Quality Assurance Manager

3 days ago

Nenagh, County Tipperary, Ireland beBeeQuality Full time €45,000 - €55,000

Quality Systems Specialist Role

  • This is an opportunity to support quality systems activities in both drug substance and drug product facilities.
  • The Quality Systems Specialist will drive quality performance metrics and continuous improvement within owned systems.

Duties:

  • Complete responsibilities per site System Ownership List.
  • Drive quality performance metrics and continuous improvement within owned systems.
  • Serve as quality SME for validation across drug substance and drug product operations.
  • Participate in PVC, WVC, CVG, and EQVC committees.
  • Approve validation documentation and support capital projects.
  • Maintain validated state post-change; develop summary reports and quality plans.
  • Principal quality contact for all site change requests affecting processing.
  • Conduct full lifecycle reviews for change controls and material strategy assessments.
  • Provide QA oversight for laboratory systems, documentation, and incidents.
  • Approve stability reports and support OOS investigations.
  • Act as the microbiology QA point of contact for water, utilities, environment, and product-related issues.
  • Own and maintain the Site Master File, Validation Master Plan, and key procedures.
  • Oversee annual review and quality agreement systems.
  • Approve user access reviews and site application controls.
  • Participate in internal audits, customer complaints, and supplier change evaluations.
  • Support site regulatory inspections and license/filing documentation requests.
  • Manage returned goods disposition in line with quality requirements.
  • Lead scheduling, minutes, and follow-ups for monthly quality council meetings.
  • Actively promote GMP awareness and continuous improvement site-wide.

Requirements:

  • A degree or post-graduate qualification in science, pharmacy, or engineering is required.
  • 3+ years' experience in a regulated pharmaceutical manufacturing environment preferred.
  • Experience with quality system ownership, validation, and regulatory audit support is highly desirable.
  • Experience in quality management systems such as Veeva, SAP, LIMs, Trackwise.

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