QA Manager – C&Q Compliance – 5383 (ADA)
Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for an experienced Quality Assurance Manager responsible for the Commissioning & Qualification (C&Q) Compliance of an aseptic fill-finish drug product manufacturing facility CAPEX project in Visp, Switzerland.
· Responsible for the quality oversight and regulatory aspects of the assigned CAPEX project
· Ensuring C&Q compliance of GMP systems related to the aseptic fill-finish 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
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required.
- Bachelor or Master's degree in Engineering, Life Sciences or related field
- 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 fill-finish processes and facility (filling equipment, lyophilization, clean utilities, and clean room facilities.
- Fluent in English, German would be an advantage.