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QA Compliance Specialist 3 Days Left

1 month ago

Sligo, Sligo, Ireland Collins McNicholas Recruitment Full time
Job Description

We are seeking a QA Compliance Specialist to join our team in Sligo on an initial 12-month contract.

The Role:

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

Responsibilities:
  • Coordinate the quality system to ensure full compliance by all personnel with its requirements.
  • Coordinate Product Quality Reviews activities.
  • Manage all Technical Agreements from initiation, review, approval, and storage.
  • Coordinate and manage all Track and Trend activities to support Manufacturing and QC.
  • Drive a QRM approach to all activities on site.
  • Coordinate and facilitate all Site RCS and FMEA activities.
  • Audit the quality system per the documented internal audit schedule.
  • Assist in the documentation, investigation of, and coordination of customer complaints/exceptions by ensuring implementation of effective corrective/preventive action where necessary.
  • Evaluate that products manufactured at Company XXX meet the requirements of end users, regulatory authorities, and the company.
  • Measure performance of the quality system and report on this at the management review meeting and during quality performance meetings.
  • Coordinate change management, change control, and change planning activities.
  • Monitor quality performance and advise management personnel on major quality issues.
  • Liaise with AbbVie Global Quality Assurance, FDA, HPRA, and other regulatory bodies.
  • Perform regulatory reviews.
  • Initiate and complete quality-related investigations and verify the effectiveness of CAPA's as required.
  • Establish a Corrective/Preventive Action system and procedures.
  • Manage the Supplier program, including the ASL, Performance metrics, and Audit Schedules.
  • Create and approve commodity specifications as required; perform Vendor audits as required.
  • Support all aspects of inspection readiness, including preparation activities, logistic activities, generation of follow-up responses, and management of proof books.
  • Adhere to and support all EHS & E standards, procedures, and policies.
Requirements:
  • Hold a third-level degree in a science, quality, or engineering discipline.
  • Have a minimum of three years' experience in a quality/operations role in a highly regulated manufacturing GMP environment (Pharmaceutical/Biologics/Medical Device).
  • Possess a strong knowledge of regulatory requirements.