QA Specialist (BBBH286586) Genève, Suisse
The position
The QA Specialist is responsible for the quality oversight of pharmaceutical products during distribution. This responsibility starts with the process validation phase and lasts along the product life-cycle.
Your tasks / duties
- Be involved in process validation
- Prepare and coordinate product launches
- Review and approve batch documentation records and related GMP documents
- Ensure quality oversight of the day-to-day operations at contract manufacturers and distribution centers as per GMP and GDP guidelines
- Follow all quality processes according to established procedures such as change controls, deviations, complaints, investigations, CAPA plan
- Follow and review stability studies and Product Quality Review from contract manufacturers
- Participate to the qualification of suppliers and subcontractors, including performance of external audits
- Implement Quality Agreements with the clients
- Support alert and batch recall process
- Support the implementation and maintenance of quality systems, including the preparation of quality management reviews and audits (inspections and internal audits)
Your Profile
- Scientific university degree
- At least 5 years of experience in Quality Assurance in pharmaceutical industry
- Previous experience working in close collaboration with other departments and/or subcontractors
- Strong Knowledge of GDP/GMP regulations
- Fluent in English and French, both written and spoken
Your contact at Kelly Scientific
Sophie Darthenay
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Consultant Professional Staffing Life Science