*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
