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QA Manager
vor 2 Wochen
**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 **Schaffhausen, Switzerland.**
**Main 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 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.
