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QA Gmp Audit Manager
vor 2 Monaten
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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