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QA Manager
Vor 3 Tagen
**Beschreibung**:
For our international medical partner, F. Hoffmann-La Roche Ltd. in Basel, we are looking for a qualified and motivated **QA Manager** for a temporary contract of 18 months.
**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 at Roche Basel
**Must Haves**:
- 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
- Fluent in German and English min. B1
- Fast learner, strong team player with a high level of self-motivation and with ability to prioritize, simplify and connect the dots
- Proven ability to work independently and in a team towards results, excellent planning and organizing skills in order to manage multiple tasks at the same time as well as analytical capabilities and an innovative manner of solving problems
**Nice to have**:
- Project management skills
- Proficient contribution to health authority inspections and internal GMP audits
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