IMP Quality Manager (m/f/d)

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One of our clients in the Pharmaceutical industry is looking for an IMP Quality Manager. The perfect candidate has a solid Quality Assurance knowledge and experience in GMP compliance for sterile drug product manufacturing and quality control.

General Information:

• Planned duration: 12 months (Extension: very likely)
• Workplace: Basel
• Home Office: max. 20%

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).

Nice to Have:

• Proficient contribution to health authority inspections and internal GMP audits

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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