IMP Quality Manager (m/f/d)

Hays; Basel; Vor Ort; CHF 100’000 - 130’000; Vollzeit

Zusammenfassung

A leading company in the Pharmaceutical industry is seeking an IMP Quality Manager for a 12-month contract in Basel. The ideal candidate will have extensive knowledge in Quality Assurance and GMP compliance for sterile drug products, with roles including oversight of GMP practices and quality control assessments. Applicants must have a degree in Life Sciences and at least 3 years' experience in a GMP-regulated environment, as well as strong English and German communication skills.

Qualifikationen

• Minimum 3 years' experience in pharmaceutical industry and GMP regulated environment.
• Experience in parenteral manufacturing and quality control.
• Proficient communication skills in English (C1) and German (C1).

Aufgaben

• Responsible for GMP compliance and approval of procedures, records, and reports.
• Conducts self-inspections at GMP plants and laboratories.
• Acts as a delegate for Swiss RP for IMPs.

Kenntnisse

Quality Assurance

GMP compliance

Discrepancy Management

CAPA

Technical Change Management

Manufacturing Management

Ausbildung

Bachelor or Master Degree in Life Sciences

Tools

Veeva Vault

SAP

PMX

LIMS

Jobbeschreibung

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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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