Quality Assurance Expert Manufacturing (80 - 100%)

Switzerland, Stein

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.

For Drug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch, located in Basel, Switzerland and Stein, Switzerland, we have exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as Quality Assurance Expert Manufacturing.

Key responsibilities:

  • Perform batch release for aseptic manufactured drug product

  • Write, review and approve deliverables (e.g. procedures, SOPs, cleaning documents, gap assessments) and related data bases (e.g. training, validation) to ensure GMP compliance

  • Ensure corresponding elements of the corporate Lonza GMP Quality Manual are appropriately implemented and followed

  • Document review and approval including documents in electronic systems like MES (e.g. batch records)

  • Consult line functions concerning product and process related topics.

  • Approve change requests, deviation and CAPAs related to product and process

  • Promote and enforce compliance to internal and external guidelines regarding quality and safety

  • Assure that the required level of knowledge and skills is available and identify competency gaps

  • Lead activities like development/evaluation of new tools, processes, quality initiatives, quality plans, training activities

  • Support project management functions as sub-team member or in preparation for registrations

  • Provide support to Sterile Production Stein line functions in GMP compliance related issues

Key requirements:

  • Academic degree (Master or higher) in Natural Sciences, Pharmaceutical Sciences or related field

  • Extensive working experience in Quality Assurance in pharmaceutical industry and GMP environment

  • Profound knowledge in aseptic manufacturing of chemical and biological drug products

  • Sound knowledge of written and spoken German and English is required, French is of advantage

  • Excellent communication, decision making skills

  • Ability to provide solutions for complex challenges

  • Experience in electronic batch record system is an advantage

  • Shop-Floor QA experience in 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: R26652