Batch Record Reviewer
vor 1 Woche
We are currently supporting a global Bio-Pharmaceutical company in their search for an experienced QA Batch Record Reviewer to join their team in Switzerland. This is a fantastic opportunity to take ownership of technically challenging projects in a dynamic and innovative environment.
As a Batch Record Reviewer making sure the batch was made properly, according to procedure and regulatory requirements. Reviewers should have great attention to detail, be able to work independently, and have a thorough knowledge of the manufacturing process they are reviewing
**Key Responsibility**:
- Review of the Executed Batch Records (e.g. production documentation review, raw data etc)
- Support batch release by ensuring the completeness of the documentation package
- Review comments added to the Executed Batch Records, clarify with the operations team and evaluate with the responsible QA Manager
- Support the initiation of deviations and investigations for Batch Record review related observations
**Key Requirement**:
- Academic degree OR relevant work experience in Biology/ Chemistry/ Biotechnology or other related field
- Previous experience in GMP regulated pharmaceutical / API industry is an advantage
- Ability to identify non-compliance and gaps from quality standards
- Structured, precise and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive
- Fluent English (written and verbal) is required, German language skills preferred
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