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Quality Control Manager
Location: Zurich Oerlikon
Workload: 80 to 100%
Start Date: ASAP
We are supporting a well established Swiss pharmaceutical company headquartered in Zurich in the search for a Manager, Quality Control Management. This role is a key position within the QC team and combines operational leadership with strategic responsibility in a GMP regulated environment.
The successful candidate will ensure compliant and efficient quality control operations while driving continuous improvement, digitalization, and regulatory excellence.
Responsibilities
- Lead and further develop the stability program from both an operational and strategic perspective
- Ensure timely and GMP compliant release of bulk and finished products, including scientific evaluation of analytical results
- Plan, coordinate, and monitor maintenance, qualification, and validation activities within Quality Control
- Create, review, and continuously improve specifications, analytical procedures, and SOPs
- Lead and manage deviations, CAPAs, and change control processes in collaboration with QA and laboratory teams
- Prepare, support, and follow up on internal and external audits and regulatory inspections
- Ensure ongoing regulatory compliance in line with current guidelines and pharmacopoeia updates
- Act as the technical expert for analytical troubleshooting, particularly in HPLC
- Contribute strategically to method development, validation, and optimization of analytical processes
- Develop, program, document, and validate Excel based tools including macros and VBA applications within a GMP framework
- Ensure data integrity in accordance with ALCOA+ principles and actively drive digital enhancement of QC processes
Requirements
- University degree in Analytical Chemistry, Pharmacy, or equivalent scientific education with further specialization
- Several years of experience in Quality Control or analytical development laboratories under GMP conditions
- Strong hands on expertise in HPLC analytics and data evaluation
- Experience with Empower or comparable chromatography data systems
- Proven experience in validation of analytical methods and computerized systems is an advantage
- Solid experience in developing and validating Excel based tools in a regulated environment
- In depth understanding of GMP regulations and data integrity requirements
- Fluent German and good English skills