Quality Manager, Teamleader QA

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  1. Contract
  2. English
  3. Mid-Senior level
  4. Research & Development
  5. Basel
  6. Healthcare & Life Sciences
  7. Quality, QA, QC, cGMP, Regulatory Compliance
This vacancy has now expired
For our client, one of the leading Healthcare & Life Sciences companies based in Basel, Swisslinx is seeking a highly motivated individual to take on a challenging role as a Quality Manager, Teamleader QA.

Job Title: Project Quality Manager
Duration: 12 months

Your mission:
- Management of Change Controls (Agile)
- Review and approval of transfer protocols
- Support of supplier qualification/certification
- Preparation and alignment of Quality Assurance Agreement (QAA)
- Review and approval of Master Batch Records, validation protocols & reports, Quality Risk Assessments, Testing Monographs etc.
- Supporting Supplier Audits and Following up on Audit CAPA activities
- Management of Deviations / OOS results (TrackWise/AQWA)
- Assuring cGMP compliance of DS manufacturing, testing and release
- Regulatory Compliance checks
- Review and approval of registration modules as required for submissions (Subway)
- Generation of responses to Health Authority queries
- Site visits if required
- Preparation of APR / PQR

The ideal candidate:
- Bachelor or higher degree in Biochemistry, Chemistry, Microbiology or other related science
- Minimum 3 years of experience in in the pharmaceutical industry
- Minimum 3 years of experience in operational quality assurance
- Good knowledge of cGMP requirements for major regulated markets (EU, US)
- Project work experience required
- Experience with IT tools like Trackwise (AQWA), Subway, Agile desirable
- Fluent in English -spoken and written

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