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Imp quality manager

Basel
Qualitätsmanager
Inserat online seit: 1 Juli
Beschreibung

Main 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.

Qualifications and Experience:

1. Relevant Swiss working/residency permit or Swiss/EU-Citizenship required.

• 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).

• Project management skills

• Proficient contribution to health authority inspections and internal GMP audits

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