QA Manager, Contamination Prevention
vor 2 Monaten
Switzerland, VispToday, 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.
For our biggest site in Visp, Switzerland we are looking for a QA Manager, Contamination Prevention & Control (f/m/d), who will support the end-to-end contamination control strategies within our Biologics Business Units.
Key responsibilities:
- Develop and implement a comprehensive, end-to-end contamination control strategy for large-scale mammalian, and other Biologics GMP programs
- Ensure facility and quality systems state of compliance with internal requirements, appropriate regulations and participate in the development of action plans to correct deficiencies and assure the adequate microbiological quality of the site facilities, utilities, processes, and products
- Collaborate with cross-functional teams to ensure contamination prevention and control requirements are met for new product introductions, facility adaptations, and process changes
- Lead and guide Investigations of contamination incidents and deviations from contamination control procedures
- Provide microbiological expertise to support Investigations, CAPAs and Change Control related to Contamination Prevention and Control
- Develop and deliver training programs to facility staff on contamination prevention and control, cleanroom behavior, and hygiene best-practices
Key requirements:
- Bachelor's degree in a relevant scientific discipline, preferable in microbiology
- Substantial GMP experience in the biologics industry, with direct QA or directly relevant QC Microbiology experience
- Strong knowledge of contamination control principles, practices, and regulations (e.g. FDA, EMA)
- Working knowledge of microbiological testing methods, media challenges, environmental monitoring, clean room qualification and management, and microbiological control strategy required
- Fluency in English, 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.
**Reference: R54714**:
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