A global biotechnology company is currently looking for a Quality Specialist to take charge of the QA interface with manufacturing and testing partners for assigned products/projects by ensuring the quality of product/process transfers, validations, issues investigations, tracking and resolution in a timely manner as well as process improvements. The position is full time and based in Switzerland.
- Manage the QA interface with manufacturing and testing partners for clinical and commercial products, ensure quality issues are appropriately investigated, tracked and resolved in a timely manner
- Ensure appropriate corrective and preventive actions are defined, implemented and their efficacy is evaluated
- Provide technical support for the manufacture of products at Contract Manufacturer Organisations (CMOs)
- Ensure that the CMO maintains quality systems that are in a state of compliance
- Participate in regulatory inspections and support regulatory inspections at CMOs. Perform risk assessment as preventive measure or in response to product/quality system failures, investigations and regulatory inspections. Coordinate of preparation and review of domestic and international regulatory filings
- Participate in the preparation of the annual product review, Responsible for the quality aspects related to the transfer or set-up of drug products processes to CMOs, including but not limited to risk assessment, validation protocol and report review and approval, defining and following up on quality and performance indicators.
- Minimum Bachelor’s degree, Master degree preferred, in a scientific topic (Pharma, Chemistry, Biology, Biochemistry etc.)
- A minimum of 3 years of experience in similar position in pharmaceutical or biotechnology industries
- Relevant experience in either manufacturing (packaging), development, quality or regulatory;
- Understanding of cGXPs, quality systems and regulations (FDA and EU)
This is an excellent position for a Quality Specialist who would like to develop further experience in biological medication. Candidates from EU region are welcome
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A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.