QA Manager

vor 3 Wochen

Basel, Schweiz Flexsis Vollzeit

**EINFÜHRUNG**:
As a preferred supplier for Roche Basel, we are looking for an individual as

**QA Manager**:
(contract until November 2025, with possible extension). The earliest start date is within 3 months. Home Office: max. 20% possible.

**AUFGABENBESCHREIBUNG**:

- 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.

**ERFORDERLICHES PROFIL**:

- 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 Haves**:

- Project management skills
- Proficient contribution to health authority inspections and internal GMP audits

**Application process**:
Interested? You can find more information here:

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