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QA Compliance Specialist

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 22232

Our client based in Sligo are 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 be responsible for reporting on the effectiveness of the quality system to senior management.

Responsibilities:

  • Coordinating the quality system, ensuring full compliance by all personnel with its requirements.

  • Coordination of Product Quality Reviews activities.

  • Management of all Technical Agreements from initiation, review, approval and storage.

  • Coordination and Management of all Track and Trend activities to support Manufacturing and QC.

  • Driving a QRM approach to all activities on site.

  • Coordination and facilitation of all Site RCS and FMEA activities.

  • 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.

  • Ensuring that products manufactured at Company XXX meet requirements of end users, of regulatory authorities and of the company.

  • Measuring performance of the quality system and reporting on this at the management review meeting and during quality performance meetings.

  • Coordinating change management, change control and Change planning activities.

  • Monitoring quality performance and advising management personnel on major quality issues.

  • Liaison with Global Quality Assurance, FDA, HPRA and other regulatory bodies.

  • Regulatory review.

  • Initiation and Completion of Quality related investigations and verification of the effectiveness of CAPA’s as required.

  • Establishing Corrective / Preventive Action systems and procedures.

  • Management of the Supplier program including the ASL, Performance metrics and Audit Schedules

  • Creation and approval of commodity specifications as required Performance of Vendor audits as required

  • Support all aspects of inspection readiness including preparation activities, logistic activities, and generation of follow up responses and management of proof books.

  • Adheres to and supports all EHS & E standards, procedures and policies

Requirements

  • Third-level degree in a science, quality or engineering discipline.

  • A minimum of three years experience in a quality/operations role in a highly regulated manufacturing GMP environment (Pharmaceutical/Biologics/Medical Device)

  • A strong knowledge of regulatory requirements is required.

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

michelle.mcinerney@collinsmcnicholas.ie

091 706717