External Quality Assurance Specialist

1 week ago


Dublin, Dublin City, Ireland Team Horizon Full time

Team Horizon is a leading biopharmaceutical company based in Dublin, seeking a talented individual to fill the role of External Quality Assurance Specialist.

About the Role

This exciting opportunity involves supporting ongoing quality assurance responsibilities in Contract Manufacturing oversight and quality systems. As a key member of our team, you will be responsible for ensuring compliance with industry standards and regulatory requirements.

Key Responsibilities
  • Maintain knowledge of industry standards and regulatory requirements to ensure compliance
  • Provide oversight of GMP systems completed by CMO's and External Supply Chain function related to Drug Substance, Drug Product and Finished Product
  • Support contract manufacturing organisation audits, including pre-approval inspections, as necessary
  • Develop and issue quality metrics pertaining to process quality activities
  • Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending

The ideal candidate will possess a minimum of 3-5 years' GMP related experience in biopharmaceutical/pharmaceutical or related industry, with experience working with contract manufacturing organisations.



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