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Quality Technology QA Manager
QA CTM GxP audit
JobCLS Services is a leading professional recruitment agency specialised in chemistry & life sciences.
For our client Astellas Pharma Europe B.V. we are searching for a Quality Technology QA Manager.
- Clinical Trial Material
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.
ProfileThe ideal candidate has a Master degree with several years of experience in a similar role. You have experience with audits and inspection readiness.
Days of leave: 25 + 13
See here our other employment terms for this vacancy