Regeneron Quality Expert
2 days ago
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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