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水平: Mid-Senior level
工作类型: Full-time
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工作内容
For IBEX Solutions (www.ibex.lonza.com), our recently launched unique biological manufacturing and development concept in Visp, Switzerland, we have multiple openings. Become part of this exciting opportunity and join our team by applying for the position as Junior QA Manager Batch Record Review for the IBEX Solutions facilities.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
- 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.
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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最后期限: 09-06-2024
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