Biologics Manufacturing Operations Specialist

3 days ago


Limerick, Limerick, Ireland Regeneron Ireland DAC Full time
About the Role:

We are seeking a highly skilled Quality Assurance Specialist to join our team at Regeneron Ireland DAC. The successful candidate will play a critical role in ensuring the highest standards of quality and compliance across our operations. This is an excellent opportunity for someone who has a strong background in quality assurance, excellent communication skills, and a passion for delivering exceptional results.

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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