The main responsibility of the Responsible Person of Upjohn Legal Entity will be to work with the PSC (Pfizer Service Company) team and key stakeholders including Customer Service Operations, IICC (Inbound, Inventory, Compliance, Controlled Substances), Customs and ICMD (Intercompany Master Data) to ensure that all products physically and/or financially owned by Upjohn are released for sale to global markets in accordance with the EU GDPs.
The role has accountability for the implementation, execution, monitoring and compliance of the Quality Systems in support of the release for sale activities. This person act as an RP of behalf of Upjohn.
- Review, evaluate and support complex investigations and present formal notifications of significant issues to senior management and Quality Review Teams
- Ensure fulfillment of local legal regulations; ensure that the provisions of the licence are observed
- Ensure that the operations do not compromise the quality of medicines
- Ensure monthly metrics are gathered and communicated in a timely way
- Act as RP for Upjohn for the GDP licenses responsible for as notified to the respective BoH.The RP is responsible for safeguarding product users against potential hazards arising from poor distribution practices.
- Ensuring that a quality management system is implemented and maintained
- Focusing on the management of authorised activities and the accuracy and quality of records
- Ensuring that initial and continuous training programmes are implemented and maintained
- Coordinating and promptly performing any recall operations for medicinal products
- Ensuring that relevant customer complaints are dealt with effectively if applicable
- Ensuring that suppliers and customers are approved
- Approving any subcontracted activities which may impact on GDP
- Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place
- Deciding on the final disposition of returned, rejected, recalled or falsified products
- Approving any returns to saleable stock