Responsibilities:
- Ensure that the quality management system is compliant with GDP requirements
- Maintain the GDP training program
- Ensure that relevant transportation and distribution complaints are dealt with effectively
- Ensure that the system for approving suppliers and customers is effective
- Approve any subcontracted activities which may impact on GDP
- Provide quality distribution support to the Quality Operations Managers
- Provide GDP support to the wider Supplier Relationship Management, Global Procurement, Supply Chain and MT teams in support of new projects, technical transfers programs, supplier selection programs, investigations, etc.
- Support the Global external auditing program by participation in audits of Third Parties as requested
- Provide support to specified quality and technical projects as they arise
- Support gap analysis of site SOPs / quality directives / policies / global HA observations as the SME for Quality Distribution for EMEA and ensure gaps are mitigated.
- Support assessments of product impact due to temperature excursions during transportation
- Participate in self-inspections and track necessary corrective measures are put in place
- Coordinate GDP quality metrics programs
- Keep appropriate records of any duties delegated from the Responsible Person
- Ensure that any additional requirements imposed on certain products by National Law are adhered to (Article 83 of Directive 2001/83/EC)
- Participate in GDP Management review activities
- Support the review and update of all procedures covering the scope of the wholesale distributor's activities
- Provide general GxP HA inspection support (preparation, back-room support, etc.)
- Assist with quality agreements
- The Responsible Person/Deputy RP should be continuously contactable.
- Focusing on the management of authories and the accuracy and quality of records.
- Coordinate and promptly perform any recall operations for medicinal products
- Approve any subcontracted activities which may impact on GDP
- Ensure 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
- Ensuring that any additional requirements imposed on certain products by National Law are adhered to (Article 83 of Directive 2001/83/EC).
- Approve, sign and date all procedures covering the scope of the wholesale distributor's activities