Process Expert, Drug Product, Ibex®
Vor 2 Tagen
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.
Key responsibilities:
Act a change agent, who is supporting and promoting overall changes in Drug Product department, with a particular focus on the following activities:
- Manage Technical Change Requests (TCR) creation in SAP and implementation by leading weekly TCR meetings and following up with the relevant stakeholders
- Support the process of Maintenance notification (Störmeldung) creation in SAP and resolution by participating in weekly "Störmeldung"-meetings
- Support process and equipment related deviation investigations, CAPA implementation and CAPA effectiveness checks, as well as change requests (CR), within required timelines and through GMP systems
- Write and/or adapt department specific SOPs in the area of expertise
Key requirements:
- Bachelor's/ master's degree / PhD, preferred area of study: Pharmaceutical Technology, Biotechnology, Chemistry, Pharmacy or equivalent scientific degree
- Experience in the area of sterile drug product manufacturing is highly preferred
- Fluency in English, the knowledge of other languages is an asset, especially German
- Familiarity with GMP requirements, quality procedures and SOP execution
- Good communication skills and interaction with a variety of interfaces within the organization and on the shopfloor
- Proven IT knowledge, knowledge in Trackwise, SAP and MES are 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: R49233**:
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