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Quality Compliance Specialist

Reference:PORA006722 Location: Limerick
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: EHS Specialist, Quality Specialist

A Quality Compliance Specialist QRM is required to join a leading global biopharmaceutical organisation in Limerick. This role supports the work of our client’s Industrial Operations and Product Supply (IOPS) site through the use of quality risk management (QRM) principles and techniques. The scope may also include collaboration with other IOPS Sites, partners, CMOs and their respective programs.

The Role

  • Ensuring compliance with all aspects of the QRM program
  • Provide advice on all QRM matters within the IOPS organization
  • Facilitate risk assessments
  • Responsible for review and approval of QRM documentation
  • Administration and oversight activities for the site QRM quality system
  • Review procedures, policies and other instructional documents relating to QRM to ensure compliance with company policy and local and international regulatory requirements
  • Provision of monitoring and trending metrics associated with QRM
  • Actively participate in continuous improvement initiatives
  • Participates in regulatory and customer audits representing Regeneron’s approach to QRM
  • Collaborates with functional departments to resolve issues and maintain compliance
  • Identify gaps in systems and works with management to develop feasible plans for correction
  • Coordinate with IOPs QRM team to ensure consistency of execution and documentation across IOPs sites

The Person

  • Requires a third level qualification (Ireland) or B.S. (US) in a scientific discipline or related field with 3+ years of relevant work experience within the pharmaceutical or biopharmaceutical or related industry.
  • Experience in the pharmaceutical/medical device/biotechnology industry with proven experience in leading cross functional teams preferred.
  • Good working knowledge of electronic Quality Management Systems and associated metric generation preferred
  • Proficient at report generation using Excel and other MS Office applications.

If you would like further Information you can contact the recruiter directly:

Paula O'Reilly | Tel: +353 (0) 1 507 9265