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.