QA Process Validation Specialist (f/m/d)
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 chemical 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 chemical plants, including process characterization, validation activities at scale, continued process verification and Product Quality Reviews (PQRs).
Preparing of validation documents (study design / writing protocols and reports)
Consistent implementation and maintenance of the Continued Process Verification (CPV) and Product Quality Review (PQR) programs at Visp
Supporting R&D teams during the process qualification phase, as well as operations assessing changes and deviations
Preparing and maintenance of a documented continued process verification strategy / documents
Reviewing, validation assessments and final approvals of PQR`s
Master degree or PHD in chemistry, chemical engineering or a related field
Significant experience in the GMP related environment
Experience working with validation protocols, validation reports and PQR`s
Working experience within a similar position as well as experience with statistics, would be an advantage
IT experience with Trackwise and Documentum would be an advantage
English and German language skills on a proficient level are required
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.