Biologics Manufacturing Expert

4 days ago


Limerick, Limerick, Ireland Regeneron Ireland DAC Full time

Job Overview:

Regeneron Ireland DAC is seeking a Biologics Manufacturing Expert to join our team. As a QA Specialist, you will play a key role in 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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