Junior QA Manager
vor 1 Woche
The Junior QA Manager Batch Record Review IBEX reports to the QA Operations Group Leader IBEX, working in close collaboration with different quality and multiple operations functions in order to ensure cGMP-compliant manufacturing activities and documentation within IBEX.
Key responsibilities:
- Review of the Executed Batch Records (e.g. cleaning logs, production documentation review, temperature reports, test procedures, raw data, logbooks)
- 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
- Collect and evaluate on a regular basis KPI data
- Write and revise SOPs in his/her area of expertise
Key requirements:
- Bachelor, Master degree or PhD in Biology, Chemistry, Biotechnology, Life Science 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
- German: Mother tongue or very proficient; English: Fluent.
Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
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