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Regulatory Affairs Specialist

2 weeks ago

Cork, Cork, Ireland PSC Biotech Corporation Full time
About PSC Biotech Corporation

PSC Biotech Corporation is a Biotech Consultancy firm with a presence in Ireland, India, Singapore, Australia, and the US.

We provide software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

Job Expectations

The Senior Quality Assurance Specialist supports GMP Quality Assurance activities at the facility and is responsible for ensuring compliance with relevant regulations and standards.

Key Responsibilities
  • Review and approve production and analytical documentation to ensure compliance with SOPs, GMP, and regulatory requirements.
  • Perform and review complaints and deviation investigations, change controls, and CAPAs.
  • Create and maintain assigned SOPs.
  • Compile data for reports and presentations, provide data interpretation, and draw conclusions.
  • Complete audits to ensure compliance with SOPs, GMPs, and applicable regulations.
  • Support product recalls and stock recoveries as appropriate.