Operational Excellence Lead

2 weeks ago

Nenagh, County Tipperary, Ireland beBeePharmaceutical Full time €75,000 - €100,000
Job Title:

Quality Systems Specialist


Job Description:

We are seeking a Quality Systems Specialist to join our team. In this role, you will be responsible for supporting the quality systems activities in both Drug Substance and Drug Product facilities.


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.

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