Quality Assurance Specialist

4 hours ago

Dublin, Dublin City, Ireland beBeeQuality Full time €55,000 - €85,000

Job Title: Quality Assurance Specialist

We are seeking a highly skilled Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in quality assurance, with experience in GMP manufacturing and regulatory compliance.

Key Responsibilities:
  • Review and approve production documentation, including Master Batch Records and Electronic Batch Records, to ensure accuracy and compliance with cGMPs and company procedures.
  • Provide quality coaching and guidance to support compliance and data integrity on the shop floor.
  • Actively participate in the Tier process to identify and resolve quality issues.
  • Support the completion of batch disposition activities for product release and conduct investigations into deviations.
Requirements:
  • Bachelor's degree in a scientific or engineering field, preferably with 5+ years of relevant post-degree work experience in GMP Manufacturing, Quality Assurance, or Laboratory environment.
  • Strong knowledge of cGMPs and regulatory requirements, with ability to communicate effectively and work collaboratively in a team environment.
  • Demonstrated leadership skills and proficiency in authoring and approving GMP documents.
Work Environment:
  • This role is part of a Quality IPT (Integrated Product Team) and reports to the Associate Director of Quality Operations.
  • The successful candidate will be expected to spend significant time on the shop floor, working closely with cross-functional teams to drive continuous improvement and enhance operational efficiency.

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