Main purpose of role:
- The Supplier Assurance Team is responsible for the Quality related aspects of Supplier Management, ensuring Quality Technical Agreements and API QP declarations are in place and maintained.
- This role provides a good opportunity to gain exposure and knowledge of a range of functions and activities in the Pharmaceutical industry. The role requires cross-functional/departmental interaction working closely with Supply Chain, Supplier Alliance, Regulatory, Operational Projects, New Product Introduction and Quality.
- This role also includes responsibility for official authorisation maintenance.
- Coordinate GMP / GDP Quality Technical agreements for approximately 300 third party manufacturers, distributors and laboratories. Ensure all elements of GMP / GDP responsibility are correctly assigned through consultation with Supply Chain, Legal and Quality teams and ensure that scheduled review periods are assigned and met.
- Liaise with the third-party manufacturers, distributors and laboratories to gain agreement and approval for the Quality Technical agreements and assist in resolving any queries.
Coordinate requests for Active Pharmaceutical Ingredient (API) declarations from the Qualified Person at third party manufacturers. Provide timely feedback to Regulatory and Business Development teams on the progress of API declarations.
- Maintain SOP and WIs for Technical Agreements and QP Declarations.
Ensuring that the company processing licences (e.gs MIA / MS / WDA / ASR) are kept up to date and reflect all changes made to the organisation and product portfolio.
- Assist with corrective and preventative action plans (both internally and with external suppliers).
- Ensure risks associated with supplier issues are risk assessed and are appropriately classified and communicated/escalated where the continued use of the suppliers is justified.
Other activities as may be required, at the discretion of management