Lead Qc Equipment Qualification Dps Growth Project
vor 1 Monat
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:
- Lead and establish analytical infrastructure services for biologics, small molecule and peptide commercial Drug Products in frame of project ramp-up for a new commercial Drug Product facility
- Liaise with partner units within the Lonza DP network as well as external partners to ensure on-time delivery of project milestones
- Review and approve documentation (installation/qualification plans and reports) related to laboratory systems as required, following applicable SOPs and all current documentation practices
- Ensure compliance of laboratory systems according to cGMP and current best practices and regulatory guidelines as well as respective SOP's
- Authoring of cGMP documents e.g. procedures (SOPs) or source documents
- Oversight and guidance for proper maintenance of equipment
- Participate as Subject Matter Expert in audits and inspections
Key requirements:
- Academical degree or apprenticeship in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field
- Significant experience in pharmaceutical industries and cGMP controlled environment
- Broad know-how and understanding of current requirements / standards related to instrument qualification and corresponding documentation
- Experience in analytical methodologies like e.g. HPLC, ICief, UV-VIS, Elisa, CE-SDS etc.
- Experience in method transfers and method validation would be a plus
- Fluency in written and spoken English, German is an asset
- Knowledge of lab quality systems like LIMS, Tiamo or Empower/Chromeleon
- Capability to work independently and in a dynamic & fast-pacing project environment
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: R51926**:
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