For our client, an international pharmaceutical company, we are currently looking for an IMP Quality Manager.
Location: Basel
The perfect candidate has a solid Quality Assurance knowledge and experience in GMP compliance for sterile drug product manufacturing and quality control.
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).
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Pharmaceutical Manufacturing
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