QA Expert Equipment Qualification and Validation

vor 2 Wochen

Stein, Schweiz Lonza Vollzeit

Switzerland, SteinToday, 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 primary objective of the role is to ensure proper timing in inspection preparation for a large CAPEX project (encompassing a fill and finish facility, laboratories, warehouse, shipping and offices). The role will manage qualification and validation activities to support the projects teams and objectives according to agreed deadlines and standards. Then, after the project phase, will manage qualification and validation activities to maintain the qualified/validated status of all GMP activities necessary to maintain commercial product batch activities.

**Key responsibilities**:

- Carry out your duties and responsibilities as a QA Qualif./Valid expert. as a leader in these dedicated activities.
- Acting as Senior Quality Single Point of Contact for qualification / validation (CSV included) Projects.
- Providing Quality Oversight ensuring the compliance positioning / execution of the designed DI /CSV Strategy is accurate and following.
- Ensuring compliance of computerized systems with regulatory requirements (e.g. Annex 11, 21CFR Part 11) and best practices (e.g. GAMP 5, ASTM E2500) through eCompliance by design
- Be the owner of all tasks related to quality operations that will be assigned to him as a QA expert in Qualification/Validation and CSV/DI..
- Manage deviations associated with its activities and expertise.

Key requirements:

- Academical degree (minimum Bachelors) in in a Life Sciences, Engineering; IT Systems, Industrial Engineering or related science discipline
- Strong experience in CSV / CQV/ DI
- Significant Experience in a QA role within a GMP regulated environment
- Knowhow in aseptic Drug Product fill and finish
- CAPEX project experience
- Fluency in English, German would be an asset

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: R58833
- Apply

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