Senior QA Specialist
vor 2 Wochen
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:
- Act as QA representative in Project teams and represent QA in customer meetings during Technical Transfer.
- Support and approve project / product specific documents such as process forms, manufacturing process descriptions, product specification files, transfer documents and test plans.
- Act as QA contact for specific projects and realize the interface for DRs and CRs with the customer.
- Act as point of contact for Drug Product QA related questions, topics and complaints from customers related to the manufacturing operations.
- Lead meetings with customers like quality to quality calls, technical deviation meetings and meetings connected to release activities.
- Work closely with QC-Project Leader (QC-PL) and MSAT for New-Product-Introductions (NPI) and tech transfer activities.
- Establish Quality Agreements (QAA) in close collaboration with Drug Product Services DPS in Basel / Stein and LONZA Drug Substance (DS) sites (e.g. Slough / Visp).
- Assist with preparation of release packages for technical batch release and certification done by Lonza internal RP/FvP.
Key requirements:
- Master of Science or equivalent in pharmacy, chemistry, biology, biotechnology or a related field.
- Highly experienced in Quality Assurance / Quality Control; experience in both fields is a clear advantage.
- Experience in a CMO environment is an advantage.
- Ability to interface and communicate directly with customers as well as internal stakeholders.
- Ability to prioritize work in a highly demanding and busy environment.
- Excellent written and oral communication in English, and German language or willingness to learn it is a clear 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.
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