Compliance Specialist - Procurement
|Title||:||Compliance Specialist - Procurement|
|Sector||:||Supply Chain, Logistics & Materials|
Role of this positionSupport 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 qProcess deviations assigned to Sourcing (CAPAs, NOEs, EOEs) and support closure of QA Audits related to audits of raw material manufacturers and distributers. Essential Duties and Responsibilities include, but are not limited to, the following:
- 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.
- A 3rd Level Qualification in a related area. Relevant work experience may be substituted for educational experience.
- Experience with Supplier Relationship Management and 3-5 years of progressive experience in Procurement with an emphasis on Raw Materials experience.
- Strong attention to detail is required.
- 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 stakeholders
Please call Michael Hanrahan today for further information on 021-2019817 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.