Engineering & Electronics
QA Validation Technical Writer
- Contract
- Limerick, County Limerick, Ireland
- 42031181
The role:
PE Global is currently recruiting for numerous QA Cleaning Validation Engineers 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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