QA Process Validation Specialist (f/m/d)

Switzerland, Visp

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.

The site in Visp, Switzerland is growing and for our Biologics organization, we are currently looking for a QA Manager for Process Validation. In this role, you will be responsible for manufacturing process validation in the biopharmaceutical plants, including process characterization, validation activities at scale, continued process verification and Product Quality Reviews (PQRs).

Key responsibilities:

  • Preparation of validation documents (study design / writing protocols and reports) according to Lonza procedure and in compliance with regulatory guidance

  • Leading the process validation teams including communication with customers

  • Supporting R&D teams during the process characterization phase. Reviewing and approving of process characterization documents

  • Responsibility for the validation assessment on  changes and deviations (approval of deviation and changes)

  • Preparation and maintenance of a documented continued process verification plan

  • Assessing  and approving of Product Quality Reviews

Key requirements:

  • Master of Science degree or PhD in a life science discipline

  • First experience in GMP regulated environment

  • Ideally first experience in a similar position

  • Fluent communication in English (written and spoken), additional fluent communication in German

  • Ability to work on different tasks simultaneously and to work towards deadlines

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: R39859
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