QA Contamination Prevention Manager (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.
Ibex® Solutions (www.ibex.lonza.com) is a modular build complex to develop and manufacture biological products. It enables companies to get access to a complete solution, gaining speed and achieving a simplified value chain. The Ibex® Complex is our contribution to the medicine of tomorrow and possibly the next step in your career? Start your career with Lonza today. Apply as QA Contamination Prevention Manager (f/m/d)!
Ensures that an end-to-end microbial control concept is developed for the biotechnological drug substance manufacturing facilities and is captured in local documents (incl. specifications, SOPs, etc.)
Supports the Quality Oversight on the activities of the Environmental Monitoring and activities related to the assessment of disinfectants from microbiological expertise point of view
Writes, Reviews and approves SOPs, deviation reports and change requests associated with the above-mentioned topics
Supports the preparation and follow-up of customer audits and regulatory inspections; acts as an expert during audits / inspections presenting aspects related to the microbial control and sterility strategies
Enhances the quality knowledge by following the quality standards and by visiting specific training courses/conferences
University degree (Bachelor, Master or PhD) in pharmacy, engineering, chemistry, or related life sciences discipline, preferably microbiology
More than 5 years (more than 10 years preferred) of experience in the area of biopharmaceutical manufacturing
Strong background in cGMPs
Broad knowledge related to hygiene topics, environmental monitoring, disinfectant testing, microbial control strategies
Good communication skills and interaction with all kind of interfaces within the organization and with regulatory agencies (e.g. US FDA, EMA, etc.).
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.