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MOHAMED KHIDR ARAFA

Stability and Methodology Section Head at Atco Pharma For Pharmaceutical Industries

Mahalla Kubra, Gharbia, Egypt

Work Experience

  • Stability and Methodology Section HeadFull Time

    Atco Pharma For Pharmaceutical Industries

    Aug 2014 - Present -10 yrs, 11 months

    Egypt , Monufya

    • Job Details:Head of Methodology and Stability Department with more than 12 years of experiences gathered from different companies with different cultures, with excellent knowledge of all relevant issues with stability and methodology requirements and with relevant interested parties such as (EDA, CAPA, stability committee, Bioequivalence committee and CADC).
  • Quality Control SpecialistPart Time

    Pfizer

    May 2014 - Jul 2014 -2 months

    Egypt , Cairo

    • Job Details:* Responsible for developing new methods of analysis and performing routine analysis of four human pharmaceutical products at Pfizer as well as solving their analysis problems.
  • Stability and Methodology seniorFull Time

    Saja Pharmaceuticals Egypt

    Mar 2014 - Aug 2014 -5 months

    Egypt , Cairo

    • Job Details:* Responsible for performing stability studies and NODCAR file completing all of its files according to the latest ICH guidelines. * Responsible for making new methods of analysis for new FPP with all of its dosage forms. * Implementation of the cGMP, ISO FDA, ICH, EDA, WHO, EMEA, VICH and the other agencies requirements in R&D department. * Responsible for performing all stability and Methodology duties and routine work. * Generate, review, and approve all supporting document including protocols, reports, test methods, specifications, OOS reports and other in support of the ANDA and NDA filing.
  • Quality Control Analyst promoted to SeniorFull Time

    SABAA Pharmaceuticals

    Oct 2010 - Mar 2014 -3 yrs, 5 months

    Egypt , Kafr Alsheikh

    • Job Details:* Perform routine chemical testing of commercial, validation and stability samples. * Perform qualitative and quantitative analyses using analytical instrumentation such as (HPLC, GC, UV/Vis, KF, FTIR) and other chemical lab instruments. * Analyze data against approved specifications, notifying management of any OOS and aberrant results. * Actively participate in root cause problem solving during laboratory investigations, provide. input for effective corrective and preventative actions. * Responsible for making Standard Operating Procedures (SOP). * Responsible for Calibration and verification of all of Q.C. instruments.
  • Education

    • Total Quality management (QMS) in quality management

      Arab Academy for Science, Technology and Maritime Transport (AAST)

      Jan 2022 - Jan 2024 - 2 yr

    • Technical Diploma in analytical biochemistry

      Menoufia University

      Jan 2009 - Jan 2010 - 1 Year

    • BSc in science

      Mansoura University

      Jan 2005 - Jan 2009 - 4 yr

    Achievements

    - Have the honor for my achievements to obtain a recommendation letter from Dr. Rania Aziz Ishak, Professor of Pharmaceutics and Industrial Pharmacy, Manager of Experiments & Advanced Pharmaceutical Research Unit (EAPRU), Faculty of Pharmacy, Ain Shams University, Cairo, Egypt. - Have the honor for my achievements in the Company to be promoted to Veterinary Products Project Manager from January 2022 till now in addition to my Position as R&D Section Head

    Skills

    • Project Management
    • Analytical Chemistry
    • R&D methodology
    • Pharmacy
    • Team Leadership
    • Time Management

    Languages

    • Arabic

      Fluent
    • English

      Advanced

    Training & Certifications

    • Conformity assessment principles of ISO 9001/2015 and ISO 17025

      EDA Training program by (Dr. Tarek Refaey).·2022
    • completing (AN overview of pharmaceutical impurities according to ICH Q3 A, ICH Q3B, ICH Q3C, ICH Q3D, ICH M7, ICH Q9 & pharmacopeial requirements)

      EDA·2022
    • completing (validation, verification and Transfer of analytical procedures, Aug. 2020) webinar

      USP·2021
    • Quality files (Module 3 of the CTD Files) Guidelines and Submission Guidance

      Egyptian Drug Authority·2021
    • Famirilization and operation of "Agilent HPLC 1200 and 1260" Chemstation and Software.

      Agilent·2020
    • ICDL

      Mansura University·2009
    • ICDL

      Mansura University·2009
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