QA Manager (m/f/d)

Überblick:
• Startdatum: Ab sofort - spätester Beginn August 2024
• Projektdauer: bis November 2025
• Volumen: 40h/Woche
• Standort (vor Ort oder remote): Hybrid
• Sprachkentnisse: Deutsch, Englisch

Tasks:
• Acts as a delegate of the Swiss RP for IMPs
• Has the QA responsibility for GMP compliance of manufacture and analysis of IMP batches (in particular
parenteral drug product batches).
• Reviews and approves GMP procedures, records and reports (e.g. SOPs, master batch records, discrepancy and
change records and validation reports).
• Performs self-inspections in GMP plants and laboratories

Experience:
• BS/MS/PhD Degree in Pharmacy, Biology, Biochemistry, Chemistry, Life Science or equivalent
• Min. 3 years experience in activities around parenteral manufacturing and quality control
• Min. 3 years experience in a GMP regulated environment
• Experience in Discrepancy Management, CAPA, Technical Change Management (Veeva Vault) and Manufacturing Management (SAP), MES (PMX) and LIMS is an additional plus