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QA Compliance Specialist

4 weeks ago

Sligo, Sligo, Ireland Collins McNicholas Full time

Our client based in Sligo is looking to hire a QA Compliance Specialist on an initial 12-month contract.

The Role:

As the QA Compliance Specialist, you will be responsible for documenting and establishing a quality system which ensures full compliance with all regulatory standards. You will report on the effectiveness of the quality system to senior management.

Responsibilities:

  1. Coordinating the quality system, ensuring full compliance by all personnel with its requirements.
  2. Coordination of Product Quality Reviews activities.
  3. Management of all Technical Agreements from initiation, review, approval, and storage.
  4. Coordination and Management of all Track and Trend activities to support Manufacturing and QC.
  5. Driving a QRM approach to all activities on-site.
  6. Coordination and facilitation of all Site RCS and FMEA activities.
  7. Auditing the quality system per the documented internal audit schedule. Assisting in the documentation, investigation of, and coordinating customer complaints/exceptions by ensuring implementation of effective corrective/preventive action where necessary.
  8. Ensuring that products manufactured at Company XXX meet requirements of end users, regulatory authorities, and the company.
  9. Measuring performance of the quality system and reporting on this at management review meetings and during quality performance meetings.
  10. Coordinating change management, change control, and change planning activities.
  11. Monitoring quality performance and advising management personnel on major quality issues.
  12. Liaison with AbbVie Global Quality Assurance, FDA, HPRA, and other regulatory bodies.
  13. Regulatory review.
  14. Initiation and completion of quality-related investigations and verification of the effectiveness of CAPAs as required.
  15. Establishing Corrective/Preventive Action system and procedures.
  16. Management of the Supplier program including the ASL, performance metrics, and audit schedules.
  17. Creation and approval of commodity specifications as required. Performance of vendor audits as required.
  18. Support all aspects of inspection readiness including preparation activities, logistic activities, generation of follow-up responses, and management of proof books.
  19. Adheres to and supports all EHS & E standards, procedures, and policies.

Requirements:

  1. Third-level degree in a science, quality, or engineering discipline.
  2. A minimum of three years' experience in a quality/operations role in a highly regulated manufacturing GMP environment (Pharmaceutical/Biologics/Medical Device).
  3. A strong knowledge of regulatory requirements is required.

For more information and a confidential discussion on the role, please contact Michelle Mc Inerney.

Skills:
Quality Systems Engineer

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