Project Management (with Cleaning Validation experience)
Industry : Pharmaceutical
Department: QA Validation
Role Responsibilities of Project Management with Cleaning Validation experience includes:
- 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 IOS7/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.
Role Requirements:
- 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.
Location: Limerick
Contract Duration: 12-month contract