Quality Assurance Expert Manufacturing Release

vor 2 Wochen

Stein, Schweiz Lonza Vollzeit
Switzerland, SteinToday, 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:

  • Perform batch review and release for aseptic manufactured drug product
  • Write, review and approve deliverables (e.g. batch records, procedures, SOPs, cleaning documents, gap assessments) and related data bases (e.g. training, validation) to ensure GMP compliance
  • Approve change requests, deviation and CAPAs related to product and process
  • Promote and enforce compliance to internal and external guidelines regarding quality and safety
  • Ensure required level of knowledge and skills as well as identify competency gaps and solutions
  • Lead and support development and evaluation of new tools, processes, quality initiatives and plans
  • Support Sterile Production Stein line functions in GMP compliance related issues and attend related meetings on the shop floor

Key requirements:

  • Academic degree (Bachelor or higher) in Natural Sciences, Pharmaceutical Sciences or related field
- first working experience in Quality Assurance in pharmaceutical industry and GMP environment
- experience knowledge in aseptic manufacturing of chemical and/or biological drug products

  • Sound knowledge of written and spoken English, German is an asset
  • Experience in electronic batch record systems, Trackwise and DMS, Shop-Floor QA or Quality Oversight is an advantage
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:

R52220:

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