Job Description

  • RQ of Utilities (WFI)
  • Process RQs (SIP, Bulk Sterilization, Autoclave)
  • Cleaning validation
  • Warehouse mapping
  • Filtration skids
  • Mixing tank
  • Washer qualification
  • Trending of Results
  • Data mining
  • LIMS queries
  • Develop, review and/or approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion.
  • Lead project validation activities, and provide basic guidance and direction to junior project engineer as required.
  • Review Turnover / Vendor Packages as part of the project deliverables to support qualification activities.
  • Manage qualification execution and lead validation deviation investigation encountered in qualification
  • Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification activities.

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