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Quality Assurance Expert

2 weeks ago

Dublin, Dublin City, Ireland Cpl Healthcare Full time

Cpl Healthcare seeks a seasoned Quality Assurance Expert to support supplier quality operations in Dublin 15. This is a contract position that requires strong analytical and problem-solving skills.

The ideal candidate will possess a BSc in Science or a related discipline, with at least 2 years of experience in Supplier Quality or a related field in a Biologics or Pharmaceutical environment. In-depth knowledge of cGMP requirements for QA systems and compliance is essential. The role also demands excellent communication, presentation, time-management, and organizational skills.

Key Responsibilities:

  • Release incoming materials for use in manufacturing operations.
  • Support the qualification of new suppliers/materials and requalification of existing ones.
  • Assess supplier change notifications for impact on qualification status.
  • Support material certification and direct dispense programs.
  • Review and approve quality agreements.
  • Author, review, and approve QA-related procedures.
  • QA review, assessment, and approval activities for Biologics Manufacture, including change controls, deviations/investigations, CAPAs, and other associated documentation.
  • Support OpEx programs and champion continuous quality improvement initiatives.