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Job Description

Quality Systems Specialist Role

This is an excellent opportunity for a Quality Systems Specialist to join a leading multinational organization in Tipperary. The role requires the specialist to support the quality systems activities in both the drug substance and drug product facilities.

The successful candidate will be responsible for completing sub-system responsibilities per site system ownership list, driving quality performance metrics and continuous improvement within owned systems, and serving as a quality SME for validation across drug substance and drug product operations.

Key Responsibilities:

  • Complete sub-system 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