Regeneron Quality Expert

2 days ago


Limerick, Limerick, Ireland Regeneron Ireland DAC Full time
About Us:

We are Regeneron Ireland DAC, a leading biopharmaceutical company committed to developing innovative treatments for serious diseases. Our mission is to discover and develop medicines that make a meaningful difference in people's lives.

Job Overview:

This is an exciting opportunity to join our team as a Quality Assurance Specialist. As a member of our quality team, you will play a critical role in ensuring the highest standards of quality and compliance across our operations. If you have a strong background in quality assurance, excellent communication skills, and a passion for delivering exceptional results, we encourage you to apply.

Responsibilities:
  • Ensure compliance with quality assurance policies and procedures, GMPs, SOPs, and Regeneron Standard Requirement Documents
  • Prepare and review batch disposition documentation to support QP release of Formulated Drug Substance
  • Review QC related release data, document review
  • Complete deviation, change control & batch record reports to support disposition
  • Perform status labelling of product as needed
  • Represent Quality Assurance in support of deviations, CAPAs, etc.

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