
MOHAMED KHIDR ARAFA
Stability and Methodology Section Head at Atco Pharma For Pharmaceutical Industries
Mahalla Kubra, Gharbia, EgyptWork Experience
Stability and Methodology Section HeadFull Time
- 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
- 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
- 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 UniversityJan 2009 - Jan 2010 - 1 Year
BSc in science
Mansoura UniversityJan 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
Languages
Arabic
FluentEnglish
Advanced
Training & Certifications
Conformity assessment principles of ISO 9001/2015 and ISO 17025
EDA Training program by (Dr. Tarek Refaey).·2022completing (AN overview of pharmaceutical impurities according to ICH Q3 A, ICH Q3B, ICH Q3C, ICH Q3D, ICH M7, ICH Q9 & pharmacopeial requirements)
EDA·2022completing (validation, verification and Transfer of analytical procedures, Aug. 2020) webinar
USP·2021Quality files (Module 3 of the CTD Files) Guidelines and Submission Guidance
Egyptian Drug Authority·2021Famirilization and operation of "Agilent HPLC 1200 and 1260" Chemstation and Software.
Agilent·2020ICDL
Mansura University·2009ICDL
Mansura University·2009