QA Gmp Audit Manager

vor 2 Monaten


Basel, Schweiz Coopers Group AG Vollzeit

QA GMP Audit Manager

Key responsibilities:

- Preparing the annual internal audit plan based on risk
- Managing the audit / inspection process in TrackWise
- Execution of internal audits
- Preparing the annual internal audit report
- Leading the inspection readiness, organizing preparation meetings with SMEs and identifying gaps and remediation
- Hosting customer audits and health authority inspections
- Answering queries from regulatory authorities with respect to paper inspections

Key requirements:

- Master’s degree in Biotechnology, Biology, Chemistry or other natural science
- Significant auditing experience in the GMP regulated pharmaceutical industry, having an auditor certification is an asset
- Understanding of the applicable cGMP regulations
- General knowledge of manufacturing processes and quality control processes
- Experience handling stakeholder on different level and function, as well as ability to establish and maintain excellent working relationships

Sounds like a great job?


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