Expert, Development QA (GMP, GDP)
CK Group are recruiting for a QA Expert to join a Swiss high-potential biopharmaceutical company, specialized in the discovery, development and commercialization of innovative small molecules, with the aim of transforming the horizon of therapeutic options.
The position will be for a 12-month contract, located near at the clients office near Basel, the rate for this role will be up to 94.91 CHF per hour.
As a QA Expert, you will manage all required activities to support the release of drug substances, drug products and intermediates for development or pre-commercialized products in portfolio sent worldwide. This includes the approval of master process documentation, batch record review, resolution of investigations, and assessment of change controls in close collaboration and quality oversight of CMOs.
Requirements:
- Advanced University degree in Pharmacy, Chemistry or alternative technical/science university degree.
- At least 10 years of experience in pharmaceutical manufacturing, with at least 5 years in Quality Assurance or Quality Control.
- Experience working with small molecules.
- Proven experience related to Health Authorities inspection, risk assessment and CAPA management.
- Thorough knowledge of manufacturing, both at development and commercial stages, and control of drug substances, drug products and combination products.
- Fluent in English. French, German or Italian are an advantage.
Apply:
Entitlement to work in the EEA is essential. Please quote job reference 99751 in all correspondence.