Mohamed Abdelhafez

Quality Assurance Specialist at Utopia Pharmaceuticals
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Contact Information
us****@****om
(386) 825-5501
Location
Egypt, EG
Languages
  • English Professional working proficiency
  • Arabic Native or bilingual proficiency

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Credentials

  • Quality Risk Management (QRM)
    Unted State Pharmacobia
    Jul, 2022
    - Nov, 2024
  • Total Quality Management ( TQM ) and Strategic Planning
    Egyptian Syndicate of Scientific Professions ESSP
    Apr, 2019
    - Nov, 2024

Experience

    • Egypt
    • Pharmaceutical Manufacturing
    • 300 - 400 Employee
    • Quality Assurance Specialist
      • Aug 2022 - Present

      • Ensure GMP Compliance for daily activities during batch manufacturing (cleaning, Line clearance, Deviation handling,In‐process quality checks.) • Review each batch record & initiate investigation for observations found in batch records. • Follow-up implementation of CAPAs resulted from failure investigations. • Perform daily rounds in production area and warehouses to ensure implementing GMP during daily activities. • Review and approve Manufacturing and Packaging formula, manufacturing and packaging Instructions. • Review and approve artworks design proofs. • Ensures that all activities in his unit or section are done according the relevant cGMP and ISO standards (ISO 9001, ISO 14001, ISO 45001). Show less

    • Egypt
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Quality Assurance Specialist
      • Apr 2021 - Aug 2022

      Iʼm Responsible for Environmental monitoring, GMP utility systems quality sampling and product sampling management and responsible for Line clearance, In‐process quality checks. Responsible for Review & inspection of primary & secondary packaging materials. Aware of Operating & testing by IPC devices ( Leakage tester – Moisture content – Hardness tester ‐ Disintegration tester – Friability tester ). Participation in Internal and Regulatory audits and assure site readiness for the GMP audits. I Initiate many SOPs in my section and Controlling of the following processing areas: (Dispensing area ,soft gelatin capsules line,Solid line, syrup line , semi solid line ). Follow up all stripping, blistering & packaging processes. Show less

    • Egypt
    • Chemical Manufacturing
    • 1 - 100 Employee
    • Quality Control Specialist
      • Aug 2018 - Aug 2018

    • Egypt
    • Chemical Manufacturing
    • 1 - 100 Employee
    • Quality Assurance Specialist
      • Jul 2018 - Jul 2018

Education

  • Suez Canal University
    Diploma of General Microbiology, Good
    2020 - 2022
  • Al-Azhar University
    Bachelor's degree, Microbiology and Chemistry
    2016 - 2020

Community

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