Quality Assurance Expert

23 hours ago

Nenagh, County Tipperary, Ireland beBeeQuality Full time €90,000 - €112,000

At the forefront of pharmaceutical innovation, we seek a dedicated Quality Systems Specialist to drive excellence in our drug substance and product facilities. This pivotal role requires expertise in supporting quality systems, driving performance metrics, and fostering continuous improvement.

Duties:

  • Develop and execute sub-system responsibilities as outlined in site ownership lists.
  • Promote quality performance through data-driven insights and process optimization.
  • Serve as a subject matter expert for validation across both Drug Substance and Drug Product operations.
  • Collaborate with cross-functional teams on PVC, WVC, CVG, and EQVC committees.
  • Review and approve validation documentation, ensuring adherence to regulatory standards.
  • Maintain validated states post-change, providing summary reports and quality plans.
  • Act as the primary quality contact for all site change requests affecting processing.
  • Conduct comprehensive reviews for change controls and material strategy assessments.
  • Provide QA oversight for laboratory systems, documentation, and incidents.
  • Approve stability reports and support OOS investigations.
  • Serve 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.
  • Authorize 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.
  • Promote GMP awareness and continuous improvement site-wide.

Educational and Experience Requirements:

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

This exciting opportunity offers a chance to join a leading organization and contribute to the development of high-quality products. If you are a motivated individual with a passion for quality assurance, please apply today

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