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.

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. 

You will be responsible for:

• Driving all QA related topics and be the main QA liaison for partners collaboration for development activities.
• Compliance to Quality assurance standards during the design, development, manufacture, supply and control of drug substances, drug products and combination products. Supervise the GMP/GDP Development QA group as assigned within the Quality Assurance group. Responsible for the Quality assessment during supplier/CMO evaluation.
• Leading issue resolution and QA review in area of expertise for CMC team as well as Supply chain stakeholders. Lead initiatives to improve quality in the relevant area, internally or through CMOs. Manage the investigations of complaints at CMO level and complete investigations review in given timelines.
• Leading the implementation of relevant quality agreements and manage communication with QA peers from the partners’ companies.
• Driving resolution of QA related problems linked to the partnerships. Notify management of potential quality and regulatory issues in close collaboration with CMOs.
• Ensuring a GMP/GDP compliant supply chain. Ensure the qualification status of the GxP environment where applicable.

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:

Please quote job reference 99751 in all correspondence.