Senior Compliance Specialist (Quality Systems)

Competitive
Permanent
Limerick
15 May 2020
BBBH759461

Supplier Compliance and Quality Systems role which sits within the Procurement team

I am currently working with a leading biotechnology company that invents life-transforming medicines for people with serious diseases. This company are going through huge expansion at the moment and are on the look out for a Senior Compliance Specialist (Quality Systems role) to join their team on a Permanent Full Time basis.

This company will give you brilliant exposure to a fast paced, full on facility where the growth potential and promotional opportunities are well within your grasp. This is an excellent opportunity for anyone who loves to be kept busy and are highly career focused.

The key 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 organisation 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.

Responsibilities include:

  • Support and proactively maintain all Procurement cGMP procedures, documentation and training related to SOP and Work Instructions.
  • Support and maintain Approved Supplier List (ASL).
  • Work closely with Legal, QA and Suppliers to help facilitate the execution and management of various agreements, as required.
  • 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.
  • Support and assist with the management of Supplier Corrective Action Reports (SCARs)
  • 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.

Education and Experience:

  • A 3rd Level Qualification in a related area with 5+ years of relevant work experience.

If this sounds of interest, or if you would like to hear more then click the 'Apply Now' button below or reach out to Kellie on kodonovan@morganmckinley.com or 021 2300 300.

Other live vacancies:

  • Quality Compliance Specialist - Permanent - Bio - Limerick
  • Senior QA Specialist RM's - Permanent - Bio - Limerick
  • Validation Specialist - Permanent - Pharma - Cork
  • Quality Specialist - Permanent - Pharma - Cork
  • Quality Lead - Permanent - Essential Oils - Cork
  • Quality Systems Associate - Permanent - Biopharma - Cork

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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Kellie O'Donovan's picture
Consultant | Engineering Recruitment - Quality & Validation
Cork 353 (0) 21 2300300 | kodonovan@morganmckinley.com