QA Expert
Vor 2 Tagen
Switzerland, Basel
Switzerland, Stein
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.
**Key responsibilities**:
- Executes, establishment and maintenance of the Pharmaceutical Quality Management System at Drug Product Services for manufacturing of sterile products including combination products
- Supports the organization in compliance topics as part of the QA Compliance team including but not limited to CAPAs, self-inspections, KPIs, assess GMP training requirements
- Assist the line functions in the creation and monitoring of quality processes related to the relevant parts of the Quality Management System for combination products
- Act as author and approve corresponding guidance documents and be first contact concerning methods, validation and testing and acting in any compliance issue for combination products
- Tracking GMP status of service providers (e.g. calibration, maintenance, consultants) tracking SAP material and supplier master data
- Active participation in audits and inspections and following up
- Act as QA representative for the packaging team by approving methods, laboratory reports and development activities
**Key requirements**:
- Academic degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences or related field
- Significant working experience in Quality Assurance in pharmaceutical industries and GMP environment preferable in sterile manufacturing
- Excellent working knowledge in EU and US GMP regulations relevant for sterile manufacturing and sound knowledge in manufacturing of combination products / ISO13485 / 21Cfr4 / MDR
- Sound knowledge in compliance systems for document life cycle management, workflow tools (e.g. Document Management System) and processes for sterile Drug Product manufacturing incl testing
- Exceptional communication skills as well as customer focus (intern/external)
- Excellent knowledge of written and spoken English, basic knowledge of German
- Open minded, self driven, independent
- Structured working attitude
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: R61580
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