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QA Manager
vor 3 Wochen
**QA Manager (f/m/d) - parenteral manufacturing /quality control /GMP / Text Analytics / Discrepancy Management/ CAPA/ Technical Change Management (Veeva Vault) /SAP/ MES (PMX) /LIMS / German & English**
**Project**:
For our customer a big pharmaceutical company in Basel we are looking for a QA Manager.
**Background**:
**Tasks & Responsibilities**:
- 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 Haves**:
- Project management skills
- Proficient contribution to health authority inspections and internal GMP audit
**Reference Nr**.: 923301SDA
**Role**: QA Manager
**Industrie**: Pharma
**Workplace**: Basel
**Pensum**: : 80-100% (max 20% home office)
**Start** : ASAP (latest start date: 01.08.2024)
**Duration**: 18++
**Deadline**: 21.03.2024
If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.
About us:
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