QA Specialist: GMP & IMP Documentation Expert

Flexsis; Allschwil; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Flexsis is seeking a QA Specialist to provide operational QA support for IMPs, emphasizing documentation review, QA systems, and collaboration with CMOs to maintain inspection-ready QA operations.

The role requires a Life Sciences or related degree and 1–3 years in QA/QC or pharma manufacturing, with strong GMP knowledge and attention to detail. English is essential, German/French a plus, and eDMS/SAP experience is preferred.

Qualifikationen

• Bachelor’s degree in Life Sciences, Pharmacy or related discipline.
• 1–3 years of QA, QC, or pharmaceutical manufacturing experience.
• Practical knowledge of (c)GMP/GDP principles.
• Hands-on GMP documentation review (batch records, deviations, change controls).
• Strong organizational skills and ability to manage multiple priorities.
• High attention to detail and a structured, process-driven mindset.
• English proficiency; German or French a plus.

Aufgaben

• Batch documentation & release support.
• Perform completeness checks of batch documentation for IMPs.
• Review executed batch records from CMOs for GMP compliance.
• Identify, document, and elevate discrepancies and support their resolution.
• Prepare and compile batch documentation packages to support QA release.
• eDMS and ERP support; ensure accuracy of QA records in ERP.
• Maintain trackers for batch documentation and quality events; ensure transparency.
• Ensure documentation/records are inspection-ready at all times.
• Support intake, logging, and tracking of quality events and change controls.
• Coordinate with internal stakeholders and CMOs to ensure timely progression and closure.

Kenntnisse

QA

GMP/GDP knowledge

Documentation review

Batch records review

Change controls

Quality systems

Attention to detail

Ausbildung

Bachelor’s degree in Life Sciences/Pharmacy or related discipline

Tools

Veeva Vault (eDMS)

SAP ERP

Jobbeschreibung

Flexsis is seeking a QA Specialist to provide operational QA support for IMPs, emphasizing documentation review, QA systems, and collaboration with CMOs to maintain inspection-ready QA operations.

The role requires a Life Sciences or related degree and 1–3 years in QA/QC or pharma manufacturing, with strong GMP knowledge and attention to detail. English is essential, German/French a plus, and eDMS/SAP experience is preferred.