QA Gmp Audit Manager
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.
Our site in Visp, Switzerland is growing and for our Biologics organization, we are currently looking for a QA GMP Audit Manager. The QA GMP Audit Manager is responsible for the planning, hosting, execution and documentation of all customer audits and for the management of internal audits (self-inspections). The manager must be able to host inspections by regulatory authorities and related follow up.
Key responsibilities:
- Preparing the annual internal audit plan based on risk
- Managing the audit / inspection process in TrackWise
- Execution of internal audits
- Preparing the annual internal audit report
- Leading the inspection readiness, organizing preparation meetings with SMEs and identifying gaps and remediation
- Hosting customer audits and health authority inspections
- Answering queries from regulatory authorities with respect to paper inspections
Key requirements:
- Master’s degree in Biotechnology, Biology, Chemistry or other natural science
- Significant auditing experience in the GMP regulated pharmaceutical industry, having an auditor certification is an asset
- Understanding of the applicable cGMP regulations
- General knowledge of manufacturing processes and quality control processes
- Experience handling stakeholder on different level and function, as well as ability to establish and maintain excellent working relationships
- Fluency in German and English (written and spoken) are both mandatory
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: R53652**:
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