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Process Validation and Compliance Expert

2 weeks ago

Tullamore, Uíbh Fhailí, Ireland beBee Careers Full time
Key Responsibilities
  • Support new product introduction, process technology transfer, process validation, and the preparation of CMC documentation for regulatory filings.
  • Provide hands-on technical support for manufacturing process activities and support team input to investigations and resolution of process deviations, root cause analysis, CAPAs, process improvements, change controls, and preparation of regulatory filings.
  • Accountable for delivery of technical documents, including protocols, reports, and SOPs supporting the validation of the manufacturing process.
  • Strong knowledge of cGMP compliance, site and regulatory agency requirements, and provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies.