• 12 Month Contract
  • Limerick

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
  • 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

To apply for this job email your details to enquiries@qaresources.com.