IMP Quality Manager – 6531
We are currently looking for anIMP Quality Manager – 6531 for an initial 1-year contract, with potential extension,to bebased inBasel/Kaiseraugst,Switzerland.
This position within IMP Quality Operations Switzerland requests a high level of flexibility, ability to work under pressure and sense of responsibility. If you have detailed knowledge of GMPs as well as outstanding interpersonal and negotiating skills, you should apply for this job.
The perfect candidate has a solid Quality Assurance knowledge and experience in GMP compliance for sterile drug product manufacturing and quality control.
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:
* 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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