional managerial responsibilities.

    This position is remote contingent on a minimum of 4 years CRO experience, however it is preferred if candidates are more junior or close to their offices then some attendance would be ideal. They have offices in Cincinnati, Dallas and Texas. You can expect a salary of between $90-$140K + bonus + excellent benefits.

  • Clinical Operations

    $90000 - $125000 per annum
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    I am partnered with a World-class SME organisation at present to hire multiple Clinical Safety Manager roles – from Safety Manager II to Associate Director level.

    The company is dedicated to developing their employees in the long term, meaning there is a good opportunity to expand scope of responsibility (including line management if desired). Candidates will be expected to have displayed a stable career background, they have very low turnover, we have had excellent feedback from recent placements and they are a diverse and flexible employer.

    They are looking for an individual with several years of experience of clinical safety or pharmacovigilance within a CRO environment. The ideal candidate will currently be working under the same or closely aligned job title. Project management experience is preferred. Full proficiency within reviewing protocols and assessing all safety aspects of clinical trials. Weekly sponsor meetings to maintain clarity on on-going projects, ensuring set timelines are met.

    This position is remote for experienced candidates, however its is preferred if candidates are more junior or close to their offices then some attendance would be ideal. They have offices in Cincinnati, Dallas and Texas. Direct reports are dependent on seniority and WFH arrangements. You can expect a salary range between $90k-$125K + bonus with excellent benefits.

  • Quality

    €65000 - €75000 per annum, 13 Gehälter, Flexible Arbeitszeiten, Halb-Bezuschussung für ein ÖPNV-Ticket Raum Hamburg
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    Einer unserer Big Pharma Kunden sucht für seinen allerneusten Standort im wunderschönen Hamburg zum nächstmöglichen Zeitpunkt eine*n Qualifizierungsingenieur*in (m/w/d). Diese neue Herausforderung wirbt vor allem mit einem kompletten Neustart und großem Wachstumspotenzial, Möglichkeiten zur freien Entwicklung ohne festgefahrene Prozesse, einem neuen Gebäude und breite Möglichkeiten, sich selbst einzubringen.

    Ihr Aufgabengebiet:

    • Qualifizierung von Laborgeräten
    • Organisation und Erstellung von Qualifizierungsaktivitäten gemäß cGMP-Regularien für individuelle Projekte
    • Aufsetzung von Qualifizierungsdokumenten (DQ, IQ, OQ, PQ) gemäß aktuellen Regularien und SOPs
    • Aktivitäten rund um Testpläne und Berichte für Neugeräte
    • Cross-funktionale Zusammenarbeit mit anderen Abteilungen
    • Koordination und Kommunikation mit Fremdfirmen
    • Erstellung und Aktualisierung von SOPs und anderen Vorgabedokumenten
    • Ggfs. Prozessvalidierung
    • Ggfs. Computer System Validierung

    Interessante Tätigkeiten? Das sollten Sie mitbringen:

    • Ein abgeschlossenes Studium in (vorzugsweise) einem ingenieurwissenschaftlichem Studium oder einer anderen naturwissenschaftlichen Disziplin
    • Berufserfahrung in der Pharmaindustrie und bestenfalls der Qualifizierung von Laborgeräten
    • Kenntnis in den GMP-Anforderungen für den Pharmabereich sowie in den dazugehörigen Regularien (ICH, EG GMP, FDA) wünschenswert
    • Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift

    Neugierig auf diese neue Herausforderung? Lust, bei einem Big Player von Anfang an mit dabei zu sein?
    Bewerben Sie sich gerne oder kontaktieren Sie Fritz Köster für weitere Informationen und Rückfragen!

    fritz.koester@skillsalliance.com
    +49 69 50 955 654
    https://www.linkedin.com/in/fritzkoester/

  • Apply

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    Bereit für eine neue Herausforderung?

    Derzeit sucht ein Kunde mit Sitz im Hamburg einen Quality Control Associate (m/w/d) im Bereich Bioanalytik.
    Das mittelständige Unternehmen besteht bereits seit knapp über 20 Jahren und gilt als weltweit führender Anbieter von Biotechnologien.

    Das sind Ihre Aufgaben:

    • Entwicklung, Implemetierung und Validierung von Analysenmethoden für Nukleinsäuren (mRNA)
    • Planung und Prüfung von Analysemethoden
    • Anleitung und Betreuung von Labormitarbeitern
    • Mitgestaltung der Kontrollstrategie und enger Austausch mit verschiedenen Fachbereichen
    • Bearbeitung von Abweichungen, Change Control-Anträgen, CAPA-Maßnahmen, sowie OOX-Ergebnissen
    • Planung, Koordination und Auswertung analytischer Technologie-Transferaktivitäten
    • Betreuung von externen Analyselaboren

    Das bringen Sie mit:

    • Naturwissenschaftliches Studium, idealerweise Promotion in Biochemie, Biotechnologie oder ähnlicher Studienrichtung
    • 2-3 Jahre Industrieerfahrung in der Qualitätskontrolle
    • Sie haben Erfahrung in Bezug auf molekularbiologische Methoden (ELISA, kaplillarelektophoretische Methoden, Gehaltsmethoden, Gelelektrophoretishce Methoden, qPCR, Massenspektronomie, Arzneibuchmethoden)
    • Sehr gute Englisch- und Deutschkenntnisse in Wort und Schrift
    • Eine selbstständige, zuverlässige und präzise Arbeitsweise zeichnet Sie aus
    • Offene und kommunikative Persönlichkeit
    • Sie bringen die Fähigkeit zur Koordination von Arbeitsabläufen mit und berücksichtigen dabei übergreifende Zusammenhänge
    • Teamfähigkeit und Freude am Erfolg zeichnet sie aus

    Falls Ihr Interesse geweckt wurde, kontaktieren Sie Luis Freitag unter luis.freitag@skillsalliance.com oder telefonisch unter +496950955657.

  • Quality

    €35000 - €45000 per annum, 38,5 Stunden, Flexible Arbeitszeiten, Job-Ticket, 13 Gehälter
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    Unser großer Big Pharma Kunde sucht für seinen neuen Standort in Hamburg eine*n Labortechniker*in in der Qualitätssicherung.

    Ihre Aufgaben:

    • Biochemischer und physikalischer Analytik von Rohstoffen, Hilfsstoffen und APIs im Zusammenhang der mRNA-Herstellung
    • Begleitung der Musterzüge von Rohmaterialien und weiteren chemischen Hilfsstoffen
    • Sicherstellung einer GMP-gerechten Dokumentation
    • Assistenz in der Methodenvalidierung durch Zusammenarbeit mit fachlichen Experten
    • Optimierung von Analysemethoden in Zusammenarbeit mit den Fachabteilungen
    • Handling von Rückstellmustern, Kontrolle von GMP Dokumentationen, Bearbeitung von OOX Untersuchungen und Abweichungen
    • Erstellung von Prüfmethoden, SOP’s und Bedienungsanleitungen


    Ihr Profil:

    • Abgeschlossene Berufsausbildung als Chemielaborant, CTA, Biologielaborant, BTA, PTA oder vergleichbar
    • Berufserfahrung im GMP-regulierten Umfeld sowie Kenntnisse und Erfahrungen in der (bio)chemischen Analytik von Arzneimitteln oder artverwandten Stoffen
    • Möglichst Kenntnisse und Erfahrungen in den analytischen Methoden der Photometrie, Kapillarelektrophorese (CE), Arzneibuch Methoden (Ph. Eur.)
    • Sehr gute Deutschkenntnisse in Wort und Schrift sowie möglichst Englischkenntnisse gut in Wort und Schrift

    Erkennen Sie sich wieder?
    Senden Sie gerne Ihre Bewerbung oder Ihre Rückfragen an:

    Fritz Köster
    fritz.koester@skillsalliance.com
    +49 69 955 654

  • Medical Devices

    Competitive
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    Sind Sie bereit für den nächsten Karriereschritt?

    Derzeit suchen wir für einen Kunden im Raum Stuttgart zum nächstmöglichen Zeitpunkt einen Design Control Manager (m/w/d). Das mittelständige Unternehmen ist führender Hersteller von aktiven Medizinprodukten, ist mit mehreren Standorten im In- und Ausland vertreten und befindet sich momentan auf Wachstumskurs.

    Das sind Ihre Aufgaben:

    • QA-Ansprechpartner des Entwicklungsteams für aktive Medizinprodukte
    • Sicherstellung der Einhaltung gesetzlicher und normativer Vorschriften während der Produktentwicklung und des Lebenszyklusmanagements
    • Unterstützung bei technischen und qualitätsrelevanten Themen an den Produktionsstandorten
    • Überprüfung von Teststrategien, Testplänen und Testberichten, einschließlich Stabilitätstests und Infrastrukturqualifizierung
    • Erstellung, Überprüfung und Genehmigung der Entwicklungs-/DHF-Dokumentation und Unterstützung der Zulassungsabteilung bei Zulassungsanträgen
    • Kundenkommunikation zu qualitätsrelevanten Themen

    Das bringen Sie mit:

    • Abgeschlossenes technisches Studium, idealerweise im Bereich (Bio-)Medizintechnik
    • Mehrjährige Erfahrung in Entwicklungs-/Lebenszyklusprojekten von aktiven Medizinprodukten oder ähnlichen Produkten in der Medizintechnik oder Pharmaindustrie
    • Fundierte Kenntnisse der einschlägigen Normen und Vorschriften, sowohl für Medizinprodukte als auch für GMP, insbesondere ISO 13485, 21 CFR 210/211, 820 und der EU-GMP-Richtlinien
    • Technische, soziale und methodische Kompetenz, verbunden mit einer Hands-on-Mentalität
    • Präzise und sachorientierte Kommunikation
    • Sehr gute Kenntnisse der deutschen und englischen Sprache in Wort und Schrift

    Falls Ihr Interesse geweckt wurde, kontaktieren Sie Luis Freitag unter luis.freitag@skillsalliance.com oder telefonisch unter +496950955657.

  • Clinical Operations

    £80000 - £95000 per annum, Excellent package
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    Senior Clin Ops role with an Oncology focussed Biopharma in London. Working at program level and leading their leading programs and line managing a small team.

    This is a rare opportunity to join a reputable Biopharmaceutical company with a great reputation, they have a great pipeline spanning phase I-III and trials being run globally. They are growing and will offer excellent long-term opportunities. We have had excellent feedback from recent placements.

    They are recruiting for a Clinical Program Manager / AD role due to growth and new studies coming up, you would be leading their high profile programs in Oncology and they need a vastly experienced individual, with Oncology trial management and line management experience. They want someone who can work at a senior level and take on a leadership role in the team. It could be haematology or solid tumours.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in London. They will offer an excellent salary and package – around £80-905K basic salary + bonus + benefits + stock.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Medical Devices

    €75000 - €85000 per annum, Flexible Arbeitszeiten, Fahrtkostenzuschuss, Kindergartenzuschuss, Betr. Altersvorsorge, individuell leistungsgerechte Gehaltsen
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    Unser Kunde, ein mittelständisches Familienunternehmen im wunderschönen Norden Deutschlands sucht einen Manager in Sachen Sterilisation. Der Kunde ist ein etablierter und führender Anbieter von Medizinprodukten und führt seit mehr als 50 Jahren Innovationen in seinem Bereich an. Sein umfangreiches Produktportfolio ermöglicht Exporte in bereits mehr als 50 Ländern und ist somit international bekannt.

    Als Manager*in in der Sterilisation wäre dies ihr Aufgabengebiet:

    • Erstellung von Plänen und zugehörigen Berichten zur Biologischen Sicherheit gemäß ISO 10993-1
    • Koordination von Biokompatibilitätsprüfungen und Kommunikation mit externen Prüflaboren
    • Auswertung und Dokumentation von Prüfberichten
    • Planung, Durchführung und Überwachung von Sterilisationsvalidierungen (vorzugsweise Ethylenoxid sowie Gamma-Sterilisationsverfahren)
    • Kommunikation mit externen Sterilisationsdienstleistern sowie Koordination von entsprechenden Verfahrensabläufen
    • Bewertung von Validierungsberichten (insbesondere Verpackung und Sterilisation)
    • Screening, Bereitstellung und Umsetzung von relevanten Normenanforderungen unter Berücksichtigung des Stands der Technik
    • Erstellung relevanter Kapitel der Technischen Dokumentation gemäß Verordnung (EU) 2017/745
    • Kommunikation mit Lieferanten, Projektpartnern und Anwendern (national/ international)

    Für diese Stelle müssten Sie dieses Profil mitbringen:

    • Abgeschlossenes Studium (Chemie / Toxikologie, Biologie oder vergleichbar)
    • Fachkenntnis für Ethylenoxid sowie Gamma-Sterilisationsverfahren
    • Erfahrung in den Bereichen Biokompatibilität und Sterilisation
    • Kenntnisse von den entsprechenden einschlägigen Standards (ISO 10993, ISO 11135, ISO 11137, ISO 116076, REACH, RoHS)
    • Kenntnisse in den normativen und regulatorischen Anforderungen an Medizinprodukte (ISO 13485:2016, Richtlinie 93/42/EWG und Verordnung (EU) 2017/745
    • Selbstständige, strukturierte und zielorientierte Arbeitsweise
    • Engagement und Leistungsbereitschaft
    • Bereitschaft zu abteilungsübergreifendem Arbeiten
    • Sehr gute Englischkenntnisse in Wort und Schrift

    Erkennen Sie sich mit Ihren Stärken wieder? Bewerben Sie sich gerne! Bei Rückfragen melden Sie sich gerne per Mail an

    fritz.koester@skillsalliance.com.
    +49 69 50 955 654

    Ich freue mich auf Ihre Mail / Ihren Anruf / Ihre Bewerbung!

  • Medical Devices

    €60000 - €80000 per annum, Attraktive Sozialleistungen
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    Unser Kunde im schönen Unterfranken sucht nach Verstärkung in seinem Regulatory Affairs Team! Ein geeigneter Kandidat sollte in jedem Fall Erfahrung in der Arbeit mit aktiven und sterilen Medizinprodukten und/oder Software mitbringen. Lesen Sie unten weiter, ob die Stelle Ihr Interesse weckt und auf Ihre Kenntnisse passt:

    Ihr Tätigkeitsbereich

    • Verantwortung für internationale Registrierungs- und Re-Registrierungsprojekte für aktive und sterile Medizinprodukte
    • Planung und Durchführung von komplexen internationalen Zulassungsprojekten mit unseren lokalen Partnern / Distributoren
    • Mitwirkung an der Entwicklung von internationalen Zulassungsstrategien für aktive Medizinprodukte und Koordination mit dem F&E-Team
    • Mitwirkung an Änderungsanträgen zu zulassungsrelevanten Themen und Überprüfung normativer und regulatorischer Anforderungen (auch international)
    • Überprüfung interner Dokumente (z. B. Etikettierung, Werbematerialien, Schulungsunterlagen)
    • Kontinuierliche Unterstützung der Projektteams in regulatorischen Fragen, insbesondere auch während der Entwicklungsphase
    • Überprüfung von Änderungen im regulatorischen Umfeld und Mitteilung relevanter Änderungen an das Unternehmen, um eine kontinuierliche Einhaltung zu gewährleisten
    • Erstellung von Verfahren und internen Standards nach Bedarf (z. B. SOPs, Arbeitsanweisungen, Formulare und Checklisten)

    Ihr Profil

    • Abgeschlossenes Studium der im (Medizin-)technischen Bereich oder einer verwandten Disziplin
    • Mindestens 3-5 Jahre einschlägige Berufserfahrung
    • Erfahrung in der Zertifizierung und internationalen Registrierung von aktiven oder sterilen Medizinprodukten und in der Erstellung von Zulassungsdossiers
    • Erfahrung in der Entwicklung aktiver Medizinprodukte oder Software-Entwicklung
    • Kenntnisse der EU-, US- und weltweiten Vorschriften für Medizinprodukte
    • Kenntnisse der einschlägigen Normen und zugehörigen Prüfverfahren wie IEC 60601-1, IEC 60601-2-22, IEC 60601-1-2, IEC 60601-1-6, IEC 60825, IEC 62304 sowie der entsprechenden Spezifikationen für sterile Medizinprodukte
    • Erfahrung in der Arbeit in multidisziplinären und internationalen Projektteams

    Soweit nach Ihrem Geschmack? Rückfragen können Sie gerne an Fritz Köster stellen:

    fritz.koester@skillsalliance.com | +49 69 50 955 654

    Wir freuen uns auf Ihre Bewerbung!

  • CMC

    90000€ - 110000€
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    Regulatory Affairs Abteilung in Big Pharma sucht Zuwachs!

    Unser Kunde, einer der Top 10 Big Players in Pharma, sucht nach einem*r neuen Regulatory Affairs Manager*in an seinem Standort in Süddeutschland. Bringen Sie Erfahrung in Sachen Zulassung, Audits, CMC, PV und Drug Safety mit? Dann freuen wir uns auf Ihre Bewerbung!

    Weitere Aufgabengebiete sind unter anderem:

    • Aufgaben eines*r Informationsbeauftragten in Berücksichtigung von §74a des AMG
    • Durchführung von Audits
    • Aufbereitung und Pflege bereits ausgearbeiteter Zulassungen
    • Dossierpflege
    • Zusammenarbeit mit PV und Drug Safety
    • Hauptverantwortung für die Vereinbarung nationaler wissenschaftlicher Gutachten mit den zuständigen nationalen Behörden
    • Zusammenarbeit mit den europäischen Gruppen für RA und Unternehmen in regulatorischen Fragen
    • Enge Zusammenarbeit mit der Supply Chain, um etwaige Rückstände bei den auf dem Markt befindlichen Produkten zu erkennen

    Diese weiteren Qualitäten sollten Sie für diese Stelle mitbringen:

    • Erfolgreich abgeschlossenes Studium der Pharmazie oder einer anderen relevanten Naturwissenschaft
    • Langjährige Erfahrung in der Arzneimittelzulassung
    • Erfahrung in der Industrie
    • Qualifizierte*r Informationsbeauftragte*r nach §74a AMG
    • Sehr gutes Verständnis der nationalen und internationalen europäischen Arzneimittelregularien
    • Englische Sprache sehr gut in Wort und Schrift, Deutsche Sprache bestenfalls muttersprachlich oder sehr gut in Wort und Schrift

    Erkennen Sie sich in dieser Beschreibung wieder? Bewerben Sie sich!

  • HR and talent acquisition

    £55000 - £65000 per annum
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    A people centric CRO is seeking a Senior Talent Acquisition Partner to join their small but rapidly growing team.
    The Recruitment Specialist will be an integral part of the organisation and will partner closely with hiring manager to drive growth across the UK and Europe.

    Responsibilities:

    • Design and execute recruitment strategies
    • Partner closely with hiring managers throughout the recruitment cycle
    • Determine appropriate compensation and facilitate final packages and employment contracts
    • Long term talent pipelining
    • Candidate attraction through networking and advertising

    Experience:

    • Bachelor’s Degree or equivalent
    • Well experienced in Pharmaceuticals / Life Sciences recruitment
    • Thrives in a fast-paced environment, autonomous working environment

    Please contact Sarah Brambill from Skills Alliance to find out more!

  • HR and talent acquisition

    £70000 - £80000 per annum
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    A people centred CRO is seeking a HR Business Partner to join them for a period of exciting change.

    The Human Resources BP will have the opportunity to work in close collaboration with business leaders across Europe, offering solutions to optimise employee and business performance.

    Responsibilities:

    • Develop strong partnerships with business leaders across Europe
    • Change management projects
    • Drive performance culture
    • EU employee relations
    • Line management of HR generalists
    • Drive employee engagement
    • Lead Diversity and Inclusion initiative
    • Employee wellbeing and engagement initiatives
    • Design and execute new HR initiatives, policies and best practices


    Requirements:

    • CIPD or equivalent
    • Excellent communication and coaching skills
    • Experienced in challenging and directing senior stakeholders
    • Strategic problem solver


    Please contact Sarah Brambill from Skills Alliance for more information!

  • Quality

    €65000 - €75000 per annum, 13 Gehälter, Flexible Arbeitszeiten, Halb-Bezuschussung für ein ÖPNV-Ticket Raum Hamburg
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    Einer unserer Big Pharma Kunden sucht für seinen allerneusten Standort im wunderschönen Hamburg zum nächstmöglichen Zeitpunkt eine*n Qualifizierungsingenieur*in (m/w/d). Diese neue Herausforderung wirbt vor allem mit einem kompletten Neustart und großem Wachstumspotenzial, Möglichkeiten zur freien Entwicklung ohne festgefahrene Prozesse, einem neuen Gebäude und breite Möglichkeiten, sich selbst einzubringen.

    Ihr Aufgabengebiet:

    • Qualifizierung von Laborgeräten
    • Organisation und Erstellung von Qualifizierungsaktivitäten gemäß cGMP-Regularien für individuelle Projekte
    • Aufsetzung von Qualifizierungsdokumenten (DQ, IQ, OQ, PQ) gemäß aktuellen Regularien und SOPs
    • Aktivitäten rund um Testpläne und Berichte für Neugeräte
    • Cross-funktionale Zusammenarbeit mit anderen Abteilungen
    • Koordination und Kommunikation mit Fremdfirmen
    • Erstellung und Aktualisierung von SOPs und anderen Vorgabedokumenten
    • Ggfs. Prozessvalidierung
    • Ggfs. Computer System Validierung

    Interessante Tätigkeiten? Das sollten Sie mitbringen:

    • Ein abgeschlossenes Studium in (vorzugsweise) einem ingenieurwissenschaftlichem Studium oder einer anderen naturwissenschaftlichen Disziplin
    • Berufserfahrung in der Pharmaindustrie und bestenfalls der Qualifizierung von Laborgeräten
    • Kenntnis in den GMP-Anforderungen für den Pharmabereich sowie in den dazugehörigen Regularien (ICH, EG GMP, FDA) wünschenswert
    • Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift

    Neugierig auf diese neue Herausforderung? Lust, bei einem Big Player von Anfang an mit dabei zu sein?
    Bewerben Sie sich gerne oder kontaktieren Sie Fritz Köster für weitere Informationen und Rückfragen!

    fritz.koester@skillsalliance.com
    +49 69 50 955 654
    https://www.linkedin.com/in/fritzkoester/

  • Clinical Development

    £65000 - £78000 per annum, Bonus + benefits + shares
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    Great opportunity for an experienced Study Manager or Senior Study Manager to join a niche Biotech working in advanced therapies. The role is permanent and the office is based in Central London (with flexibility).

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research and we have had great feedback from recent placements.

    The position is a wide ranging one given the size of the team. They need an autonomous Senior Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence would be preferable and global experience. It is a great opportunity to gain gene therapy/advanced therapies experience.

    This is a permanent and full-time role. The role would be home-based initially with travel to the Central London office. They offer an excellent salary – GBP 65,000-78,000 + bonus + benefits + shares.

    Skills Alliance are the exclusive partner for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • Clinical Development

    £60000 - £80000 per annum, Bonus + benefits
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    *PHARMA/CRO EXPERIENCE REQUIRED*

    A great opportunity to join a medium-sized CRO with a great culture and low turnover. They are recruiting for PM and Senior PM roles due to organic growth and new studies.

    This company have a great track record and have been very successful during COVID where other CROs have struggled. They are a SME CRO who are dynamic and work in very interesting and complex therapy areas. Studies span phases I-IV and they work in Oncology and Gene Therapy amongst other areas.

    They are recruiting for multiple roles due to new studies coming in and they need an experienced cross-functional PM who has budget management experience. It could be working on a range of studies and would be working globally. There are also opportunities to progress quickly.

    This is a permanent and full-time role. They have an office in the South East but everyone is now home-based and this can be a remote role across the UK. They will offer a very good salary – GBP 60-80K + bonus + benefits.

    Skills Alliance are the preferred supplier for this new Senior CPM / CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Development

    £65000 - £80000 per annum, Bonus + benefits
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    *PHARMA/CRO EXPERIENCE REQUIRED*

    Rare and exclusive opportunity to join a small CRO, it is a Senior Project Manager role which can be home-based across the UK.

    This small organisation are well established and have a global presence with offices in Europe and the US. They have a friendly and family feel to the organisation and offer excellent flexibility and work life balance. This CRO has a strong reputation in the market and are well known in the niche that they work in. We have had great feedback from recent placements.

    The Senior Project Manager will be responsible for managing a full-service global trial in Neurodegeneration – they also have studies coming up in Oncology. They need a strong Senior PM candidate with CRO experience, EU trial management, phase II and III and budget management are essential. Experience of bid defenses and in Neuroscience are preferred. In return, the individual will be well rewarded with excellent flexibility and a strong package.

    This is a permanent and full-time role. They have an office in the South East but everyone is now home-based and this can be a remote role across the UK. They will offer a very good salary around £65-80K depending on experience + bonus + benefits.

    Skills Alliance are the exclusive partner for this new Senior PM / CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £65000 - £75000 per annum, Excellent package
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    Senior Global Clinical Study Manager position – purely working in Oncology, could be solid tumours, haematology or advanced therapies. Study responsibility and line management of a small team.

    This is a great opportunity to join a World-class Biopharmaceutical company with a strong reputation, they have a wide-ranging pipeline spanning phase I-III (and late phase) and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in Oncology at present and we have had excellent feedback from recent placements.

    They are recruiting for a Senior Clinical Study Manager / Senior Global Trial Manager role due to growth and new studies coming up, you would be leading their high profile programs in Oncology and they need a an experienced individual, with Oncology trial management and ideally line management experience. They want someone who can work at a senior level and take on a leadership role in the team. It could be or solid tumours, haematology or in their cell & gene therapy team.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in London. They will offer an excellent salary and package – around £65-75K basic salary + excellent bonus + benefits + stock.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Clinical Operations

    £55000 - £70000 per annum, Excellent package
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    Clinical Study Manager position – purely working in Oncology, could be solid tumours, haematology or advanced therapies.

    This is a great opportunity to join a World-class Biopharmaceutical company with a strong reputation, they have a wide-ranging pipeline spanning phase I-III (and late phase) and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in Oncology at present and we have had excellent feedback from recent placements.

    They are recruiting for a Clinical Study Manager / Clinical Trial Manager role due to growth and new studies coming up, you would be managing their high profile programs in Oncology and they need a an experienced individual, with Oncology trial management. It could be or solid tumours, haematology or in their cell & gene therapy team.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in London. They will offer an excellent salary and package – around £55-70K basic salary + excellent bonus + benefits.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Clinical Operations

    £55000 - £70000 per annum, Excellent package
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    Clinical Study Manager position – purely working in their Infectious Disease/Virology team.

    This is a great opportunity to join a World-class Biopharmaceutical company with a strong reputation, they have a wide-ranging pipeline spanning phase I-III (and late phase) and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in growth at present and we have had excelletn feedback from previous placements.

    They are recruiting for a Clinical Study Manager / Clinical Trial Manager role due to growth and new studies coming up, they will offer excellent progression opportunities, with rapid promotion prospects possible for high performing individuals. You would be managing their high profile programs in Virology and they need a an experienced individual, with EU trial management, ideally in phase II and III.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in London. They will offer an excellent salary and package – around £55-70K basic salary + excellent bonus + benefits.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Clinical Operations

    £55000 - £70000 per annum, Excellent package
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    Clinical Study Manager position – purely working in their Inflammation team.

    This is a great opportunity to join a World-class Biopharmaceutical company with a strong reputation, they have a wide-ranging pipeline spanning phase I-III (and late phase) and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in growth at present and we have had excellent feedback from previous placements.

    They are recruiting for a Clinical Study Manager / Clinical Trial Manager role due to growth and new studies coming up, they will offer excellent progression opportunities, with rapid promotion prospects possible for high performing individuals. You would be managing their high profile programs in Inflammation and they need a an experienced individual, with EU trial management, ideally in phase II and III.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in London. They will offer an excellent salary and package – around £55-70K basic salary + excellent bonus + benefits.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Clinical Operations

    £55000 - £70000 per annum, Excellent package
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    Clinical Study Manager position – purely working in their Infectious Disease/Virology team.

    This is a great opportunity to join a World-class Biopharmaceutical company with a strong reputation, they have a wide-ranging pipeline spanning phase I-III (and late phase) and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in growth at present and we have had excellent feedback from previous placements.

    They are recruiting for a Clinical Study Manager / Clinical Trial Manager role due to growth and new studies coming up, they will offer excellent progression opportunities, with rapid promotion prospects possible for high performing individuals. You would be managing their high profile programs in Virology and they need a an experienced individual, with EU trial management, ideally in phase II and III.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in London. They will offer an excellent salary and package – around £55-70K basic salary + excellent bonus + benefits.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Pre-Clinical

    £55000 - £65000 per annum, Excellent package
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    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    Skills Alliance are partnered to support a growing Biotech to hire for their Project Management / PMO team. The company work in a cutting edge area in the advanced therapies space and have won numerous awards recently for innovation, they are growing rapidly. It is a fantastic time to join and there will be great long-term opportunities.

    The role will support the PM group to deliver a range of interesting projects and it will work closely with Scientific teams. They are looking for someone at R&D PM level who has strong Pharma/Biotech experience ideally in stem cells or gene therapy – ideally experience of Agile methodologies. This is a new role due to growth and expansion.

    The role is permanent and full-time. they would like someone to be based in their Cambridge office (with flexibility to WFH 2-3 days). They will offer circa £55-65K depending on experience + bonus + benefits.

    Skills Alliance are the preferred partner to recruit this Senior Project Manager role. Please contact Mark Anderson for more info 0207 220 6209 or APPLY NOW.

  • Pre-Clinical

    £50000 - £65000 per annum, Excellent package
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    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    Skills Alliance are partnered to support a growing Biotech to hire for their Project Management team. The company are highly innovative and work in a new and exciting area in advanced therapies, they have some exciting partnerships established and are growing rapidly. It is a fanastic time to join and they have a great team in place and is working at the cutting edge of advanced therapies.

    The role will support the PMO to deliver pre-clinical development projects and work closely with the R&D team. They are looking for someone at R&D PM level who has strong Pharma/Biotech experience ideally within pre-clinical – ideally MS Project experience and a PRINCE2 or similar PM qualification would be a plus too. This is a new role due to growth and expansion.

    The role is permanent and full-time. they would like someone to go into the Oxford office when normality resumes (with flexibility to WFH 2-3 days). They will offer circa £50-65K depending on experience + bonus + benefits.

    Skills Alliance are the preferred partner to recruit this R&D Proejct Manager role. Please contact Mark Anderson for more info 0207 220 6209 or APPLY NOW.

  • Project Management

    £65000 - £75000 per annum, Excellent package
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    Skills Alliance are retained on a unique opportunity with an innovative vaccine organisation. They are hiring for multiple PMs due to increased investment and expansion.

    The organisation specialises in vaccine development, partnering with Pharmas and Biotechs to combat epidemic outbreaks such as COVID and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference. They are very well funded and are an employer who is very focused on diversity.

    The Senior Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous cross-functional project management experience, ideally managing projects from phase I-III. They will consider experienced PMs from Pharma, Biotech or CRO and vaccines experience would be a strong preference. The feedback from recent placements has been outstanding.

    This is a full-time and permanent position to be home-based with infrequent travel to their offices in Central London when normality resumes. They will offer a very competitive salary – circa £65-£75K depending on experience + full benefits package.

    Skills Alliance are the exclusive partner for this role, please get in contact with Mark Anderson for more details – +44 207 220 6209.

  • Project Management

    £40000 - £50000 per annum, Excellent package
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    Skills Alliance are retained on a unique opportunity with an innovative vaccine organisation. They are hiring for multiple Project Coordinators due to increased investment and expansion.

    The organisation specialises in vaccine development, partnering with Pharmas and Biotechs to combat epidemic outbreaks such as COVID and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference. They are very well funded and are an employer who is very focused on diversity.

    The Project Coordinator will support the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible for supporting the PMs with the opportunity to progress into a PM role in the long-term. They require previous CTA or Project Coordination experience. They will consider experienced candidates from Pharma, Biotech or CRO. The feedback from recent placements has been outstanding.

    This is a full-time and permanent position to be home-based with some travel to their offices in Central London when normality resumes. They will offer a very competitive salary – circa £40-50K depending on experience + full benefits package.

    Skills Alliance are the exclusive partner for this role, please get in contact with Mark Anderson for more details – +44 207 220 6209.

  • Project Management

    £60000 - £75000 per annum, Excellent package
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    Skills Alliance are retained on a unique opportunity with an innovative vaccine organisation. They are hiring for multiple PMs due to increased investment and expansion.

    The organisation specialises in vaccine development, partnering with Pharmas and Biotechs to combat epidemic outbreaks such as COVID and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference. They are very well funded and are an employer who is very focused on diversity.

    The Senior Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous cross-functional project management experience, ideally managing projects from phase I-III. They will consider experienced PMs from Pharma, Biotech or CRO and vaccines experience would be a strong preference. The feedback from recent placements has been outstanding.

    This is a full-time and permanent position to be home-based with infrequent travel to their offices in Central London when normality resumes. They will offer a very competitive salary – circa £60-£75K depending on experience + full benefits package.

    Skills Alliance are the exclusive partner for this role, please get in contact with Mark Anderson for more details – +44 207 220 6209.

  • Pre-Clinical

    £55000 - £65000 per annum, Excellent package
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    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    Skills Alliance are partnered to support a growing Biotech to hire for their Project Management / PMO team. The company work in a cutting edge area in the advanced therapies space and have won numerous awards recently for innovation, they are growing rapidly. It is a fantastic time to join and there will be great long-term opportunities.

    The role will support the PM group to deliver a range of interesting projects and it will work closely with Scientific teams. They are looking for someone at Senior R&D PM level who has strong Pharma/Biotech experience ideally in cell or gene therapy – ideally experience of Agile methodologies. This is a new role due to growth and expansion.

    The role is permanent and full-time. they would like someone to be based in their Cambridge office (with flexibility to WFH 2-3 days). They will offer circa £55-65K depending on experience + bonus + benefits.

    Skills Alliance are the preferred partner to recruit this Senior Project Manager role. Please contact Mark Anderson for more info 0207 220 6209 or APPLY NOW.

  • Clinical Operations

    $90000 - $140000 per annum, + bonus + excellent benefits
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    I am partnered exclusively with a World-class SME organisation at present to hire multiple Start-up roles – from Start-up Manager II to Associate Director level.

    The company is dedicated to developing their employees in the long term, meaning there is a good opportunity to expand scope of responsibility (including line management if desired). Candidates will be expected to have displayed a stable career background, they have very low turnover, we have had excellent feedback from recent placements, and they are a diverse and flexible employer.

    This role will be the primary point of contact for sponsors, also being involved in kick off/bid defence meetings, thus prior experience is required. The role will be very hand on with projects as opposed to providing just oversight, carrying the full workload of start-up of trials, handling on average 8 projects at any given time. Preferred therapy areas include oncology, cardiology, CNS and neurology but they are flexible, global experience also preferred. Experience levels can vary, looking for at least a couple years experience within an industry setting (ideally 4+ years in CRO). At level II & III there will be line management responsibilities, with AD/D level having additional managerial responsibilities.

    This position is remote contingent on a minimum of 4 years CRO experience, however it is preferred if candidates are more junior or close to their offices then some attendance would be ideal. They have offices in Cincinnati, Dallas and Texas. You can expect a salary of between $90-$140K + bonus + excellent benefits.

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    Great opportunity for an independent Senior Trial Manager (or AD) with strong Oncology experience. This is working in a very exciting and growing European based Biotech who have a great Immuno-Oncology pipeline and have had excellent feedback from the FDA. Need to be able to work in small Biotech environment and work autonomously. Basket studies and protocol writing experience would be a bonus. This is a great opportunity to work on innovative immuno-oncology studies, working in a team of around 35 highly experienced, high performing individuals. They have been very successful in securing over $170m in funding since their inception.

    This is a remote position working, requiring the candidate to be located in the East Coast, with an office location currently being set-up. It will report directly into the VP. You can expect a salary between $130-$180k USD depending on experience + bonus + benefits.

    If you are interested in this position, I would like to set up a call to discuss in further detail. Please let me know you earliest availability, attached to a up to date copy of your CV, ideally in word format.

    Thanks and I look forward to speaking with you.

  • Clinical Operations

    $135000 - $170000 per annum, + 20% profit share scheme
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    I have a rare opportunity within a small and niche company who are currently growing in the US.

    They have a focus in Oncology, Immunology, Rare and Neurodegenerative diseases. They have achieved over 50 market authorizations to date. Since their inception in 2004, they pride themselves on providing a highly individualised service for their clients, because of this, they have seen consistent growth across the globe. Using first-in-class technology platforms alongside relationship driven flexibility ensures a high level of service. There are office locations globally, spanning across North America, the UK, Europe and Australia.

    I am working to hire a Senior/AD Project Manager role with a strong focus on external facing business development. This role will be directly involved with the senior management of the company, involved in strategic decision making with the growth and development of the company in mind. The right candidate will display complete proficiency in all aspects of full-service Project Management in Phases I through IV in Oncology, with a preference for candidates with experience in any of: immunology, neurology, CAR-T or gene therapy.

    The role offers home working flexibility, with a minimal need for travel, only travelling when necessary. As such, this role is open to candidates across the whole of the US. The role reports directly into VP level.

    You can expect a salary range from $135k-$170k with an excellent benefits package. There is a big emphasis on a healthy work life balance, providing flexibility with PTO.

    Do you know anyone who would be open to discuss further details?

  • Clinical Operations

    $90000 - $125000 per annum
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    I am partnered with a World-class SME organisation at present to hire multiple Clinical Safety Manager roles – from Safety Manager II to Associate Director level.

    The company is dedicated to developing their employees in the long term, meaning there is a good opportunity to expand scope of responsibility (including line management if desired). Candidates will be expected to have displayed a stable career background, they have very low turnover, we have had excellent feedback from recent placements and they are a diverse and flexible employer.

    They are looking for an individual with several years of experience of clinical safety or pharmacovigilance within a CRO environment. The ideal candidate will currently be working under the same or closely aligned job title. Project management experience is preferred. Full proficiency within reviewing protocols and assessing all safety aspects of clinical trials. Weekly sponsor meetings to maintain clarity on on-going projects, ensuring set timelines are met.

    This position is remote for experienced candidates, however its is preferred if candidates are more junior or close to their offices then some attendance would be ideal. They have offices in Cincinnati, Dallas and Texas. Direct reports are dependent on seniority and WFH arrangements. You can expect a salary range between $90k-$125K + bonus with excellent benefits.

  • Clinical Operations

    £80000 - £95000 per annum, Excellent package
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    Senior Clin Ops role with an Oncology focussed Biopharma in London. Working at program level and leading their leading programs and line managing a small team.

    This is a rare opportunity to join a reputable Biopharmaceutical company with a great reputation, they have a great pipeline spanning phase I-III and trials being run globally. They are growing and will offer excellent long-term opportunities. We have had excellent feedback from recent placements.

    They are recruiting for a Clinical Program Manager / AD role due to growth and new studies coming up, you would be leading their high profile programs in Oncology and they need a vastly experienced individual, with Oncology trial management and line management experience. They want someone who can work at a senior level and take on a leadership role in the team. It could be haematology or solid tumours.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in London. They will offer an excellent salary and package – around £80-905K basic salary + bonus + benefits + stock.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Clinical Operations

    £75000 - £95000 per annum, Excellent package
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    Global Clinical Program Manager position – purely working in Advanced therapies Oncology. Study responsibility and line management of a small team.

    This is a great opportunity to join a World-class Biopharmaceutical company with a strong reputation, they have a great pipeline spanning phase I-III and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in Oncology at present and we have had excellent feedback from recent placements.

    They are recruiting for a Global Clinical Program Manager role due to growth, you would be leading their high profile programs in advanced therapies Oncology and they need a vastly experienced individual, with Oncology trial management and line management experience. They want someone who can work at a senior level and take on a leadership role in the team.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in the London area. They will offer an excellent salary and package – around £75-95K basic salary + excellent bonus + benefits + stock.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Clinical Operations

    £50000 - £65000 per annum, bonus + benefits
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    I am partnered with an exciting Pharma client in the London area to help grow their Infectious Disease team.

    This growing Pharmaceutical company works across a range of areas of unmet medical need including Infectious Disease. They are a fantastic organisation who offer excellent development opportunities. Given their success in bringing products to market and rate of growth, this is a rare and exciting proposition. This is working in their Infectious Disease business unit.

    They are recruiting for a Clinical Study Manager to join the team and need an experienced and accomplished Project/Study Manager with international trial management experience. Pharma/Biotech experience is preferred but they will consider people from CRO. Infectious disease or vaccines experience would be a plus but not required.

    This is a full-time and permanent role, it would be home-based initially and they would want someone in the office several days per week post-COVID. The office is based in the London area. There is an excellent salary and package on offer – £50-65K depending on experience + bonus + benefits.

    Skills Alliance are the exclusive partner for this position, please get in touch with Mark Anderson to find out more on +44 207 220 6209 or APPLY NOW.

  • Clinical Operations

    £60000 - £78000 per annum, excellent package
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    A rare opportunity to join a growing Gene Therapies focussed Biotech. This is a permanent Senior Clinical Study Manager role based in Central London.

    This exciting and innovative Biotech company are at early stages with trials working in advanced therapies. They are expanding at present and will offer great long-term prospects. The company are looking for a very experienced Senior Clinical Study Manager or Senior Clinical Trial Manager, this would be working on complex and fast-paced studies from phase I-III. They require substantial clinical trial management experience, ideally experience in early phase, complex TAs and international trial management experience. They have multiple programs ongoing and have a global presence.

    This is a full-time and permanent position. It is office-based in the London with flexibility to work from home (home-based during the pandemic). They offer an excellent salary and package around GBP 70-80K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this new Senior CPM / Senior CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Operations

    £60000 - £80000 per annum, excellent package
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    A rare opportunity to join a growing early stage Biotech as they build their clinical team. This is a permanent Senior Clinical Study Manager role, mainly home-based with a little travel to the office – Cambs/Herts.

    This exciting and innovative Biotech company are at early stages with trials and just progressing into the clinic. They are expanding at present and will offer great long-term prospects. The company are looking for a very experienced Senior Clinical Study Manager or Senior Clinical Trial Manager, this would be working on complex and fast-paced studies in phase I initially. They require substantial clinical trial management experience, ideally experience in early phase, complex TAs and ideally Biotech experience and/or the ability to work in a fast-paced and ambiguous environment.

    This is a full-time and permanent position. It is mainly home based – going to the office a few days per week. They offer an excellent salary and package around GBP 60-80K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this new Senior CPM / Senior CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Quality

    €35000 - €45000 per annum, 38,5 Stunden, Flexible Arbeitszeiten, Job-Ticket, 13 Gehälter
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    Unser großer Big Pharma Kunde sucht für seinen neuen Standort in Hamburg eine*n Labortechniker*in in der Qualitätssicherung.

    Ihre Aufgaben:

    • Biochemischer und physikalischer Analytik von Rohstoffen, Hilfsstoffen und APIs im Zusammenhang der mRNA-Herstellung
    • Begleitung der Musterzüge von Rohmaterialien und weiteren chemischen Hilfsstoffen
    • Sicherstellung einer GMP-gerechten Dokumentation
    • Assistenz in der Methodenvalidierung durch Zusammenarbeit mit fachlichen Experten
    • Optimierung von Analysemethoden in Zusammenarbeit mit den Fachabteilungen
    • Handling von Rückstellmustern, Kontrolle von GMP Dokumentationen, Bearbeitung von OOX Untersuchungen und Abweichungen
    • Erstellung von Prüfmethoden, SOP’s und Bedienungsanleitungen


    Ihr Profil:

    • Abgeschlossene Berufsausbildung als Chemielaborant, CTA, Biologielaborant, BTA, PTA oder vergleichbar
    • Berufserfahrung im GMP-regulierten Umfeld sowie Kenntnisse und Erfahrungen in der (bio)chemischen Analytik von Arzneimitteln oder artverwandten Stoffen
    • Möglichst Kenntnisse und Erfahrungen in den analytischen Methoden der Photometrie, Kapillarelektrophorese (CE), Arzneibuch Methoden (Ph. Eur.)
    • Sehr gute Deutschkenntnisse in Wort und Schrift sowie möglichst Englischkenntnisse gut in Wort und Schrift

    Erkennen Sie sich wieder?
    Senden Sie gerne Ihre Bewerbung oder Ihre Rückfragen an:

    Fritz Köster
    fritz.koester@skillsalliance.com
    +49 69 955 654

  • Quality

    €65000 - €75000 per annum, 13 Gehälter, Flexible Arbeitszeiten, Halb-Bezuschussung für ein ÖPNV-Ticket Raum Hamburg
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    Einer unserer Big Pharma Kunden sucht für seinen allerneusten Standort im wunderschönen Hamburg zum nächstmöglichen Zeitpunkt eine*n Qualifizierungsingenieur*in (m/w/d). Diese neue Herausforderung wirbt vor allem mit einem kompletten Neustart und großem Wachstumspotenzial, Möglichkeiten zur freien Entwicklung ohne festgefahrene Prozesse, einem neuen Gebäude und breite Möglichkeiten, sich selbst einzubringen.

    Ihr Aufgabengebiet:

    • Qualifizierung von Laborgeräten
    • Organisation und Erstellung von Qualifizierungsaktivitäten gemäß cGMP-Regularien für individuelle Projekte
    • Aufsetzung von Qualifizierungsdokumenten (DQ, IQ, OQ, PQ) gemäß aktuellen Regularien und SOPs
    • Aktivitäten rund um Testpläne und Berichte für Neugeräte
    • Cross-funktionale Zusammenarbeit mit anderen Abteilungen
    • Koordination und Kommunikation mit Fremdfirmen
    • Erstellung und Aktualisierung von SOPs und anderen Vorgabedokumenten
    • Ggfs. Prozessvalidierung
    • Ggfs. Computer System Validierung

    Interessante Tätigkeiten? Das sollten Sie mitbringen:

    • Ein abgeschlossenes Studium in (vorzugsweise) einem ingenieurwissenschaftlichem Studium oder einer anderen naturwissenschaftlichen Disziplin
    • Berufserfahrung in der Pharmaindustrie und bestenfalls der Qualifizierung von Laborgeräten
    • Kenntnis in den GMP-Anforderungen für den Pharmabereich sowie in den dazugehörigen Regularien (ICH, EG GMP, FDA) wünschenswert
    • Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift

    Neugierig auf diese neue Herausforderung? Lust, bei einem Big Player von Anfang an mit dabei zu sein?
    Bewerben Sie sich gerne oder kontaktieren Sie Fritz Köster für weitere Informationen und Rückfragen!

    fritz.koester@skillsalliance.com
    +49 69 50 955 654
    https://www.linkedin.com/in/fritzkoester/

  • Medical Devices

    €60000 - €80000 per annum, Attraktive Sozialleistungen
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    Unser Kunde im schönen Unterfranken sucht nach Verstärkung in seinem Regulatory Affairs Team! Ein geeigneter Kandidat sollte in jedem Fall Erfahrung in der Arbeit mit aktiven und sterilen Medizinprodukten und/oder Software mitbringen. Lesen Sie unten weiter, ob die Stelle Ihr Interesse weckt und auf Ihre Kenntnisse passt:

    Ihr Tätigkeitsbereich

    • Verantwortung für internationale Registrierungs- und Re-Registrierungsprojekte für aktive und sterile Medizinprodukte
    • Planung und Durchführung von komplexen internationalen Zulassungsprojekten mit unseren lokalen Partnern / Distributoren
    • Mitwirkung an der Entwicklung von internationalen Zulassungsstrategien für aktive Medizinprodukte und Koordination mit dem F&E-Team
    • Mitwirkung an Änderungsanträgen zu zulassungsrelevanten Themen und Überprüfung normativer und regulatorischer Anforderungen (auch international)
    • Überprüfung interner Dokumente (z. B. Etikettierung, Werbematerialien, Schulungsunterlagen)
    • Kontinuierliche Unterstützung der Projektteams in regulatorischen Fragen, insbesondere auch während der Entwicklungsphase
    • Überprüfung von Änderungen im regulatorischen Umfeld und Mitteilung relevanter Änderungen an das Unternehmen, um eine kontinuierliche Einhaltung zu gewährleisten
    • Erstellung von Verfahren und internen Standards nach Bedarf (z. B. SOPs, Arbeitsanweisungen, Formulare und Checklisten)

    Ihr Profil

    • Abgeschlossenes Studium der im (Medizin-)technischen Bereich oder einer verwandten Disziplin
    • Mindestens 3-5 Jahre einschlägige Berufserfahrung
    • Erfahrung in der Zertifizierung und internationalen Registrierung von aktiven oder sterilen Medizinprodukten und in der Erstellung von Zulassungsdossiers
    • Erfahrung in der Entwicklung aktiver Medizinprodukte oder Software-Entwicklung
    • Kenntnisse der EU-, US- und weltweiten Vorschriften für Medizinprodukte
    • Kenntnisse der einschlägigen Normen und zugehörigen Prüfverfahren wie IEC 60601-1, IEC 60601-2-22, IEC 60601-1-2, IEC 60601-1-6, IEC 60825, IEC 62304 sowie der entsprechenden Spezifikationen für sterile Medizinprodukte
    • Erfahrung in der Arbeit in multidisziplinären und internationalen Projektteams

    Soweit nach Ihrem Geschmack? Rückfragen können Sie gerne an Fritz Köster stellen:

    fritz.koester@skillsalliance.com | +49 69 50 955 654

    Wir freuen uns auf Ihre Bewerbung!

  • Medical Devices

    €75000 - €85000 per annum, Flexible Arbeitszeiten, Fahrtkostenzuschuss, Kindergartenzuschuss, Betr. Altersvorsorge, individuell leistungsgerechte Gehaltsen
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    Unser Kunde, ein mittelständisches Familienunternehmen im wunderschönen Norden Deutschlands sucht einen Manager in Sachen Sterilisation. Der Kunde ist ein etablierter und führender Anbieter von Medizinprodukten und führt seit mehr als 50 Jahren Innovationen in seinem Bereich an. Sein umfangreiches Produktportfolio ermöglicht Exporte in bereits mehr als 50 Ländern und ist somit international bekannt.

    Als Manager*in in der Sterilisation wäre dies ihr Aufgabengebiet:

    • Erstellung von Plänen und zugehörigen Berichten zur Biologischen Sicherheit gemäß ISO 10993-1
    • Koordination von Biokompatibilitätsprüfungen und Kommunikation mit externen Prüflaboren
    • Auswertung und Dokumentation von Prüfberichten
    • Planung, Durchführung und Überwachung von Sterilisationsvalidierungen (vorzugsweise Ethylenoxid sowie Gamma-Sterilisationsverfahren)
    • Kommunikation mit externen Sterilisationsdienstleistern sowie Koordination von entsprechenden Verfahrensabläufen
    • Bewertung von Validierungsberichten (insbesondere Verpackung und Sterilisation)
    • Screening, Bereitstellung und Umsetzung von relevanten Normenanforderungen unter Berücksichtigung des Stands der Technik
    • Erstellung relevanter Kapitel der Technischen Dokumentation gemäß Verordnung (EU) 2017/745
    • Kommunikation mit Lieferanten, Projektpartnern und Anwendern (national/ international)

    Für diese Stelle müssten Sie dieses Profil mitbringen:

    • Abgeschlossenes Studium (Chemie / Toxikologie, Biologie oder vergleichbar)
    • Fachkenntnis für Ethylenoxid sowie Gamma-Sterilisationsverfahren
    • Erfahrung in den Bereichen Biokompatibilität und Sterilisation
    • Kenntnisse von den entsprechenden einschlägigen Standards (ISO 10993, ISO 11135, ISO 11137, ISO 116076, REACH, RoHS)
    • Kenntnisse in den normativen und regulatorischen Anforderungen an Medizinprodukte (ISO 13485:2016, Richtlinie 93/42/EWG und Verordnung (EU) 2017/745
    • Selbstständige, strukturierte und zielorientierte Arbeitsweise
    • Engagement und Leistungsbereitschaft
    • Bereitschaft zu abteilungsübergreifendem Arbeiten
    • Sehr gute Englischkenntnisse in Wort und Schrift

    Erkennen Sie sich mit Ihren Stärken wieder? Bewerben Sie sich gerne! Bei Rückfragen melden Sie sich gerne per Mail an

    fritz.koester@skillsalliance.com.
    +49 69 50 955 654

    Ich freue mich auf Ihre Mail / Ihren Anruf / Ihre Bewerbung!

  • Quality

    Competitive
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    Neue Möglichkeit zum Jahresbeginn

    Aktuell sucht einer unserer Kunden einen QA Auditor (m/w/d) zum nächstmöglichen Zeitpunkt.
    Der innovative und internationale Arzneimittelhersteller mit Sitz im Raum Berlin ist bereits seit über 75 Jahren am Markt konnte in den letzten Jahren durch die Entwicklung von Arzneimittelinnovationen seine Kapazitäten weiter ausbauen.
    Auf seiner Wachstumsreise ist das Unternehmen nun auf der Suche nach einem neuen Teammitglied.

    Das sind Ihre Aufgaben:

    • Planung, Vorbereitung, Durchführung und Nachverfolgung von Audits bei Auftragnehmern und Lieferanten
    • Qualifizierung von Lieferanten, Auftragnehmern und Dienstleistern
    • Durchführung von Selbstinspektionen und Unterstützung bei externen Inspektionen
    • Erstellen von Auswertungen zur periodischen Berichtserstattung bei qualitätsbezogenen Fragen
    • Teilnahme an Due-Diligence-Prüfungen
    • Unterstützung beim Abweichungsmanagement und der Veranlassung und Nachverfolgung von CAPA-Maßnahmen
    • Leitung von Projektteams zur reibungslosen Bearbeitung aktueller GMP/GDP-Aufgaben
    • Mitwirken bei der Aus- und Weiterbildung von Apothekern und Pharmazeuten im Praktikum

    Das bringen Sie mit:

    • Promovierter Pharmazeut
    • 6+ Jahre Berufserfahrung in der pharmazeutischen Qualitätssicherung
    • Ausgezeichnete GMP/GDP-Kenntnisse sowie Expertise in der Auditierung und der Durchführung von Selbstinspektionen
    • Ausgeprägte Präsentations- und Moderationsfähigkeiten
    • Erfahrung und gute Kenntnisse in der Leitung von nationalen/internationalen Projekten
    • Sehr gute Deutsch- und Englisch-Kenntnisse in Wort und Schrift
    • Internationale Reisebereitschaft

    Falls Ihr Interesse geweckt wurde, kontaktieren Sie Luis Freitag unter luis.freitag@skillsalliance.com oder telefonisch unter +496950955657.

  • Apply

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    Share

    Skills Alliance are retained on a unique opportunity with an innovative vaccine organisation. They are hiring for multiple PMs due to increased investment and expansion.

    The organisation specialises in vaccine development, partnering with Pharmas and Biotechs to combat epidemic outbreaks such as COVID and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference. They are very well funded and are an employer who is very focused on diversity.

    The Senior Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous cross-functional project management experience, ideally managing projects from phase I-III. They will consider experienced PMs from Pharma, Biotech or CRO and vaccines experience would be a strong preference. The feedback from recent placements has been outstanding.

    This is a full-time and permanent position to be home-based with infrequent travel as necessary for business when normality resumes. They will offer a very competitive salary depending on experience + full benefits package.

  • Quality

    Competitive
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    Bereit für eine neue Herausforderung?

    Aktuell sucht einer unserer Kunden einen Mitarbeiter QA/QC (m/w/d) zum nächstmöglichen Zeitpunkt.
    Der besonders junge und innovative Arzneimittel- und Plattformanbieter aus der Metropolregion Berlin ist in einem international stark wachsendnen Markt tätig, hat dessen nationale Entwicklung mitgeprägt und vorangetrieben. Neben einem breiten Produktportfolio bietet das Unternehmen außerdem attraktive Lösungen für Patienten an und befindet sich auf einem stetigen Wachstumskurs, weshalb derzeit Verstärkung für das Quality-Team gesucht wird.

    Das sind Ihre Aufgaben:

    • Pflege des QA-Systems, sowie betäubungsrechtlicher Dokumente
    • Erstellung und Aktualisierung von qualitätsbezogenen Dokumenten
    • Unterstützung bei der Lieferanten- und Lohnherstellerqualifizierung
    • Prüfung von herstellungsbezogenen Protokollen und Dokumenten, sowie Mitwirken bei Prüfungen des Wareneingangs/-ausgangs
    • Bearbeiten von Reklamationen und Abweichungen
    • Verfassen von SOPs und Prozessdokumentationen

    Das bringen Sie mit:

    • Studium oder Ausbildung mit pharmazeutischem Hintergrund
    • Mindestens ein Jahr Berufserfahrung
    • Kenntnisse über nationale Regularien (AMWHV, GMP, AMG)
    • Kenntnisse im Bezug auf Betäubungsmittel (BtMG)
    • Sehr gute Deutsch- und Englisch-Kenntnisse in Wort und Schrift
    • Verantwortungsvolle und zuverlässige Arbeitsweise

    Benefits für Sie:

    • Flache Hierarchien, regelmäßige Feedbackgespräche mit Vorgesetzten
    • Gute Karrierechancen in einer stark wachsenenden Branche
    • Flexible Arbeitszeiten und Möglichkeit zu Home-Office
    • 30 Tage Urlaub
    • Regelmäßige Team-Events

    Falls Ihr Interesse geweckt wurde, kontaktieren Sie Luis Freitag unter luis.freitag@skillsalliance.com oder telefonisch unter +496950955657.

  • Quality

    negotionable
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    Michael Parker at Skills Alliance is currently recruiting several extremely exciting GCP auditor roles. My client are an exciting consultancy that have huge growth plans. The consultancy specialises in QA work solely across all areas of GxP.

    This role is to focus on their huge demand of GCP work their clients need, the clients range from small hyper growth Biotechs to large pharma.

    This is a great opportunity for someone with circa 5 years+ GCP auditing experience to broaden their experience and gain invaluable training and development. You will also get the opportunity to work with UK or global clients as well as get experience in other areas of GxP should you desire.

    The role will cover all areas of external auditing and be completely home based + travel. Below are some of the key responsibilities

    • Plan, conduct, report and follow up contracted audits within agreed budget and timelines
    • Conduct technical peer reviews and provide feedback on client deliverables
    • Assist with the preparation and facilitation of audits and regulatory inspections of clients, and work with responsible parties to prepare Corrective Action and Preventative Action (CAPA) plans as applicable
    • Provide strategic advice to clients on Quality Management System development and change
    • Provide a consultancy service for GCP and/or additional regulations
    • Develop and deliver training programs and/or materials
    • Manage the fulfillment of assigned contracted activities, identifying identify and escalate any potential out-of-scope activities
    • Keep relevant manager(s)/project manager, and the client where applicable, informed of the progress of all assigned contracted activities and any issues that may arise by providing regular updates and maintaining effective communication
    • Foster and maintain good, professional working relationships with clients and identify new business opportunities
    • Assist with the preparation of proposals and presentations to prospective clients

    Skills Required

    • Thorough knowledge of GCP and/or other applicable regulatory requirements
    • Excellent attention to detail, organisation, and prioritisation skills
    • Strong interpersonal skills, verbal and written skills, and the ability to communicate confidently at all levels
    • Self-motivation and ability to function independently and within a team
    • Ability to function calmly under pressure
    • Practical and enquiring approach to problem-solving
    • Dedication to quality and reliability in all aspects of work
    • Responsiveness to customer needs and focus on customer satisfaction

    This role is urgent so please get in touch as soon as possible if this is something you are interested in. Please note this role is only eligible for candidates based in the UK or eligible to work in the UK without sponsorship.

  • Quality

    Negotiable
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    Michael Parker at skills alliance is recruiting a Senior QC Operative. I am working with one of the largest privately owned import and distribution companies in the UK. They are based in the West Midlands, just outside of Birmingham. They are looking for a several new roles in QA working across both GMP, GDP & QC. Over the pandemic their ability to be nimble has meant they have actually grown and have made several hires in QA this year.

    Overall Objective:
    To be efficient in processing the work within the QC Department. Have a good knowledge of and always adhere to the company’s Standard Operating Procedures and comply with both Good Manufacturing Practice and Good Distribution Practice at all times. To comply with all company Health & Safety Policies, Procedures, Work Practices ensuring accuracy and quality and any other Health & Safety requirements at all times.
    __________________________________________________________________________________________
    Duties and Responsibilities:

    • Review and inspect incoming EU deliveries to verify the consignment has been received in an acceptable condition with no visible damages, indication of tampering, and that it is from an approved active supplier. The consignment was shipped securely under acceptable environmental conditions by an approved transport provider. Any products requiring special or secure storage requirements (temperature sensitive stock or controlled drugs) are processed in a timely manner and transferred to the appropriate location.
    • Record all relevant details of deliveries received on the company system.
    • Performing identity checks on raw product and reporting any discrepancies with the associated specification.
    • Ensuring all checks are recorded accurately during identification check.
    • Ensuring photographs of raw product are taken showing all faces (outer and inner) with batch number, expiry date and EU/ECMA visible and attached to batch documentation.
    • Ensuring all Italian sourced consignments undergo a Bollino authenticity check.
    • Ensuring all Greek sourced stock undergoes a Vignette authenticity check.
    • In process checks during production.
    • Performing a line clearance prior to and post QC final verification checks and completing the line clearance logbook accordingly.
    • Ensuring all relevant documentation is present with the working BPR and confirmed as complete.
    • Inspect materials or products being produced and recording outcomes in the relevant documentation.
    • Compering materials or products against a pre-defined standard specification.
    • Approving or rejecting components, packaging materials and finished products.
    • Ensure that if errors occurred, that they have been reported.
    • Check performs on the pre-printed packaging materials:
    • Removing and checking number of samples specified in the sampling plan for packaging material (number of samples is determined by QA personnel).
    • Escalating any quality defects to the QA who will assess the conformance or non-conformance of packaging material.
    • Performing identification check on the random sample that represents the batch; if any discrepancies related to the starting material or/and finished product found at this point, QC quarantines the whole unit.
    • Reviewing the batch records and ensuring all entries are inserted accurately.

    Support QC Manager:

    • Ensuring QC staff always comply with the applicable GMP requirements and associated processes and procedures.
    • Reporting any errors/non-compliances as quality incidents. Ensuring the details of any events or deviations raised are accurately recorded in the applicable controlled document (including the corresponding references).
    • Informing the operations manager of product related quality incidents as soon as possible.
    • Escalating any issues or concerns to The Quality Director, GMP QA Manager or RP.
    • Provide advice to staff regarding the quality standards.
    • Monitor operations to ensure compliance with quality standards.
    • Providing assistance to production staff where necessary regarding the quality standards.
    • Ensuring all retention samples are stored securely.
    • Ensuring all completed and signed batch records are stored securely.
    • Monitoring retention periods for batch documentation and retention samples.


    This is an urgent role so please get in touch as soon as possible if you are interested.

  • Quality

    Negotiable
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    Michael Parker at skills alliance is recruiting a QA Officer to specialise in GDP. I am working with one of the largest privately owned import and distribution companies in the UK. They are based in the West Midlands, just outside of Birmingham. They are looking for a several new roles in QA working across both GMP, GDP & QC. Over the pandemic their ability to be nimble has meant they have actually grown and have made several hires in QA this year.

    Overall Objective:
    Provision of QA support for the management and continual improvement of the company QMS, to ensure it meets the requirements of the company licences (including WDA(H)s and MIA), and the relevant parts of GDP and GMP at all times.
    Work effectively with other departments within the business as necessary, to ensure compliance with all relevant company and regulatory standards and maintain the safety, quality and efficacy of all products procured, handled, repackaged and supplied by the company.
    Support other members of the Quality department as necessary.


    Duties and Responsibilities:

    • Support maintenance and continual improvement of the company QMS by preparation, review, approval, training and implementation of SOPs and work instructions, as necessary.
    • Monitor changes in applicable GMP/GDP legislation and guidelines and support implementation of any necessary changes.
    • Identify compliance gaps and make recommendations for continuous improvement.
    • Manage own workload to ensure all tasks are completed within the timelines assigned to meet business needs and customer requirements.
    • Ensure the requirements of applicable product licences (e.g. PLPI, PLGB) are considered and adhered to as necessary.
    • Investigate and report quality incidents, utilising root cause analysis tools as necessary and applying an appropriate risk-based approach. Ensure all quality events and deviations are investigated to an appropriate level and are completed and reported in a timely manner.
    • Propose, implement, and monitor appropriate CAPA plans to address the root cause (or other causal/contributing factors) of non-conformances and ensure the effectiveness of all actions is monitored, as necessary.
    • Investigate and report complaints in a timely manner.
    • Prepare, co-ordinate and manage change controls.
    • Compile and review periodic product quality review reports.
    • Support product recalls where necessary.
    • Perform risk assessments.
    • Perform and report internal and external audits and housekeeping inspections, in accordance with the company audit schedules.
    • Support customer audits and regulatory inspections, as necessary.
    • Document control and archiving-adding new documents to Master Document List, ensure controlled documents are reviewed by periodic review date. Issuing controlled documents and reconcile superseded versions and archiving quality documents.
    • Review QMS documents (e.g. SOPs, work instructions, events, deviations, change controls etc.), ensuring all necessary requirements and standards are considered and approve as necessary.
    • Perform required checks to verify the authenticity of supplied products.
    • Prepare and deliver training, including preparation of training materials and competency assessments.
    • Perform and attend all necessary training and ensure a record of all training is maintained.
    • Perform qualification and/or quality audits and assessments to support approval of suppliers, customers, and service providers.
    • Monitor all suppliers, customers and service providers to ensure they are maintained in a qualified / approved status, taking into account any supply, service or other issues arising during routine use.
    • Generate and review Technical Agreements (TAs) with suppliers, customers and service providers.
    • Monitor the QMS and perform trend analysis. Propose and implement CAPA to address the outcomes from trend analysis as necessary, including potential process efficiency improvements.
    • Provide data, metrics and reports as necessary to monitor the suitability and effectiveness of the QMS. Attend and contribute to Quality Management Review (QMR) meetings. Generate minutes and actions of meetings when required.


    This is an urgent role so for full details please get in contact as soon as possible.


  • HR and talent acquisition

    £55000 - £65000 per annum
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    A not-for-profit organisation at the forefront of vaccine research and development to prevent future epidemics, is seeking an experienced Human Resources Business Partner to develop HR processes and contribute to the effective delivery of the international people strategy.

    The HR Specialist will be responsible for:

    • Business Partnering with line managers to support the development and resourcing of their teams
    • Coaching and counselling line managers with skills development and performance issues
    • Lead projects around employee engagement, in line with organisational purpose, culture and values
    • Development and implementation of HR policies and processes
    • Oversee talent acquisition and talent management

    Required experience:

    • Significant experience as business partner to line managers on an international scale
    • Demonstrable experience working within the Life Sciences / Pharmaceuticals industry, either for a profit or non-profit organisation
    • A strategic thinker, with ability to manage operational HR processes
    • Desire to contribute to a wider mission

    Please contact Sarah Brambill at Skills Alliance for more information, or apply for immediate consideration.

  • Quality

    €35000 - €45000 per annum, 38,5 Stunden, Flexible Arbeitszeiten, Job-Ticket, 13 Gehälter
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    Unser großer Big Pharma Kunde sucht für seinen neuen Standort in Hamburg eine*n Labortechniker*in in der Qualitätssicherung.

    Ihre Aufgaben:

    • Biochemischer und physikalischer Analytik von Rohstoffen, Hilfsstoffen und APIs im Zusammenhang der mRNA-Herstellung
    • Begleitung der Musterzüge von Rohmaterialien und weiteren chemischen Hilfsstoffen
    • Sicherstellung einer GMP-gerechten Dokumentation
    • Assistenz in der Methodenvalidierung durch Zusammenarbeit mit fachlichen Experten
    • Optimierung von Analysemethoden in Zusammenarbeit mit den Fachabteilungen
    • Handling von Rückstellmustern, Kontrolle von GMP Dokumentationen, Bearbeitung von OOX Untersuchungen und Abweichungen
    • Erstellung von Prüfmethoden, SOP’s und Bedienungsanleitungen


    Ihr Profil:

    • Abgeschlossene Berufsausbildung als Chemielaborant, CTA, Biologielaborant, BTA, PTA oder vergleichbar
    • Berufserfahrung im GMP-regulierten Umfeld sowie Kenntnisse und Erfahrungen in der (bio)chemischen Analytik von Arzneimitteln oder artverwandten Stoffen
    • Möglichst Kenntnisse und Erfahrungen in den analytischen Methoden der Photometrie, Kapillarelektrophorese (CE), Arzneibuch Methoden (Ph. Eur.)
    • Sehr gute Deutschkenntnisse in Wort und Schrift sowie möglichst Englischkenntnisse gut in Wort und Schrift

    Erkennen Sie sich wieder?
    Senden Sie gerne Ihre Bewerbung oder Ihre Rückfragen an:

    Fritz Köster
    fritz.koester@skillsalliance.com
    +49 69 955 654

  • Scientific

    Competitive
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    Share

    Bereit für eine neue Herausforderung?

    Aktuell sucht einer unserer Kunden aus München einen Chemielaboranten (m/w/d) zum nächstmöglichen Zeitpunkt.
    Das junge Unternehmen entwickelt und produziert onkologische Diagniostik- & Therapielösungen ist in den letzten vier Jahren stark gewachsen. Während das Unternehmen ab diesem Jahr an mehreren spannenden Projekten arbeiten wird, wird aktuell das Team vergrößert.

    Das sind Ihre Aufgaben:

    • Eigenständige Durchführung von Qualitäts- und Stabilitätsprüfungen von Radiopharmazeutika, Medizinpropdukten und Rohstoffen unter Einhaltung der GMP-Richtlinien
    • Vorbereitung von Proben, Dokumentation von Prüfungen und Auswertung von Ergebnissen
    • Unetrstützung bei der Entwicklung, Optimierung und Validierung von Analysemethoden
    • Qualifizierung, Kalibrierung von Analysegeräten und Prüfmitteln, sowie Durchführung von Wartungen

    Das bringen Sie mit:

    • Abgeschlossene Ausbildung zum Chemielaboranten oder CTA oder vergleichbare Qualifikation
    • Berufserfahrung auf dem Gebiet der chemischen oder pharmazeutischen Analytik
    • Erfahung in GMP-reguliertem Umfeld ist von Vorteil
    • Sehr guter Umgang mir MS Office und MS Excel
    • Egenständige, systematische und zuverlässige Arbeitsweise
    • Offene, kommunikative Persönlichkeit
    • Hohes Maß an Teamfähigkeit und Flexibilität
    • Gute Englischkenntnisse in Wort und Schrift
    • Bereitschaft zur Schichtarbeit

    Falls Ihr Interesse geweckt wurde, kontaktieren Sie Luis Freitag unter luis.freitag@skillsalliance.com oder telefonisch unter +496950955657.

  • Quality

    Competitive
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    Share

    Neue Möglichkeit im Raum München!

    Wir suchen derzeit für einen Kunden aus der Region München einen Quality Assurance Mitarbeiter GCP (m/w/d). Das junge und moderne Unternehmen entwickelt und produziert onkologische Diagniostik- & Therapielösungen, ist in den letzten vier Jahren stark gewachsen. Während mehrere spannende Projekte für die nächsten Jahre geplant sind, werden Sie als Unterstützung zum nächstmöglichen Zeitpunkt gesucht.

    Das sind Ihre Aufgaben:

    • Unterstützung bei der Umsetzung des Qualitätsplans
    • Ermittlung von Indikatoren, die zur Bewertung des Qualitätsniveaus erforderlich sind
    • Bewertung von Qualitätsaktivitäten anhand von Unternehmensstandards und gesetzlichen Anforderungen
    • Einsatz bei Audits (intern, am Standort, bei Lieferanten) und Überprüfung von Peer-Reviews
    • Entwicklung/Überarbeitung von QMS-Richtlinien, SOPs, Arbeitsanweisungen, Standards und Schulungsmaterialien nach Bedarf
    • Unterstützung der Abteilungen bei der Auslegung der gesetzlichen Anforderungen
    • Aufrechterhaltung des aktuellen Stands und Sicherstellung des internen Bewusstseins für relevante gesetzliche Anforderungen, Industriestandards und -anforderungen
    • Unterstützung bei der Identifizierung von QMS-Dokumenten und/oder Schulungsanforderungen zur Erfüllung von Vorschriften, Standards und Erwartungen der Auftraggeber
    • Mitwirken bei Auftraggeber- und behördlichen Inspektionen oder Auditaktivitäten
    • Identifizierung, Erstellung, Anpassung und Durchführung von Schulungsprogrammen und -instrumenten zur Qualitätssicherung für Abteilungen, Projektteams und klinische Einrichtungen
    • Überwachen der Einhaltung von Schulungsmaßnahmen in der Organisation

    Das bringen Sie mit:

    • B.Sc. in Chemie oder vergleichbare Ausbildung
    • Mindestens 2 Jahre einschlägige Berufserfahrung
    • Gute Kenntnisse in der Prozessoptimierung, einschließlich der Erstellung und Pflege von Standardarbeitsanweisungen (SOPs)
    • Erfahrung in der Qualitätssicherung oder Softwareentwicklung ist von Vorteil
    • GCP-Kenntnisse sind von Vorteil
    • Ausgezeichnete mündliche und schriftliche Kommunikationsfähigkeiten in Deutsch und Englisch
    • Hohes Maß an Aufmerksamkeit für Details
    • Gute zwischenmenschliche Beziehungen und Fähigkeiten zur Zusammenarbeit in funktionsübergreifenden Teams
    • Organisierter, selbstgesteuerter und auf Effizienz bedachter Arbeitsstil
    • Flexibilität bei wechselnden Prioritäten und die Fähigkeit, in einem sich ständig verändernden Umfeld zu arbeiten

    Falls Ihr Interesse geweckt wurde, kontaktieren Sie Luis Freitag unter luis.freitag@skillsalliance.com oder telefonisch unter +496950955657.

  • Clinical Operations

    £55000 - £65000 per annum, bonus + shares + benefits
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    (SENIOR) CLINICAL STUDY MANAGER – BIOTECH – HOME-BASED ACROSS UK – PERMANENT (BONUS + SHARES)

    I am partnered with a small and fast growing early phase Biotech based at present who are recruiting for an Early Phase Clinical Study Manager or Senior Clinical Study Manager.

    This is a rare opportunity to join a small Biotech, they are moving into the clinic with their first studies and they need an experienced and autonomous Clinical Trial Manager or Senior Clinical Trial Manager who has worked in Pharma or Biotech previously and managed phase I studies.

    They are working on interesting studies in an exciting therapeutic area and have a platform that can be applied to a range of further TAs in the future. Naturally it is a great time to join as they have doubled in size in the past year.

    The position is permanent, full-time and home-based unless attending important meetings in the office. They will offer an excellent salary – circa £55-65K + bonus + share options + benefits.

    Skills Alliance are the exclusive partner for this position. Please get in contact with Mark Anderson for more details – mark.anderson@skillsalliance.com

  • Quality

    Negotiable
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    Michael Parker at skills alliance is recruiting a Senior QC Operative. I am working with one of the largest privately owned import and distribution companies in the UK. They are based in the West Midlands, just outside of Birmingham. They are looking for a several new roles in QA working across both GMP, GDP & QC. Over the pandemic their ability to be nimble has meant they have actually grown and have made several hires in QA this year.

    Overall Objective:
    To be efficient in processing the work within the QC Department. Have a good knowledge of and always adhere to the company’s Standard Operating Procedures and comply with both Good Manufacturing Practice and Good Distribution Practice at all times. To comply with all company Health & Safety Policies, Procedures, Work Practices ensuring accuracy and quality and any other Health & Safety requirements at all times.
    __________________________________________________________________________________________
    Duties and Responsibilities:

    • Review and inspect incoming EU deliveries to verify the consignment has been received in an acceptable condition with no visible damages, indication of tampering, and that it is from an approved active supplier. The consignment was shipped securely under acceptable environmental conditions by an approved transport provider. Any products requiring special or secure storage requirements (temperature sensitive stock or controlled drugs) are processed in a timely manner and transferred to the appropriate location.
    • Record all relevant details of deliveries received on the company system.
    • Performing identity checks on raw product and reporting any discrepancies with the associated specification.
    • Ensuring all checks are recorded accurately during identification check.
    • Ensuring photographs of raw product are taken showing all faces (outer and inner) with batch number, expiry date and EU/ECMA visible and attached to batch documentation.
    • Ensuring all Italian sourced consignments undergo a Bollino authenticity check.
    • Ensuring all Greek sourced stock undergoes a Vignette authenticity check.
    • In process checks during production.
    • Performing a line clearance prior to and post QC final verification checks and completing the line clearance logbook accordingly.
    • Ensuring all relevant documentation is present with the working BPR and confirmed as complete.
    • Inspect materials or products being produced and recording outcomes in the relevant documentation.
    • Compering materials or products against a pre-defined standard specification.
    • Approving or rejecting components, packaging materials and finished products.
    • Ensure that if errors occurred, that they have been reported.
    • Check performs on the pre-printed packaging materials:
    • Removing and checking number of samples specified in the sampling plan for packaging material (number of samples is determined by QA personnel).
    • Escalating any quality defects to the QA who will assess the conformance or non-conformance of packaging material.
    • Performing identification check on the random sample that represents the batch; if any discrepancies related to the starting material or/and finished product found at this point, QC quarantines the whole unit.
    • Reviewing the batch records and ensuring all entries are inserted accurately.

    Support QC Manager:

    • Ensuring QC staff always comply with the applicable GMP requirements and associated processes and procedures.
    • Reporting any errors/non-compliances as quality incidents. Ensuring the details of any events or deviations raised are accurately recorded in the applicable controlled document (including the corresponding references).
    • Informing the operations manager of product related quality incidents as soon as possible.
    • Escalating any issues or concerns to The Quality Director, GMP QA Manager or RP.
    • Provide advice to staff regarding the quality standards.
    • Monitor operations to ensure compliance with quality standards.
    • Providing assistance to production staff where necessary regarding the quality standards.
    • Ensuring all retention samples are stored securely.
    • Ensuring all completed and signed batch records are stored securely.
    • Monitoring retention periods for batch documentation and retention samples.


    This is an urgent role so please get in touch as soon as possible if you are interested.

  • Quality

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    Michael Parker at skills alliance is recruiting a QA Officer to specialise in GDP. I am working with one of the largest privately owned import and distribution companies in the UK. They are based in the West Midlands, just outside of Birmingham. They are looking for a several new roles in QA working across both GMP, GDP & QC. Over the pandemic their ability to be nimble has meant they have actually grown and have made several hires in QA this year.

    Overall Objective:
    Provision of QA support for the management and continual improvement of the company QMS, to ensure it meets the requirements of the company licences (including WDA(H)s and MIA), and the relevant parts of GDP and GMP at all times.
    Work effectively with other departments within the business as necessary, to ensure compliance with all relevant company and regulatory standards and maintain the safety, quality and efficacy of all products procured, handled, repackaged and supplied by the company.
    Support other members of the Quality department as necessary.


    Duties and Responsibilities:

    • Support maintenance and continual improvement of the company QMS by preparation, review, approval, training and implementation of SOPs and work instructions, as necessary.
    • Monitor changes in applicable GMP/GDP legislation and guidelines and support implementation of any necessary changes.
    • Identify compliance gaps and make recommendations for continuous improvement.
    • Manage own workload to ensure all tasks are completed within the timelines assigned to meet business needs and customer requirements.
    • Ensure the requirements of applicable product licences (e.g. PLPI, PLGB) are considered and adhered to as necessary.
    • Investigate and report quality incidents, utilising root cause analysis tools as necessary and applying an appropriate risk-based approach. Ensure all quality events and deviations are investigated to an appropriate level and are completed and reported in a timely manner.
    • Propose, implement, and monitor appropriate CAPA plans to address the root cause (or other causal/contributing factors) of non-conformances and ensure the effectiveness of all actions is monitored, as necessary.
    • Investigate and report complaints in a timely manner.
    • Prepare, co-ordinate and manage change controls.
    • Compile and review periodic product quality review reports.
    • Support product recalls where necessary.
    • Perform risk assessments.
    • Perform and report internal and external audits and housekeeping inspections, in accordance with the company audit schedules.
    • Support customer audits and regulatory inspections, as necessary.
    • Document control and archiving-adding new documents to Master Document List, ensure controlled documents are reviewed by periodic review date. Issuing controlled documents and reconcile superseded versions and archiving quality documents.
    • Review QMS documents (e.g. SOPs, work instructions, events, deviations, change controls etc.), ensuring all necessary requirements and standards are considered and approve as necessary.
    • Perform required checks to verify the authenticity of supplied products.
    • Prepare and deliver training, including preparation of training materials and competency assessments.
    • Perform and attend all necessary training and ensure a record of all training is maintained.
    • Perform qualification and/or quality audits and assessments to support approval of suppliers, customers, and service providers.
    • Monitor all suppliers, customers and service providers to ensure they are maintained in a qualified / approved status, taking into account any supply, service or other issues arising during routine use.
    • Generate and review Technical Agreements (TAs) with suppliers, customers and service providers.
    • Monitor the QMS and perform trend analysis. Propose and implement CAPA to address the outcomes from trend analysis as necessary, including potential process efficiency improvements.
    • Provide data, metrics and reports as necessary to monitor the suitability and effectiveness of the QMS. Attend and contribute to Quality Management Review (QMR) meetings. Generate minutes and actions of meetings when required.


    This is an urgent role so for full details please get in contact as soon as possible.


  • Quality

    negotionable
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    Michael Parker at Skills Alliance is currently recruiting several extremely exciting GCP auditor roles. My client are an exciting consultancy that have huge growth plans. The consultancy specialises in QA work solely across all areas of GxP.

    This role is to focus on their huge demand of GCP work their clients need, the clients range from small hyper growth Biotechs to large pharma.

    This is a great opportunity for someone with circa 5 years+ GCP auditing experience to broaden their experience and gain invaluable training and development. You will also get the opportunity to work with UK or global clients as well as get experience in other areas of GxP should you desire.

    The role will cover all areas of external auditing and be completely home based + travel. Below are some of the key responsibilities

    • Plan, conduct, report and follow up contracted audits within agreed budget and timelines
    • Conduct technical peer reviews and provide feedback on client deliverables
    • Assist with the preparation and facilitation of audits and regulatory inspections of clients, and work with responsible parties to prepare Corrective Action and Preventative Action (CAPA) plans as applicable
    • Provide strategic advice to clients on Quality Management System development and change
    • Provide a consultancy service for GCP and/or additional regulations
    • Develop and deliver training programs and/or materials
    • Manage the fulfillment of assigned contracted activities, identifying identify and escalate any potential out-of-scope activities
    • Keep relevant manager(s)/project manager, and the client where applicable, informed of the progress of all assigned contracted activities and any issues that may arise by providing regular updates and maintaining effective communication
    • Foster and maintain good, professional working relationships with clients and identify new business opportunities
    • Assist with the preparation of proposals and presentations to prospective clients

    Skills Required

    • Thorough knowledge of GCP and/or other applicable regulatory requirements
    • Excellent attention to detail, organisation, and prioritisation skills
    • Strong interpersonal skills, verbal and written skills, and the ability to communicate confidently at all levels
    • Self-motivation and ability to function independently and within a team
    • Ability to function calmly under pressure
    • Practical and enquiring approach to problem-solving
    • Dedication to quality and reliability in all aspects of work
    • Responsiveness to customer needs and focus on customer satisfaction

    This role is urgent so please get in touch as soon as possible if this is something you are interested in. Please note this role is only eligible for candidates based in the UK or eligible to work in the UK without sponsorship.

  • Project Management

    £60000 - £75000 per annum, Excellent package
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    Skills Alliance are retained on a unique opportunity with an innovative vaccine organisation. They are hiring for multiple PMs due to increased investment and expansion.

    The organisation specialises in vaccine development, partnering with Pharmas and Biotechs to combat epidemic outbreaks such as COVID and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference. They are very well funded and are an employer who is very focused on diversity.

    The Senior Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous cross-functional project management experience, ideally managing projects from phase I-III. They will consider experienced PMs from Pharma, Biotech or CRO and vaccines experience would be a strong preference. The feedback from recent placements has been outstanding.

    This is a full-time and permanent position to be home-based with infrequent travel to their offices in Central London when normality resumes. They will offer a very competitive salary – circa £60-£75K depending on experience + full benefits package.

    Skills Alliance are the exclusive partner for this role, please get in contact with Mark Anderson for more details – +44 207 220 6209.

  • Project Management

    £40000 - £50000 per annum, Excellent package
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    Skills Alliance are retained on a unique opportunity with an innovative vaccine organisation. They are hiring for multiple Project Coordinators due to increased investment and expansion.

    The organisation specialises in vaccine development, partnering with Pharmas and Biotechs to combat epidemic outbreaks such as COVID and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference. They are very well funded and are an employer who is very focused on diversity.

    The Project Coordinator will support the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible for supporting the PMs with the opportunity to progress into a PM role in the long-term. They require previous CTA or Project Coordination experience. They will consider experienced candidates from Pharma, Biotech or CRO. The feedback from recent placements has been outstanding.

    This is a full-time and permanent position to be home-based with some travel to their offices in Central London when normality resumes. They will offer a very competitive salary – circa £40-50K depending on experience + full benefits package.

    Skills Alliance are the exclusive partner for this role, please get in contact with Mark Anderson for more details – +44 207 220 6209.

  • Project Management

    £65000 - £75000 per annum, Excellent package
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    Skills Alliance are retained on a unique opportunity with an innovative vaccine organisation. They are hiring for multiple PMs due to increased investment and expansion.

    The organisation specialises in vaccine development, partnering with Pharmas and Biotechs to combat epidemic outbreaks such as COVID and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference. They are very well funded and are an employer who is very focused on diversity.

    The Senior Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous cross-functional project management experience, ideally managing projects from phase I-III. They will consider experienced PMs from Pharma, Biotech or CRO and vaccines experience would be a strong preference. The feedback from recent placements has been outstanding.

    This is a full-time and permanent position to be home-based with infrequent travel to their offices in Central London when normality resumes. They will offer a very competitive salary – circa £65-£75K depending on experience + full benefits package.

    Skills Alliance are the exclusive partner for this role, please get in contact with Mark Anderson for more details – +44 207 220 6209.

  • Clinical Operations

    £60000 - £80000 per annum, Bonus + benefits
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    *PHARMA/CRO EXPERIENCE REQUIRED*

    A great opportunity to join a medium-sized CRO with a great culture and low turnover. They are recruiting for PM and Senior PM roles due to organic growth and new studies.

    This company have a great track record and have been very successful during COVID where other CROs have struggled. They are a SME CRO who are dynamic and work in very interesting and complex therapy areas. Studies span phases I-IV and they work in Oncology and Gene Therapy amongst other areas.

    They are recruiting for multiple roles due to new studies coming in and they need an experienced cross-functional PM who has budget management experience. It could be working on a range of studies and would be working globally. There are also opportunities to progress quickly.

    This is a permanent and full-time role. They have an office in the South East but everyone is now home-based and this can be a remote role across the UK. They will offer a very good salary – GBP 60-80K + bonus + benefits.

    Skills Alliance are the preferred supplier for this new Senior CPM / CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • Clinical Development

    £65000 - £75000 per annum, Excellent package
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    Senior Global Clinical Study Manager position – purely working in Oncology, could be solid tumours, haematology or advanced therapies. Study responsibility and line management of a small team.

    This is a great opportunity to join a World-class Biopharmaceutical company with a strong reputation, they have a wide-ranging pipeline spanning phase I-III (and late phase) and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in Oncology at present and we have had excellent feedback from recent placements.

    They are recruiting for a Senior Clinical Study Manager / Senior Global Trial Manager role due to growth and new studies coming up, you would be leading their high profile programs in Oncology and they need a an experienced individual, with Oncology trial management and ideally line management experience. They want someone who can work at a senior level and take on a leadership role in the team. It could be or solid tumours, haematology or in their cell & gene therapy team.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in London. They will offer an excellent salary and package – around £65-75K basic salary + excellent bonus + benefits + stock.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Clinical Operations

    £55000 - £70000 per annum, Excellent package
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    Clinical Study Manager position – purely working in Oncology, could be solid tumours, haematology or advanced therapies.

    This is a great opportunity to join a World-class Biopharmaceutical company with a strong reputation, they have a wide-ranging pipeline spanning phase I-III (and late phase) and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in Oncology at present and we have had excellent feedback from recent placements.

    They are recruiting for a Clinical Study Manager / Clinical Trial Manager role due to growth and new studies coming up, you would be managing their high profile programs in Oncology and they need a an experienced individual, with Oncology trial management. It could be or solid tumours, haematology or in their cell & gene therapy team.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in London. They will offer an excellent salary and package – around £55-70K basic salary + excellent bonus + benefits.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Clinical Operations

    £55000 - £70000 per annum, Excellent package
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    Clinical Study Manager position – purely working in their Infectious Disease/Virology team.

    This is a great opportunity to join a World-class Biopharmaceutical company with a strong reputation, they have a wide-ranging pipeline spanning phase I-III (and late phase) and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in growth at present and we have had excellent feedback from previous placements.

    They are recruiting for a Clinical Study Manager / Clinical Trial Manager role due to growth and new studies coming up, they will offer excellent progression opportunities, with rapid promotion prospects possible for high performing individuals. You would be managing their high profile programs in Virology and they need a an experienced individual, with EU trial management, ideally in phase II and III.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in London. They will offer an excellent salary and package – around £55-70K basic salary + excellent bonus + benefits.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Clinical Operations

    £55000 - £70000 per annum, Excellent package
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    Share

    Clinical Study Manager position – purely working in Oncology, could be solid tumours, haematology or advanced therapies.

    This is a great opportunity to join a World-class Biopharmaceutical company with a strong reputation, they have a wide-ranging pipeline spanning phase I-III (and late phase) and trials being run globally. They are growing and will offer excellent long-term opportunities. They are investing a huge amount in Oncology at present and we have had excellent feedback from recent placements.

    They are recruiting for a Clinical Study Manager / Clinical Trial Manager role due to growth and new studies coming up, you would be managing their high profile programs in Oncology and they need a an experienced individual, with Oncology trial management. It could be or solid tumours, haematology or in their cell & gene therapy team.

    The role is full-time, permanent and home-based initially, office-based (2 days) with flexibility when things return to normal in London. They will offer an excellent salary and package – around £55-70K basic salary + excellent bonus + benefits.

    Skills Alliance are the preferred partner for this role. Please get in touch with Mark Anderson for more details – 0207 220 6209.

  • Pre-Clinical

    £55000 - £65000 per annum, Excellent package
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    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    Skills Alliance are partnered to support a growing Biotech to hire for their Project Management / PMO team. The company work in a cutting edge area in the advanced therapies space and have won numerous awards recently for innovation, they are growing rapidly. It is a fantastic time to join and there will be great long-term opportunities.

    The role will support the PM group to deliver a range of interesting projects and it will work closely with Scientific teams. They are looking for someone at R&D PM level who has strong Pharma/Biotech experience ideally in stem cells or gene therapy – ideally experience of Agile methodologies. This is a new role due to growth and expansion.

    The role is permanent and full-time. they would like someone to be based in their Cambridge office (with flexibility to WFH 2-3 days). They will offer circa £55-65K depending on experience + bonus + benefits.

    Skills Alliance are the preferred partner to recruit this Senior Project Manager role. Please contact Mark Anderson for more info 0207 220 6209 or APPLY NOW.

  • Pre-Clinical

    £50000 - £65000 per annum, Excellent package
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    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    Skills Alliance are partnered to support a growing Biotech to hire for their Project Management team. The company are highly innovative and work in a new and exciting area in advanced therapies, they have some exciting partnerships established and are growing rapidly. It is a fanastic time to join and they have a great team in place and is working at the cutting edge of advanced therapies.

    The role will support the PMO to deliver pre-clinical development projects and work closely with the R&D team. They are looking for someone at R&D PM level who has strong Pharma/Biotech experience ideally within pre-clinical – ideally MS Project experience and a PRINCE2 or similar PM qualification would be a plus too. This is a new role due to growth and expansion.

    The role is permanent and full-time. they would like someone to go into the Oxford office when normality resumes (with flexibility to WFH 2-3 days). They will offer circa £50-65K depending on experience + bonus + benefits.

    Skills Alliance are the preferred partner to recruit this R&D Proejct Manager role. Please contact Mark Anderson for more info 0207 220 6209 or APPLY NOW.

  • Biostatistics

    36000,- im Jahr
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    Share

    Haben Sie einen beruflichen Hintergrund im Labor? Haben Sie Ihre Ausbildung (insbesondere BTA, CTA, PTA) gerade abgeschlossen? Vielleicht haben wir den nächsten Schritt in Ihrer Karriere in petto!
    Unser Kunde in Karlsruhe sucht zum nächstmöglichen Zeitpunkt Verstärkung im Labor. Bei unserem Kunden handelt es sich um einen Dienstleister in allen möglichen Laborarbeiten. Besonders spannend hierbei sind Schwerpunkte in Biopharma, Krebsforschung, Zellanalyse sowie Covid-19.

    Schauen Sie hier, ob das Tätigekeitenfeld auf Sie passen würde:

    • Pflege der Datenbank für Biostoffe und Chemikalien
    • Versorgung der Kundenlabore mit Reinstwasser
    • Betreuung der Herstellung und Abfüllungen von Lösungen
    • Lösemittelabfallentsorgung
    • Lagermanagement
    • Bestellwesen für Laborverbrauchsmaterialien eines Fachbereichs des Kunden
    • Labortätigkeiten mit Schwerpunkt im nass-chemischen Bereich
    • Do­ku­men­ta­tion nach Kun­den­vor­ga­ben der ent­spre­chen­den Test­met­ho­den

    Mit diesen Qualifikationen glänzen Sie mit Ihrer Bewerbung:

    • Hintergrund / Ausbildung in der technischen (Labor-)Assistenz, als BTA, CTA, PTA oder einer ähnlichen/gleichwertigen Ausbildung
    • Sehr gute MS-Office Kenntnisse
    • Deutsche Sprachkenntnisse sind von Vorteil, Englisch erwünscht
    • Kundenorientierte Arbeitsweise, Teamfähigkeit, hohe Selbstmotivation

    Im Gegenzug bietet Ihnen unser Kunde:

    • Ein moderner Standpunkt mit neusten Geräten und teamorientierter Arbeit
    • Eine marktkonforme Vergütung
    • Tätigkeiten mit Eigenverwantwortung und Selbsttändigkeit
    • Eine Professionelle Einarbeitung

    Sind Sie das neue Mitglied für dieses innovative Unternehmen mit jungem Team?

    Melden Sie sich gerne mit Ihren Rückfragen oder mit Ihrer direkten Bewerbung bei:

    Fritz Köster
    +49 69 955 654
    fritz.koester@skillsalliance.com

  • Sales & Marketing

    Competitive
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    Zeit für einen Tapetenwechsel?

    Aktuell suchen wir für einen Kunden mit Sitz im Raum Düsselsdorf einen Account Manager (m/w/d) für die Region Bayern. Das internationale Großunternehmen Unternehmen ist seit 70 Jahren am Markt etabliert, bietet eine familiäre Atmosphäre und fokussiert sich auf die Entwicklung und Herstellung von Arzneimitteltherapien.

    Das sind Ihre Aufgaben:

    • Generierung und Bearbeitung von Leads, Pflege und Entwicklung von Vertriebskontakten
    • Pflege von Kundenbeziehungen, sowie die fachliche Beratung von Kunden
    • Erstellen und Bereitstellen von Prognosen für die Region Bayern zur Erreichung der KPIs
    • Enge Zusammenarbeit mit dem Account Management und dem Key Account Team zur Entwicklung kundenspezifischer Strategien zum Verkauf der eigenen Produkte
    • Eigenständige Sales Cycle Verwaltung vom Erstkontakt bis zum Abschluss
    • Kundendatenpflege im CRM-System
    • Umfangreiche Reisetätigkeit

    Das bringen Sie mit:

    • Abgeschlossenes Studium (B.Sc./ B.A.) im Bereich der Naturwissenschaften, eine kaufmännische Ausbildung oder gleichwertiger Abschluss
    • Mindestens 2 Jahre Berufserfahrung mit Kundenkontakt, vorzugsweise im biowissenschaftlichen Umfeld
    • Sehr gute Deutschkenntnisse und gute Englischkenntnisse in Wort und Schrift
    • Gute EDV-Kenntniss, sicherer Umgang mit MS Office Anwendungen
    • Führerschein Klasse B
    • Reisebereitschaft (mindestens 50%)
    • ausgezeichnete Kommunikations- und Präsentationsfähigkeiten
    • Teamfähigkeit

    Falls Ihr Interesse geweckt wurde, kontaktieren Sie Luis Freitag per Mail unter luis.freitag@skillsalliance.com oder telefonisch unter +496950988657.

  • Sales & Marketing

    Competitive
    Apply

    Job
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    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Zeit für einen Tapetenwechsel?

    Aktuell suchen wir für einen Kunden mit Sitz im Raum Düsselsdorf einen Account Manager (m/w/d) für die Region Österreich/Ungarn. Das internationale Großunternehmen Unternehmen ist seit 70 Jahren am Markt etabliert, bietet eine familiäre Atmosphäre und fokussiert sich auf die Entwicklung und Herstellung von Arzneimitteltherapien.

    Das sind Ihre Aufgaben:

    • Generierung und Bearbeitung von Leads, Pflege und Entwicklung von Vertriebskontakten
    • Pflege von Kundenbeziehungen, sowie die fachliche Beratung von Kunden
    • Erstellen und Bereitstellen von Prognosen für die Region Österreich/Ungarn zur Erreichung der KPIs
    • Enge Zusammenarbeit mit dem Account Management und dem Key Account Team zur Entwicklung kundenspezifischer Strategien zum Verkauf der eigenen Produkte
    • Eigenständige Sales Cycle Verwaltung vom Erstkontakt bis zum Abschluss
    • Kundendatenpflege im CRM-System
    • Umfangreiche Reisetätigkeit

    Das bringen Sie mit:

    • Abgeschlossenes Studium (B.Sc./ B.A.) im Bereich der Naturwissenschaften, eine kaufmännische Ausbildung oder gleichwertiger Abschluss
    • Mindestens 2 Jahre Berufserfahrung mit Kundenkontakt, vorzugsweise im biowissenschaftlichen Umfeld
    • Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift
    • Gute EDV-Kenntniss, sicherer Umgang mit MS Office Anwendungen
    • Führerschein Klasse B
    • Reisebereitschaft (mindestens 50%)
    • ausgezeichnete Kommunikations- und Präsentationsfähigkeiten
    • Teamfähigkeit

    Falls Ihr Interesse geweckt wurde, kontaktieren Sie Luis Freitag per Mail unter luis.freitag@skillsalliance.com oder telefonisch unter +496950988657.

  • Pre-Clinical

    £55000 - £65000 per annum, Excellent package
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    *PHARMA/BIOTECH EXPERIENCE REQUIRED*

    Skills Alliance are partnered to support a growing Biotech to hire for their Project Management / PMO team. The company work in a cutting edge area in the advanced therapies space and have won numerous awards recently for innovation, they are growing rapidly. It is a fantastic time to join and there will be great long-term opportunities.

    The role will support the PM group to deliver a range of interesting projects and it will work closely with Scientific teams. They are looking for someone at Senior R&D PM level who has strong Pharma/Biotech experience ideally in cell or gene therapy – ideally experience of Agile methodologies. This is a new role due to growth and expansion.

    The role is permanent and full-time. they would like someone to be based in their Cambridge office (with flexibility to WFH 2-3 days). They will offer circa £55-65K depending on experience + bonus + benefits.

    Skills Alliance are the preferred partner to recruit this Senior Project Manager role. Please contact Mark Anderson for more info 0207 220 6209 or APPLY NOW.