QA CLEANING VALIDATION EXECUTOR (CLEAN HOLDS) required by CareerWise Recruitment for our LIMERICK based client on an initial 12-month contract basis.
Role of this position
- Taking Cleaning Validation/ hold samples alongside Upstream/Downstream processing.
- Working closely with manufacturing to ensure the CIP/SIP and clean holds are to the correct times and samples are taken.
- Generating and executing Validation Protocols.
- Actively look for Continuous improvements.
- Technical writing/Deviation/Change Control writing.
- Capable of managing a large program, so project management skills would be necessary.
- Generate/review/approve of CV protocols and generate reports.
- Maintain and updating a Cleaning Validation Plan.
- Scheduling cleaning activities with Manufacturing.
- Liaising with numerous departments.
- Follow all EHS/Safety SOP/Policies.
- Experienced in QA Validation activities and execution of cleaning validation protocols.
- Experience in writing and approving Deviations/ GMP documents.
- Technical writing experience in writing site reports.
- An excellent understanding of how manufacturing/Cleaning Validation/Cleaning equipment works.
- Experience in Validation specifically cleaning validation and clean hold.
- Experienced in coverage testing desirable.
- Experience in gowning for IOS7/ISO8 advantageous.
- Experience in aseptic technique desirable.
- Experience in assessment of cleaning issues during study runs.
Please call Michelle Galvin today for further information on 091 373 938 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)