Cleaning Validation Executor – Contract
Industry: Biopharma
Role Responsibilities:
* Taking Cleaning Validation samples alongside Upstream/Downstream processing.
* Working closely with manufacturing to ensure the CIP/SIP and dirty holds are to the correct times and samples are taken.
* Shows focus & a consistent approach to the role and tasks.
* Excellent people skills.
* Experience in aseptic technique.
* Experience in Gowning for ISO7/ISO8.
* Generating and Executing Validation Protocols.
* Actively look for Continuous improvements.
* Experience in Validation specifically cleaning validation.
* Experience in assessment of cleaning issues during study runs.
* Experienced Technical writer.
* Experience in Deviation/Change control writing.
* Capable of managing a large program, so project management skills would be necessary.
* An excellent understanding of how manufacturing/Cleaning Validation/Cleaning equipment works.
* Understanding of baseline studies for new equipment.
* Experienced in coverage testing and clean-into-service.
* Generate/review/Approval of CV protocols.
* Generate Reports.
* Maintain and update Cleaning Validation Plan.
* Schedule of cleaning activities with Manufacturing.
* Liaise with numerous departments.
* Ensure Training is maintained and current.
* Follow all EHS/Safety SOP/Policies.
Education and Experience:
* Experienced in QA Validation activities.
* Execution of cleaning validation protocols.
* Experience on writing and approving Deviations/GMP documents.
* Technical writing experience in writing site reports.
Duration: 1 year
Location: Limerick
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