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Validation Specialist

Posted 08/11/2021
£30,000 per annum
Stirling
Full time


Our client in Stirling is looking for a validation specialist to support the delivery and control of all site validation activities, to ensure compliance levels associated with a cGMP facility are achieved. This will be done by:

  • Support the Site validation activities within a cGMP facility by maintaining the equipment/process qualification status to an agreed schedule
  • Ensuring you work to and comply with all validation policies and procedures
  • Assist with the preparation and issuing of relevant controlling SOP’s / Protocols / Reports
  • Present the Validation status at the Quality Review Board when required
  • Define and execute all tasks in line with Health and Safety standards
  • Present relevant reports and procedures at Regulatory and Client audits
  • Assist, where required, with Quality Management activities / investigations
  • Keep abreast of industry standards and trends in validation, providing in house guidance and training as required.
  • Support the execution of Qualification activities around the Sales & Manufacturing schedule ensuring ongoing equipment availability and minimised disruption of the operation.
  • Act as a back-up for the Manufacturing team, ensuring qualification for clean room access and support activities

The ideal candidate will be educated to a degree level in a scientific discipline with knowledge of pharmaceutical manufacture and validation principles within a GMP environment, including hands-on protocol writing, execution, sample coordination and report writing skills. You should have specialist validation knowledge and experience in equipment validation (Autoclaves/Ovens/HVAC/Freeze Driers/Equipment Washers) and / or process / computer validation and have experience using freeze drier operations.



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