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Senior Quality Assurance Lead

3 weeks ago

Dublin, Dublin City, Ireland beBeeAssurance Full time €90,000 - €110,000
Job Role:

Quality Assurance Professional

Key Responsibilities:
  • Collaborate with the Quality Team to maintain and enhance the Company's Quality Management System (QMS)
  • Ensure compliance with ISO 9001 and GMP requirements, as well as internal procedures
  • Manage the QMS by identifying, documenting, and implementing non-conformances, change controls, corrective actions, quality complaints, and supplier evaluations
  • Maintain accurate records of supplier assessments and repeat evaluations in accordance with internal procedures
  • Conduct internal audits and ensure ongoing improvement of the QMS
  • Communicate effectively with team members and stakeholders regarding changes to the QMS
Responsibilities for Responsible Person:
  • Guarantee compliance with EU GDP guidelines, HPRA local guidelines, and other relevant regulations
  • Experience working under MHRA GDP requirements is an asset
  • Ensure the safety, quality, and traceability of products throughout the supply chain
  • Verify that all medicinal products are stored, transported, and delivered under strict GDP conditions
  • Ensure timely completion of supplier /customer/service provider bona fides and conduct regular reviews
  • Perform self-inspections and audits as per the written audit schedule
  • Act as the primary point of contact and be legally responsible for HPRA notifications and updates for nominated WDAs
  • Lead regular management review meetings with senior management teams
  • Cultivate and mentor quality professionals and deputy RPs
  • Ensure patient and product safety at all times