Senior QA Specialist, QA Operations
vor 1 Monat
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 Quality organization, we are currently looking for a Senior QA Specialist for Large Scale Mammalian in Ibex® Solutions, our recently launched unique biological manufacturing and development concept. The successful candidate will be responsible for QA Operations and will be in direct contact with the key stakeholders in the operations Team, QA/QC & Project Management teams within the organization.
Key responsibilities:
Act as QA Ops cleaning SME in meetings with the relevant stakeholders, and customers, in audits and inspections Reviewing and approving the routine cleaning-relevant documents, i.e., routine cleaning plans and reports, MAC plans and cleaning QC plans Owning all quality-related responsibilities for the cleaning and manufacturing processes of biopharmaceutical products and representing QA in project/tech transfer teams Responsibility for the review and final release of records like Standard Operating Procedures (SOPs), Master Batch Records, Material Specifications, Deviations, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc. Identifying emerging QA relevant topics, communicating to the relevant stakeholders and working actively on their development into new or already established Quality and Compliance strategies and/or standards i.e., CAPAs Supporting the batch disposition preparation, including recommendations on disposition status Support continuous improvement programs to establish effective Quality Management SystemsKey requirements:
Bachelor or Master's degree in chemistry, biotechnology, life science or related field Significant experience in the GMP-regulated pharmaceutical industry; preferably in a QA role is required We are looking for someone who is independent, sociable, customer focused and who values working as a team player General knowledge of manufacturing processes, cleaning procedures and analytical methods Experience with TrackWise, SAP, and Microsoft Office software is preferred Experience in the interaction with health authorities (Swissmedic, FDA etc.) is desired Fluency in English, able to communicate in or willing to learn GermanEvery 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: R60324-
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