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Senior Compliance Specialist - Sourcing

Reference:POR013003 Location: Limerick
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Purchasing Officer

A Senior Compliance Specialist – Sourcing is required to join a leading BioPharmaceutical organisation in Limerick. The focus of this role is to support and maintain all cGMP compliance aspects of Procurement operations under the direction and guidance of Procurement Management. Ensure organization and timely completion of Approved Supplier List documentation and provide Procurement support to effect closure of QA Audits related to audits of raw material manufacturers and distributors.

The Role

  • Support and proactively maintain all Procurement cGMP procedures, documentation and training related to SOP and Work Instructions.
  • Support and maintain Approved Supplier List (ASL).
  • Support compliance needs and coordinate with other sites to ensure engagement, feedback and buy in related to Procurement document revisions.
  • Supplier Audit Compliance – Drive successful audit closures by focusing on proactive issue resolutions and communication with suppliers to effect acceptable audit closures for raw materials.
  • Coordinate with Cross Functional Compliance resources to support Procurement and Quality Auditing needs for acceptable closure of audit findings and to secure evidence that substantiates supplier commitments. Track and report CAPA to support audit closure.
  • Execute cGMP compliance documents and support cGMP activities among the Procurement team.
  • Support and assist with the management of Supplier Corrective Action Reports (SCARs)
  • Work closely with Legal, QA and Suppliers to help facilitate the execution and management of various agreements, as required.
  • Complete Procurement change controls to ensure they are done correctly and effectively.
  • Work with Procurement staff to review and drive timely closure of NOE / deviations and associated processes (CAPA).
  • Action the Procurement responses to compliance related requests for data from Regulatory, Quality Assurance, Audit staff and other stakeholders.
  • Support the Procurement staff as required for assigned categories and participate in other procurement office duties as assigned.

  • The Person
  • A 3rd Level Qualification in a related area with 5+ years of relevant work experience.
  • cGMP experience is essential
  • Strong background in procurement/sourcing compliance and experience of leading CAPAs, deviations and/or SCARs