Senior Quality Assurance Specialist

14 hours ago

Nenagh, County Tipperary, Ireland beBeeQuality Full time €60,000 - €90,000
Job Opportunity: Quality Systems Professional

We are seeking a highly skilled quality systems professional to support our quality management activities in both the drug substance and drug product facilities.

Key Responsibilities:
  • Support quality assurance activities, including validation and regulatory audit support.
  • 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.

For success in this role, you should have a degree or postgraduate qualification in science, pharmacy, or engineering. 3+ years' experience in a regulated pharmaceutical manufacturing environment is preferred. Experience with quality system ownership, validation, and regulatory audit support is highly desirable. Additionally, experience in quality management systems such as Veeva, SAP, LIMS, Trackwise will be beneficial.

This role offers opportunities for career growth and development, a chance to work with a talented team, and contribute to the delivery of high-quality products.

It's an exciting time to join our organization, and we encourage you to apply if you have the necessary skills and qualifications.

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