This role focuses on QA Validation activities, with a particular emphasis on SIP processes and thermal mapping. The ideal candidate will bring expertise in validation protocols, technical writing, and cross-departmental collaboration to ensure compliance and quality excellence across manufacturing operations.
This is a 12-month contract offering competitive LTD/Umbrella rates, providing an excellent opportunity to work alongside experts in a world-class facility.
Job Responsibilities:
* QA Validation activities
* Review & approval of SIP thermal mapping and Performance Qualification validation protocols
* Writing and approving Deviations
* Technical writing for generation of protocols and reports
* TC and BI placement
* Troubleshooting to investigate issues if and when they occur
* Generate/review/approval of SIP protocols
* Generate reports
* Schedule of SIP activities with Manufacturing
* Liase with numerous departments
Requirements:
* Experience in Validation specifically Steam in Place
* Experience in KAYE validator usage
* Experience in review and approval of KAYE validator report and study runs
* Experience in SIP thermal mapping, TC and BI placement
* Experienced Technical writer
* Experience in Deviation writing
* Troubleshooting to investigate issues if and when they occur
* An excellent understanding of how manufacturing and steam sanitization and sterilization works
* Generate/review/approval of SIP protocols
* Generate reports
* Schedule of SIP activities with Manufacturing
* Liase with numerous departments
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