Responsible Person

Employer
Manpower Ireland
Location
Dublin West, Dublin
Salary
Negotiable
Closing date
18 Sep 2020

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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
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