Aseptic Manufacturing Validation Professional

1 week ago

Cork, Cork, Ireland beBeeValidation Full time €60,000 - €90,000
Validation Specialist Role

An opportunity exists for a highly skilled Validation Specialist to join our organization in the implementation of comprehensive validation programs.

  • Review and validation of all IOQ documentation generated by vendors.
  • Preparation, execution, and summary reports from PQ stage onwards for a suite of equipment and instruments required for an aseptic fill finish facility incorporating Filling Line, Lyophilisers, Clean Utilities, Visual Inspection, QC Laboratories, and Warehousing.
  • Support and review of documentation from Calibrations and Thermal Mapping Vendors.

Responsibilities:

  • Evaluation of validation requirements including areas of new equipment, change controls, and new regulations.
  • Monitoring project status and obtaining updates where required, from a validation perspective.
  • Providing support to ensure that validation status reports are maintained through the issuing of regular reports and validation group meetings.
  • Liaising with project managers to ensure project schedules are adhered to.
  • Assessment of current practices to ensure compliance with cGMP requirements.
  • Review/implementation of procedures, reports, results, etc., for compliance.
  • Review/implementation of both global and site-specific documentation.
  • Coordination of SDLC Documentation.
  • Review and approval of project validation protocols plant-wide.
  • Review and approval of project change controls.
  • Input into the development of company validation standards.

Equal Opportunities Employer.

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