QA Manager Dp
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.
You will represent Drug Product Services Visp in cross-functional teams, establish and maintain interfaces with customers, project management and technology transfer and act as a QA contact for specific projects and New-Product-Introduction (NPI).
**Key responsibilities**:
- Act as QA point of contact for specific projects and realize the interface for Deviations, Changes and product release with the customer
- Review and release product specific documentation such as process descriptions and workflows, recipes, manufacturing protocols, transfer documents, test plans, parameter lists, etc
- Establish the release file / technical release for customer batches within Module D and coordinate the release according to the associated lead times
- Establish Quality Agreements (QAA) in close collaboration with Drug Product Services DPS in Basel / Stein and LONZA Drug Substance (DS) sites
- Organize customer audits and authority inspections together with the Visp Compliance team and DPS Basel functions
- Support QA Operations activities such as quality oversight during Media Fills, assess and review of deviations, changes, CAPAs and investigations
- Support continuous improvement programs to establish an effective Quality Management System for Visp DPS
**Key requirements**:
- Master of Science or equivalent in pharmacy, chemistry, biology, biotechnology or a related field
- Highly experienced in Quality Assurance as well as customer interactions
- Experiences in a CMO environment is an advantage
- Ability to interface and communicate directly with customers
- Excellent written and oral communication in English; German language 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.
**Reference: R53788**:
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