QA Expert Compliance

vor 6 Monaten

Basel, Schweiz Lonza Vollzeit

Switzerland, BaselToday, 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:

- Drafts, negotiates and finalizes Quality Agreements with Suppliers and Service Providers
- Ensures the proper qualification of material/service suppliers by supervising adherence to global QMS requirements
- Interacts with the Global Supplier Qualification team by acting as local Point of Contact for the line units of Drug Product Services in both Basel and Stein
- Supports establishment and maintenance of the Quality Management System at Drug Product Services (DPS) for QC in Basel and manufacturing plants in Stein
- Prepares, reviews and approves GMP documents such as SOPs, Work Instructions for assigned topics
- Supports customer audits and health authority inspections as required
- Acts a system coordinator at local level for systems like DMS, Trackwise, SAP

Key requirements:

- Academic degree in Chemistry, Biochemistry, Pharmaceutical Sciences or related field
- Solid working experience in Quality Assurance in pharmaceutical industries and GMP controlled environment preferable in production and/or analytics. Experience with supplier qualification is a plus.
- Very good working knowledge in EU and US GMP regulations relevant for audit/inspections, qualification/validation, compliance systems
- Sound knowledge in compliance systems for document lifecycle management, training management and workflow tools (e.g. TrackWise)
- Ability to handle complex situations successfully, and to define tasks self-reliantly after discussion with line manager
- Highly organized work style to ensure multiple assigned projects can be handled in parallel
- Very good knowledge of written and spoken English; German is a plus

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: R59609

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