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.)
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