Imp Quality Manager

vor 2 Wochen

Basel, Schweiz Itech Consult AG Vollzeit

**IMP Quality Manager (M/F/d) - pharmaceutical / cGMP/ SOPs, master batch records, discrepancy and change records and validation reports / parenteral IMPs (e.g. EU Annex 1) / CAPA/ Veeva Vault/ SAP/ MES/ LIMs / English / German**

**Project**:
For our customer a big pharmaceutical company in Basel we are looking for IMP Quality Manager (M/F/d).

Background:
IMP Quality Operations Switzerland is responsible for delivering Investigational Medicinal Products („IMPs“) to our patients in compliance with cGMP. We are the Quality Partner for all Manufacturing Units and Clinical Packaging in Pharmaceutical Technical Development in Switzerland and responsible for the Quality and Compliance oversight of all.

**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.
- Reports directly to the RP and RP deputy..

**Must Haves**:

- Bachelor or Master Degree in Life Sciences or equivalent.
- Min. 3 years of relevant experience in the pharmaceutical industry.
- Min. 3 years experience in a GMP regulated environment.
- Min. 3 years experience all activities around parenteral manufacturing and quality control.
- Demonstrated experience in a Pharmaceutical Technical Development environment.
- Knowledge of cGMP and Quality requirements for clinical development stages of biotechnological and/or parenteral IMPs (e.g. EU Annex 1).
- Experience in Discrepancy Management, CAPA, Technical Change Management (Veeva Vault) and Manufacturing Management (SAP), MES (PMX) and LIMS is an additional plus.
- Ability to communicate clearly and professionally both verbally and in writing in English (C1) as well as in German (C1).

**Soft skills**:

- 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

**Reference Nr.: 924250SDA**
**Role**: IMP Quality Manager (M/F/d)
**Industrie**: Pharma
**Workplace**: Basel
**Pensum**: 80-100% (Home Office 20 %)
**Start**: 01.07.2025 ( latest Start Date: 1.09.25)
**Duration**: 12 ++
**Deadline**: 17/06/2025

**Job Type**: 80-100%

Work Location: On the road

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