Senior Quality Manager
vor 1 Woche
This Senior Quality Manager position plays a key role in ensuring the highest quality standards are met at our OSD drug product manufacturing site in Switzerland. The successful candidate will be responsible for managing method transfer/verification, analytical & microbiological testing of incoming materials and packaging components, in-process testing, drug product & drug substance release testing, and stability testing.
Responsibilities:- Responsible for project management to ensure on-time and high-quality execution of analytical activities, including method transfer/verification and all testing, in compliance with the site's Quality Management Systems (QMS) & cGMPs.
- Accountable for meeting customers' expectations and needs.
- Responsible for leading OOX results laboratory investigation and deviation investigation, perform impact assessment and establish corrective actions & preventive actions (CAPA) based on the root causes.
- Responsible for reviewing and approving quality events (deviations, CAPA actions, OOX, CCR...).
- Accountable for optimizing QC processes, including procedures and daily operations to reduce lab errors and increase efficiency.
- Accountable for overseeing the daily management of the Quality Control team (planning, communication, team organization, control & feedback).
- Represent QC during client visits, audits, regulatory inspections, and health authority audits.
- University studies in chemistry, biochemistry, biology, or pharmacy or equivalent.
- 10 years' experience in QC laboratory management, CMO advantageous.
- Fluent in French and English.
- Able to work autonomously.
- Solid knowledge of analytical technologies and laboratory workflows.
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Senior Quality Systems Expert
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vor 1 Woche
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