Quality Assurance Expert Devices and Packaging Materials

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 Devices and Packaging Materials.

Key responsibilities:

  • Establish and maintain equipment qualification and process validation according to GMP
  • Act as first contact for qualification, maintenance/validation within QA, document life cycle management and compliance issues in shared systems (e.g. COMOS, SAP, Unifier, DMS, Trackwise)
  • Review and approve qualification/validation protocols and reports (revalidation, verification, product transfers, cleaning validation) including associated risk assessments and deviations
  • Track GMP status of equipment/instruments/computerized-systems validated processes
  • Supervise and execute compliance activities like GMP status and trending of equipment qualification/re-qualification in relation to supplier qualification, changes, non-conformities, CAPAS, audit/inspection, document management, vendor change notification
  • Support qualification and validation activities related to routine manufacturing and launch projects
  • Ensure proper qualification of staff and of supplier/service agreements
  • Maintain relevant SOPs and support GMP training
  • Perform Quality risk assessments in case of critical deviations and initiate escalation processes
  • Support inspections by Health Authorities, customer audits, self-inspections, etc.

Key requirements:

  • Technical or academic degree (bachelor or higher) in Chemistry, Biology, Pharmacy or equivalent
  • Significant experience in Quality Control/Quality Assurance or in the aseptic manufacturing of pharmaceutical drug products and biotechnology
  • Sound knowledge of EU and US GMP regulations and ISO standards for aseptic manufacturing
  • Good know-how in current pharmacopoeia requirements incl. technical methods
  • Sound knowledge of written and spoken English and German
  • Excellent ability to provide solutions for complex challenges
  • Assumes responsibility and sets clear priorities to reach common goals

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: R23649