Regulatory Compliance Specialist
6 days ago
About the Role:
We are looking for a highly motivated and experienced Regulatory Compliance Specialist to join our team at Regeneron Ireland DAC. As a QA Specialist, you will be responsible for ensuring the quality and compliance of our biologics manufacturing operations.
Key Responsibilities:
- Preparation and review of batch disposition documentation to support QP release of Formulated Drug Substance
- Review of QC related release data and documentation
- Completion of deviation, change control & batch record reports to support disposition
- Status labelling of product as needed
- Representation of Quality Assurance in support of deviations, CAPAs, etc
- Liaison with external partners and provision of input on regulatory communications
- Training and mentoring of employees on processes and procedures
- Consultation or advice in alignment with QA policies
- Review, editing, or approval of controlled documents
- Interaction with various departments to ensure batch release deliverables are met
- Evaluation of 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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