Yahia Elmasry

CTD section head at Utopia Pharmaceuticals
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Contact Information
us****@****om
(386) 825-5501
Location
Egypt, EG
Languages
  • English -
  • Arabic Native or bilingual proficiency

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Experience

    • Egypt
    • Pharmaceutical Manufacturing
    • 300 - 400 Employee
    • CTD section head
      • Oct 2021 - Present

    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Senior Registration, Follow up& Document Control
      • Jan 2016 - Sep 2021

    • Specialist Registration, Follow up& Document Control
      • Jan 2013 - Dec 2015

       Writing, Saving Quality documents related to R&D works. Preparing registration file for (registration, re-registration) process. Dealing with MOH inspector to ensure that all MUP product in conformity with MOH requirements. Preparing CTD file (related to R&D work) for export registration.

    • Specialist Computer& Document Control
      • May 2009 - Jan 2013

      - Writing, saving all R&D documents such as:  Specification, Test method of finished products.  Composition & Master Formula files for all MUP drug products.  Validation Protocol of manufacturing process.  Test Method validation.  Stability (Real, Accelerated Time) Studies. - Writing, Saving Quality documents related to R&D works (eg.: SOPs, R&D core process, ...etc). - Ensure that all computers, printers, Scanners in R&D work effectively - Writing, saving all R&D documents such as:  Specification, Test method of finished products.  Composition & Master Formula files for all MUP drug products.  Validation Protocol of manufacturing process.  Test Method validation.  Stability (Real, Accelerated Time) Studies. - Writing, Saving Quality documents related to R&D works (eg.: SOPs, R&D core process, ...etc). - Ensure that all computers, printers, Scanners in R&D work effectively

Education

  • Suez Canal University
    Bachelor’s Degree, Computer Science
    2003 - 2007

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