GMP Quality Control Manager
3 days ago
About the Company:
Regeneron Ireland DAC is a leading biopharmaceutical company that develops and commercialises innovative medicines for serious diseases. We are committed to improving human health and well-being through science-based innovation.
Job Summary:
We are seeking a GMP Quality Control Manager to join our team. As a QA Specialist, you will be responsible for ensuring the quality and compliance of our biologics manufacturing operations.
Key Responsibilities:
- Review and approve batch disposition documentation to support QP release of Formulated Drug Substance
- Review QC related release data and documentation
- 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
- Liaise with external partners and provide input on regulatory communications
- Train & mentor employees on processes and procedures
- Provide consultation or advice in alignment with QA policies
- Review, edit, or approve controlled documents
- Interact with various departments to ensure batch release deliverables are met
- Evaluate Regeneron processes and procedures for continuous improvement
Requirements:
- Degree or Masters in a scientific field
- 3 years experience required for Specialist level, 5+ years experience required for Sr Specialist
- Excellent organisational skills and attention to detail
- Good written, verbal and interpersonal communication skills
- Able to prioritise multiple assignments and changing priorities
- Able to learn and utilise computerised systems for daily performance of tasks
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