(Senior) Quality Assurance Expert Primary Packaging and Raw Materials 80-100% (m/f/d)

Switzerland, Stein

Today, 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.

For Drug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch, located in Stein, Switzerland and Basel, Switzerland we have an exciting opportunity. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and be responsible to provide quality oversight to commercial testing activities by applying for the position as (Senior) Quality Assurance Expert Primary Packaging and Raw Materials

Key responsibilities:

  • Validation of methods for testing of packaging materials/raw materials

  • Ensure GMP compliance in the life cycle of packaging materials/raw materials from manufacturing to release

  • Review and final approval of packaging and raw material related SOPs

  • Act as primary point of contact for packaging materials/raw materials compliance issues

  • Approval/rejection of analytical Quality control tests and

  • Manage deviations and changes

  • Participate in audits and inspections

Key requirements:

  • Academic degree (Bachelor or higher) in Chemistry, Biochemistry, Pharmaceutical Sciences or related field

  • Significant working experience in quality assurance, preferably in aseptic manufacturing equipment/ clean utilities/HVAC

  • Good working knowledge in EU and US GMP regulations relevant for audit/inspections, qualification/validation, compliance systems

  • profound knowledge in compliance systems for document life cycle and deviation/change management, preferably experience with LIMS

  • Sound knowledge in analytical testing of raw materials  

  • Excellent communication and decision-making skills

  • Fluency in written and spoken English

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: R56501