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Quality Technology QA Manager

Vacaturenummer: A2100210
Astellas Pharma Europe B.V. - Leiden (Nederland)

For our client, Astellas Pharma Europe B.V., we are looking for a Quality Technology QA Manager.

Keywords

  • QA
  • Clinical Trial Material
  • GxP


Profile
As Quality Technology QA Manager, you are responsible for supporting management of local release of Clinical Trial Material (CTM) products to support both regional and global clinical studies. Additionally, you are responsible for the execution of all QA activities to support these products, including GDP oversight, CTM Product Complaint handling, and CMO QA management, Supplier Evaluation Program, under development stage. Finally, you will be responsible for supporting QA oversight of activities for preparation for product launch of new Astellas Commercial Products.

You will manage and execute key day to day CTM QA activities under development stage as follows:
  • Contribute to any type of development project and execute overall quality assurance activities under development stage;
  • Execute CTM release for clinical studies or support the QA responsible person / Qualified Person (QP) for CTM release;
  • Support the secretariat role for Risk Evaluation Committee (REC) for CTM;
  • Preparation and co-ordination of specific technical QA guideline/SOP and/or policy documents under development and commercialisation stages;
  • Contribute to global CTM QA Meeting;
  • CTM Product Master File review and support to approval for global supply;
  • Assessment of CTM facility design to be built for Global GMP/GDP compliance perspective;
  • Support global co-ordination of Annual CTM supplier audit;
  • Audit for CTM Supplier;
  • Evaluation for business partners such as new GMP service providers (including Due Diligence);
  • Change Evaluation and Control of CTM;
  • Complaint Handling of CTM;
  • Deviation Control of CTM;
  • Collect any relevant information on the new areas, from academia, relevant industry;
  • Support QA management review; preparation and review for performance data of GMP activities for CTM;
  • QA oversight for CMOs under development and commercialisation stages;
  • PAI (pre-approval inspection) Readiness for development product and Commercial Readiness for newly commercialised product:
  • Strategic Audit for candidate of the manufacturers (including Due Diligence activities);
  • Mock inspection and consultation for CMO inspection readiness;
  • Initiation of the commercial QA agreement;
  • Ensure the consistency between manufacturing and applied dossier;
  • Master and Executed Batch Record Review for the first product release;
  • Review of the Performance Qualification and Process/Cleaning/Analytical method Validation;
  • First Approval of Commercial Product Master Specification;
  • Development of the agreed critical quality attribute;
  • Monitoring of the Product Quality until stable manufacturing;
  • QA Knowledge transfer to Quality Operations Group.


Who we're looking for
The ideal candidate has a Master degree with several years of experience in a similar role. You have experience with audits and inspection readiness.

Company profile
Astellas is a Japanese multinational pharmaceutical company employing over 17,000 people world-wide with global sales exceeding 11 billion euro. The group’s EMEA headquarters are based in London, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing. With over 4,500 employees, EMEA is an important and growing Astellas region, having key strengths in the therapy areas of Urology, Transplantation, Anti Infectives, Pain Management and Oncology. The global annual R&D investment of 15% to 20% of sales is evidence of the group’s commitment to improving the health of people world-wide through the provision of innovative and reliable products. Astellas employs around 950 persons in the Netherlands, in Leiden and Meppel.


Additional vacancy information
Reference:A2100210
Contract:Temporary contract with CLS Services
Education:WO/MSc.
Employment terms:Salary: >4000
Days of leave: 25 + 13
See here our other employment terms for this vacancy
Publication date:11-10-2021
Location:View location with Google Maps
Contactperson:Aniek Vugts
+31 (0)88 22 77 555

CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.