Contamination Control and Cleaning, Senior QA Specialist 80–100% (f/m/d)
Vollzeit @Lonza veröffentlicht 23 Stunden agoJob-Beschreibung
Location: Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.
T oday, 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 (f/m/d) for Large Scale Mammalian in Ibex Solutions, our recently launched unique biological manufacturing and development concept. The successful candidate will be part of QA Operations and will be in direct contact with the key stakeholders C ontamination Prevention and Control group, MSAT, Operations, Hygiene etc.
What you’ll get:
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An agile career and dynamic working culture
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An inclusive and ethical workplace
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Compensation programs that recognize high performance
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A variety of benefits dependant on role and location
What you’ll do:
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Review and approve the routine cleaning-relevant documents, i.e., routine cleaning plans and reports, MAC plans and cleaning QC plans
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Ensure all cleaning related deviations are appropriately investigated and recorded, direct the investigations of customer product complaints and assure the completion of the appropriate documentation
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Be a pa rt of QA Ops working in close contact with contamination Prevention and Control group, MSAT, Ops, Hygiene etc
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Approve local procedures and ensure that they are compliant with the site Contamination Control Strategy
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Provide Quality oversight for all CCS topics limited to the facility (local CRs, DRs, and DMS documents)
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Responsible for review and final release of records like Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, Material Specifications, Deviations, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc.
What we’re looking for :
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Bachelor / Master degree in Microbiology / C hemistry / Biotechnology or any related field
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Significant experience i n contamination control in GMP regulated pharmaceutical industry; in a QA role in a Large Scale stainless steel facility is required
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General knowledge of manufacturing processes , cleaning procedures and analytical methods
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Experience with GMP management systems like TrackWise , SAP, Syncade and Microsoft suite of products is preferred
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Experience in the interaction with Health Authorities ( Swissmedic , FDA etc.) is desired
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Business fluent English is required, able to communicate in or willing to learn German
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.
