Yahia Elmasry
CTD section head at Utopia Pharmaceuticals- Claim this Profile
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English -
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Arabic Native or bilingual proficiency
Topline Score
Bio
Experience
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Utopia Pharmaceuticals
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Egypt
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Pharmaceutical Manufacturing
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300 - 400 Employee
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CTD section head
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Oct 2021 - Present
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Medical Union Pharmaceuticals
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Senior Registration, Follow up& Document Control
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Jan 2016 - Sep 2021
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Specialist Registration, Follow up& Document Control
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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.
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Medial Union Pharmaceutical Company
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Ismailia, Egypt
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Specialist Computer& Document Control
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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
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Education
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Suez Canal University
Bachelor’s Degree, Computer Science