Senior Quality Systems Expert

2 days ago

Dublin, Dublin City, Ireland beBeeQuality Full time €69,891 - €93,293
Quality Assurance Role

We are dedicated to creating healthier communities worldwide through education, outreach and better access to treatment.

Our global portfolio includes best-in-class products as well as generics across a wide range of therapeutic areas.

  • Key Responsibilities:
    • Collaborate with manufacturing and engineering teams to drive quality awareness, facilitate Good Manufacturing Practices and implement improvements to ensure product quality.
    • Implement and monitor key quality indicators within the manufacturing processes to identify unexpected events and preventative measures in order to ensure continued product quality.
    • Conduct checks and reviews of manufacturing operations to monitor factors which may affect product quality.
    • Review and evaluate all internal executed batch records to facilitate disposition of product for Batch release
    • Review externally manufactured product documentation
    • Participate in site commissioning and qualification program
    • Review and participate in all deviations and changes to manufacturing operations to ensure appropriate investigation and assessment carried out and actions implemented and monitored.
    • Support complex site and 3rd party investigations, present issues to the Quality Professional in clear and concise manner
    • Manage On Hold & Reject lists for the site
    • Key Deliverables:
      • Continued product quality through the Quality System by Supporting product launches and commercial activities by coordinating with third parties, managing change controls, and preparing key regulatory documents.
      • Maintaining oversight of manufacturing operations, contributing to Product Quality Records (PQRs), participating in self-inspections, and ensuring alignment with regulatory guidelines through active use of Quality Risk Management and training support.

Benefits

  • Opportunity to work on complex projects and collaborate with cross-functional teams.
  • Continuous learning and development opportunities.
  • Recognition and rewards for outstanding performance.

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