The role:
PE Global is currently recruiting for numerous Technical Writers on behalf of a leading biotech company based in Limerick. This is an initial 12 month contract role.
Responsibilities:
* Execution of cleaning validation protocols.
* 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.
* 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
* Actively look for Continuous improvements
Experience:
* Experienced in QA Validation activities –
* Extensive experience on writing and approving Deviations/GMP documents
* Technical writing experience in writing site reports
* Experience in aseptic technique
* Experience in Gowning for IOS7/ISO8
* Generating and Executing Validation Protocols.
* Experience in Validation specifically cleaning validation
* Experience in assessment of cleaning issues during study runs,
* Experienced Technical writer,
* Experience in Deviation/Change control writing,
* Experienced in coverage testing and clean-into-service
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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