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Senior Validation Inspector

Egypt Otsuka
10th of Ramadan City, Cairo
Posted 5 years ago
50Applicants for1 open position
  • 47Viewed
  • 7In Consideration
  • 40Not Selected
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Job Details

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Job Description

  • Responsible for execution, monitoring, and reporting of the following
  1. All Classified areas Qualification
  2. Ampoule Machines SIP Validation
  3. Holding time Studies
  4. Autoclave Validation
  5. Steam quality test Qualification
  6. Compressed Air Quality test Qualification
  7. Thermal Mapping Studies for warehouses
  8. Vacuum Chambers Qualification
  9. Light intensity Qualification
  10. Mediafill aseptic simulation studies on Ampoule Machines
  11. Cleaning and Process Validation
  12. Equipment qualification
  13. All Pass Boxes Qualification
  14. All AHUs reconciliation and Qualification in coordination with engineering department (NEW )
  15. Monitoring all external activities done by the outsource and archive reports
  • Participate in SOPs creation and revising
  • Prepare the Validation calendar Plan and index Annually, validation protocols and reports
  • Prepare Validation Master Plan (Process and Cleaning)

Job Requirements

  • Bachelor’s degree in Pharmacy or scientific background
  • Minimum of 3 years of experience in the field.
  • Good command of English language
  • High communication skills and able to work in a team and able to interact with various priorities
  • Active, organized and planner with high attention for details
  • High physical and technical skills

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