Batch Release Professional
5 days ago
Company Overview:
Regeneron Ireland DAC is a world-leading biopharmaceutical company dedicated to discovering and developing innovative medicines that improve the lives of patients worldwide.
Job Summary:
We are seeking a talented Batch Release Professional to join our team, responsible for ensuring the quality and compliance of our products throughout the manufacturing process.
Key Responsibilities:
- Product Disposition: Perform activities in support of product disposition, ensuring compliance with Quality Assurance (QA) policies and procedures.
- Bulk Data Review: Review bulk data related to product release and prepare batch records.
- Status Labeling: Perform status labeling of product as needed.
- Deviation Management: Complete deviation reports, change control, and batch record reports to support product disposition.
- Representative Role: Represent Quality Assurance in support of deviations, CAPAs, and interactions with external partners.
- Process Evaluation: Evaluate Regeneron processes and procedures for continuous improvement.
Requirements:
- Education: Degree or Masters in a scientific field.
- Experience: Associate Level requires 0-2 years experience, for Specialist level 3 years experience is required and Sr Specialist you must have 5+ years experience directly related experience.
- Skillset: Excellent organisational skills, attention to detail, good written, verbal and interpersonal communication skills, ability to prioritise multiple assignments and changing priorities, ability to learn and utilise computerised systems for daily performance of tasks, ability to prioritise, manage multiple tasks, and meet deadlines.
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