Senior Quality Assurance Specialist

Morgan McKinley View all jobs

  • Cork
  • Permanent
  • Full-time
  • 1 month ago
Job Title: Senior Quality Specialist
Reporting To: Quality Lead
Employment Type: Full-TimeAbout the RoleOur client is seeking an experienced Senior Quality Specialist to join their growing Quality team within a regulated, ISO-certified environment. This is a key role focused on maintaining and continuously improving the Quality Management System (QMS), with a strong emphasis on supplier and customer quality management.The successful candidate will play a critical role in ensuring compliance with GMP and cGxP guidelines, supporting multinational customers in the bio/pharmaceutical market, and safeguarding product quality, patient safety, and supply chain integrity.This position requires a proactive, collaborative professional who thrives in cross-functional environments and takes ownership of quality systems and processes.Key Responsibilities
  • Lead investigation and documentation of non-conformances
Draft and execute Change Controls and CAPAs in a timely manner * Maintain and update QMS tracking tools and quality records
  • Perform Batch Record Review and material release (including CoA) in compliance with GMP requirements
  • Conduct QA review and approval of SOPs, Work Instructions, and associated documentation
  • Manage and support supplier approval processes
  • Coordinate customer and supply chain quality notifications
  • Support and execute internal and external audits, including regulatory and customer audits
  • Perform product release activities
  • Drive continuous improvement initiatives across the QMS
  • Contribute to monitoring and improving quality KPI metrics
Experience & Qualifications
  • 3-5+ years' experience in a Quality role within a GMP or regulated environment
  • Background in Bio/Pharmaceutical, Medical Device, Nutraceutical, or Food Science sectors
  • Degree in Science, Engineering, Technology, or related scientific discipline
  • Direct exposure to customer and regulatory audits
  • Prior experience as a system owner within a QMS
  • Strong understanding of GMP and cGxP requirements
  • Excellent documentation, communication, and cross-functional collaboration skills
What Our Client Is Looking For
  • A detail-oriented and highly organised quality professional
  • Strong analytical and problem-solving capabilities
  • Confident communicator with the ability to engage with customers and suppliers
  • A proactive mindset with a commitment to continuous improvement
This is an excellent opportunity for a motivated Quality professional looking to take the next step in their career within a dynamic and highly regulated industry.

Morgan McKinley