Description
We have a new project available for an experienced Senior Quality Manager to take charge of collaboration framework with external suppliers related to raw materials and drug substance supply.Responsibilities:
- Management of Suppliers framework (internal and external inspections, budget approval, performance KPI measurement, supplier qualifications).
- Manage quality aspects at external suppliers and ensure their compliance with good manufacturing practice.
- Manage and evaluate change notifications from external suppliers.
- Write GMP relevant documents in area of responsibility (SOPs, Quality Agreement, APS) and ensure implementation at third parties.
- Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority guidances, SOPs, HSE, etc.
Requirements:
- Degree in scientific or relevant discipline (BS or equivalent).
- Prior experience gained in the pharmaceutical company
- Experience in external supplier management
- Good knowledge of cGMPs, working knowledge of safety and environmental regulations and guidelines.
- Good knowledge of drug development and drug substance production.
- Proven track in analysing and evaluating GMP compliance.
- Fluent written and spoken English.
This is 12 months contract and based on site.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.