GDP Specialist – REF 01954MED

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 BMS 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

·         Ensure that a quality management system is implemented and maintained.

·         The Responsible Person/Deputy RP should be continuously contactable.

·         Focusing on the management of authorises and the accuracy and quality of 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 suppliers and customers are approved

·         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

·         Keeping appropriate records of any delegated duties

·         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).

·         Participate in GDP Management review activities

 

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