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Senior Validation & Calibration Specialist

Egypt Otsuka
10th of Ramadan City, Cairo
Posted 5 years ago
50Applicants for2 open positions
  • 41Viewed
  • 24In Consideration
  • 17Not Selected
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Job Details

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Job Description

Responsible for execution, monitoring, and reporting of the following:

  • All Classified areas Qualification
  • Ampoule Machines SIP Validation
  • Autoclave Validation
  • Steam quality test Qualification
  • Compressed Air Quality test Qualification
  • Thermal Mapping Studies for warehouses
  • Vacuum Chambers Qualification
  • Light intensity Qualification
  • Media fill aseptic simulation studies on Ampoule Machines
  • Cleaning and Process Validation
  • equipment qualification
  • All Pass Boxes Qualification
  • All AHUs reconciliation and Qualification in coordination with the engineering department
  • Monitoring all external activities done by the outsourcing and archive reports
  • Participate in SOPs creation and revising
  • Prepare the Validation calendar Plan and index Annually, validation protocols and reports

Responsible for Calibration, Monitoring, and reporting of the following:

  • Temperature Sensors
  • Calibration for all devices and cougar, sensors in all factory and QC lab
  • Thermal mapping for the controlled room – QC lab
  • Conductivity Meters
  • All Tablet section IPC lab devices(Disintegration, friability, Hardness, and thickness)
  • Thermo hygrometer calibration
  • Participate in SOPs creation and revising
  • Prepare the Calibration calendar Plan and index Annually

Job Requirements

  • Bachelor’s degree in Pharmacy, scientific or Engineering
  • Minimum 3 years of experience in the field.
  • Good command of English language and computer skills
  • High leadership skills.
  • Team building and motivations skills.
  • 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 observation skills

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