Manager Distribution Quality/ Deputy Responsible Person

Manager Distribution Quality/ Deputy Responsible Person - Dublin - Contract

A global pharmaceutical organization specializing in the treatment of cancer, serious mental illness, HIV/AIDS, hepatitis B, rheumatoid arthritis, cardiovascular disease, organ transplant and diabetes are currently looking for an experienced "Manager Distribution Quality/ Deputy Responsible Person". This is a long term contract opportunity based on Ireland’s east coast.

• Ensure that the quality management system is implemented and maintained, compliant with GDP requirements
• Focus on the Management of authorisations and the accuracy and quality of GDP records
• Ensure that initial and continuous training programmes are implemented and maintained. Ensure that all relevant personnel maintain their competence in GDP through regular training
• Coordinate and promptly perform any recall operations for medicinal products
• Ensure that relevant customer complaints are dealt with effectively
• Ensure that relevant transportation and distribution complaints are dealt with effectivelyApprove any subcontracted activities which may impact on GDP
• Ensure that the system for approving suppliers and customers is effective
• Ensure that suppliers and customers are approvedProvide 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.
• 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
• Approving any returns to saleable stock
• Ensuring that any additional requirements imposed on certain products by National Law are adhered to (Article 83 of Directive 2001/83/EC).
• 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