QA Manager Ebr
Vor 3 Tagen
Switzerland, VispToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Key responsibilities:
- Execute and ensure GMP compliance according to established quality standards and GMP regulations
- QA Responsible for master batch records.
- Manage, improve and optimize documentation, batch record review process.
- Managing the review and approval of executed electronic batch records (eBRs), for consistency with approval documents, process descriptions, transfer documents, test plans, parameter lists etc.
- Review of manufacturing and batch record-related SOPs.
- Quality oversight of the automated process landscape.
- Be the point of contact for batch records quality-related questions and resolve issues originating from manufacturing operations.
- Ensure a continuous liaison with Batch Record Review team and Operations to meet deadlines and ensure a timely batch disposition execution.
Key requirements:
- BSc. in IT, Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent.
- Working experience in Quality Assurance/manufacturing/Quality Control/IT, ideally in the pharmaceutical industry.
- Experience in QA batch documentation review process is preferable.
- Experience with automated manufacturing systems, e.g. Syncade MES is desired.
- Knowledge of EU and US GMP regulations.
- Strong affinity to automation and IT.
- Fluency in English, able to communicate in or willing to learn German.
Every day, 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.
**Reference: R52420**:
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