Associate Compliance Specialist - Sourcing

An Associate Compliance Specialist – Sourcing is required to join a leading global Biopharmaceutical business in Limerick. The key focus of this role is to support and maintain all cGMP compliance aspects of Strategic Sourcing & Procurement (SS&P) operations under the direction and guidance of Sourcing Management. Ensure organization and timely completion of Approved Supplier List documentation in addition to process deviations assigned to Sourcing (CAPAs, NOEs, EOEs) and support closure of QA Audits related to audits of raw material manufacturers and distributers.

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 consensus 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.
• 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 the need arises.
• Complete Procurement change controls to ensure they are done accurately and optimally.
• 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 partners.

• A 3rd Level Qualification in a related area.
• Experience with Supplier Relationship Management and dynamic experience in Procurement with an emphasis on Raw Materials experience.
• Understanding of cGMP systems and processes with a particular emphasis on compliance is strongly preferred.
• Microsoft Office required including strong Power Point and Excel skills.
• Familiarity and experience working in an ERP system is preferred.
• Excellent collaboration skills and the ability to work cross functionally across categories and internal partners