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Senior Aseptic Operations Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeAseptic Full time €60,000 - €85,000
Quality Assurance Specialist

We are seeking a skilled Quality Assurance Specialist to join our team in Dublin. This is an excellent opportunity to work with a leading biotechnology company and be part of their growth journey.

Job Responsibilities:
  • Testing primary and secondary components for aseptic products
  • Sampling of Excipients and Drug Substance under Grade C conditions
  • Reviewing and approving documentation related to component testing
  • Compiling, reviewing, and approving minor NC and CAPAs for closure
  • Providing training and advice to staff on testing procedures
  • Participating in audits and preparation activities
  • Reviewing cGMP records to ensure compliance
  • Writing, reviewing, and approving SOPs
  • Performing activities in compliance with safety standards and SOPs
  • Supporting continuous improvement initiatives
Requirements:
  • University degree in Engineering or Science preferred
  • 4+ years of relevant experience in pharma or biotech industry
  • Excellent communication skills
  • Experience with cross-functional teams, decision making, problem solving, Root Cause Analysis, Non-Conformance, and Deviations
  • Experience in aseptic operations, protein formulation, vial and syringe filling
What We Offer:

This role offers the opportunity to work in a state-of-the-art facility and be part of a forward-thinking company. The successful candidate will have the chance to develop their skills and contribute to the company's success.