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Senior Quality Assurance Manager
Eingestellt von Michael Bailey Associates - UK Contracts
Projektbeschreibung
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.
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.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges