QA Manager 80-100% - Stein, Schweiz - Lonza
Beschreibung
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.
In order to support the strategic investments of the company in Stein (Switzerland) Quality SGIE (Strategic Growth Investments & Engineering) is looking for an experienced Quality Assurance Manager (f/m/d) responsible for the Commissioning & Qualification (C&Q) compliance of an aseptic fill-finish drug product manufacturing facility CAPEX project.
Key responsibilities:
- Responsible for the quality oversight and regulatory aspects of the assigned CAPEX project
- Ensuring C&Q compliance of GMP systems related to the aseptic fillfinish facility (equipment/utilities/facilities) during the project management lifecycle from design engineering through to the initial C&Q and handover phases
- Reviewing and approving C&Q documents of GMP systems as well as related changes and deviations
- Supporting audits and regulatory inspections (Swissmedic, FDA, etc.)
- Providing leadership and guidance to project team members on C&Q strategy and issues
- Ensuring that decisions are fully supported by global and local Quality, as well as Regulatory
- Escalating issues in an open and timely manner and take leadership for their resolution
Key requirements:
- Academical degree (minimum Bachelor) in Engineering, Life Sciences or related field, or equivalent work experience
- Significant experience in the GMP regulated pharmaceutical industry, preferably in a role within a Quality Unit
- Experience in a QA role for the C&Q of GMP systems related to aseptic fillfinish processes and facility (filling equipment, lyophilization, clean utilities, and clean room facilities)
- Fluent in English, German would be an advantage
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences.
Reference:
R54157:
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