QA Expert Manufacturing 80-100%

vor 3 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.

**Key responsibilities**:

- Maintenance and execution of the Quality Oversight at the DPS manufacturing facility (aseptic manufacturing, process simulations (APS), environmental sampling, proper qualification of DPS staff in aseptic techniques)
- Review and approve protocols and reports for e.g. APS, holding time studies, cleaning studies, equipment/room qualification as applicable including documents in electronic systems like MES or DMS (e.g. SOPs) to ensure GMP compliance
- Oversee material qualification/storage/transport and material/personnel flow according to GMP regulations
- Ensure that the corresponding elements of the corporate Lonza GMP Quality Manual are appropriately implemented and followed
- Approve change requests, deviation and CAPAs related to product and process
- Support a culture of high performance and trust. Assure that the required level of knowledge and skills is available and identify competency gaps. Establish and implement training and development plans
- Lead activities like Development/evaluation of new tools, processes, quality initiatives, quality plans, training activities
- Represent Sterile Production Stein QA in inspections, audits and local and global initiatives

**Key requirements**:

- Academic degree (Bachelor or higher) in Natural Sciences, Pharmaceutical Sciences or related field
- working experience in Quality Assurance in pharmaceutical industries and GMP controlled environment preferable in sterile Drug Product production
- knowledge in aseptic manufacturing of chemical and/or biological drug products
- Sound knowledge of written and spoken German and English is required
- Shop-Floor QA experience in Quality Oversight is an advantage
- Detail oriented, precise and organized
- Willingness to learn and carry out new and complex tasks

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: R51469**:

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