Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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 organization, we are currently looking for a Senior QA Manager Computerized Systems Validation (CSV) in Ibex® Solutions, our recently launched unique biological manufacturing and development concept.
The QA Manager Computerized Systems Validation (CSV) is ensuring that all processes for facility, equipment, utilities and systems comply with cGMP requirements and internal/external quality standards over the entire life cycle. As a Quality and Compliance representative, he/she will be a key member in cross-functional technical project teams
Become part of this exciting opportunity and apply now!
Key responsibilities:
Reviews and approves CSV / Qualification Documents (e.g. URS, FS, DS, DQ/IQ/OQ/PQ Plan and Reports, risk analyses, etc.).
Representative of QA CSV during FAT’s and Supplier Qualification Audits as SME. Willingness to travel required is required, but very limited 0-4%.
Authors and Owns the facility CSV Master Plan and associated SOPs.
Representative of QA CSV during customer audits and regulatory inspections.
Responsible for ensure Data Integrity compliance at the site
Key requirements:
Bachelor, Master Degree or PhD in Engineering, Information Technologies, Natural Sciences or related field.
More than 10 years of experience in the area of pharmaceutical manufacturing, mainly in computerized systems.
Broad knowledge of automation, engineering and manufacturing processes.
Strong team orientation.
Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive.
Languages: English required, German is an advantage.
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.