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Msat validation specialist 80-100%

Lalden
Lonza
Inserat online seit: 13 Juni
Beschreibung

The actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. The site is growing and for our Bioconjugates organization, we are currently looking for MSAT Process Validation Specialist (%). In this role, you will be responsible for manufacturing process validation in the biopharmaceutical plants, including process characterization, validation activities at scale and Product Quality Reviews (PQRs). Are you ready to join this outstanding team? Apply now! Key responsibilities: Prepare validation documents (study design / writing protocols and reports) according to Lonza procedure and in compliance with regulatory guidance. Own the process validation including communication with customers. Review and approving of process characterization documents. Responsible for the validation assessment on changes and deviations (approval of deviation and changes). Prepare and maintain a documented continued process verification plan. Authoring, assessing and approving of PQRs Key requirements: Master or Ph.D in Chemistry, Biotechnology, Life Sciences or related field, or equivalent experience Experience in project management, preferable in MSAT, Operation, Quality and Compliance. Experience in interaction with different teams within an organization and with regulatory agencies (Swissmedic, FDA etc.) would be an advantage. Ability to work on different tasks simultaneously and in a timely manner. 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. jid3dc1737a jit0624a jiy25a

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