Project Management (With Cleaning Validation Experience)

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

#J-18808-Ljbffr