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Ghada Mohamed Fahmy

GMP Compliance Supervisor at VACSERA

Hadayek Alahram, Giza, Egypt

Work Experience

  • GMP Compliance SupervisorFull Time

    VACSERA

    Jun 2022 - Present -3 yrs, 1 month

    Egypt , Giza

    • Job Details:Compliance follow in the vaccine company ,preparing and revising all documents needed for routine works and audits. Preparing CAPA for audits and using process improvements tools. Investigate complaints and apply internal audits map and self inspection. Apply company mission and vision to achieve goals

    • Sedico

    • Quality assurance specialist at Biotechnology sterile production lineFull Time

      Mar 2017 - Mar 2019 -2 yrs

      Egypt , Giza

      • Job Details:Fully responsible of quality and GMP compliance for biotechnology sterile production line through my team and follow up the following - Follow up production lines of following products Insulin,Epoetin ,Sedonase and Filgrastim. - Attending Preparation process. - Follow up filling of sterile area &all aseptic conditions of biological products and IPC samples. - Follow up Sterilization:Operating autoclave,inspect charts and organizing loads. - Check the BMS charts. - Reviewing batch production record. - Auditing & self inspection. - Reviewing environmental monitoring of sterile area class A&B. - Deal with MOH auditors. - deal with outside auditing. - Carefully review manufacturing, packing, sterility, QC and monitoring files to approve release of batches. - Recording, analyzing and distributing statistical information. - Performs the protocol of media fill, deviation , risk assessment, change control report and investigation reports. - monitoring performance.

    • Quality Control Biotechnologist at ISO/IEC 17025 Biotechnology LabFull Time

      Aug 2016 - Feb 2017 -6 months

      Egypt , Giza

      • Job Details:- Performs wet and instrumental analysis( HPLC, UV, ELISA, Capillary Electrophoresis, PAGE) of raw materials, in process and finished products. - Performs all Biological and chemical analysis of stability method for finished products. - Troubleshoots and resolves operations issues. - Prepares, standardizes and maintains availability of refernce standards, volumetric solutions, glassware,reagents and ensures their good handling and storage according to ISO/IEC 17025 and the approved SOPs - Validation of the assay methods of finished products. - participates in Validation and manufacturing processes.

  • Biotechnology InstructorFull Time

    Egypt Biolabs EBL

    Oct 2015 - Jul 2016 -9 months

    Egypt , Cairo

    • Job Details:- Organizer and instructor (practical part) for Genomics, Proteomics, Stem Cells and Molecular biology workshops.  - Admin for Egypt Biolabs EBL  facebook page.

  • Biotechnology SpecialistPart Time

    OMICS Egypt for Molecular Biology and Stem cell

    Jun 2012 - Sep 2015 -3 yrs, 3 months

    Egypt , Cairo

    • Job Details:Molecular biology techniques in Animal Genetics and Molecular Virology: - DNA, RNA, micro RNA Bacterial Extraction. - Conventional PCR and Real Time PCR Techniques - The enzyme-linked immunosorbent assay (ELISA) Techniques - Dialysis Techniques - Isolation of stem cells - Microbiology Techniques - Gel Electrophoresis for protein and Nucleic acids - Tissue Culture Techniques - High Performance Liquid Chromatography (HPLC)

    • Education

    • Master in Quality managment

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

      Jan 2017 - Jan 2019 - 2 yr

    • Bachelor's Degree in Biotechnology and molecular biology

      Cairo University (CU)

      Jan 2016 

    • High School - Other

      Om El Abtal Secondary School

      Jan 2012 

    Achievements

    I have a lot of awards in swimming and basketball sports.

    Skills

    Languages

    • Arabic

      Fluent

    • English

      Advanced

    Training & Certifications

    • 4) Risk management. 5) process & cleaning validation. 6) ISO/IEC 17025 . 7) ISO 9001. 8) HPLC(Shimadzu LC 20 and Agilent 1200) , ELISA, Capillary Electrophoresis ,UV and PAGE techniques.

      ASEC for training and consulting, SEDICO Company:·2017

    • 1) Good manufacturing practice (cGMP). 2) Good documentation practice (GDP). 3) Quality by design (QBD).

      ASEC for training and consulting, SEDICO Company:·2017

    • Measuring the cytotoxic effect of novel compounds on different human cancer and normal cell lines. Won 1st place in the best graduation project competition

      Cairo University.·2016

    • Course Instructor of Genetic engineering to spread awareness about scientific research.

      Genius language school·2016

    • Organizer of training course proteomics: Drug target and biomarkers discovery

      Faculty of Veterinary Medicine Cairo University.·2016

    • Organizer and instructor of the workshop: Stem cells isolation and applications

      Omics Company·2015

    • Organizer and instructor of the workshop: Genomics and Proteomics

      Omics Company·2015

    • pharmaceutical quality assurance and quality control Trainee .

      Kahira Pharmaceuticals and chemical industries Company·2015

    • Organizer and instructor of the workshop: polymerase Chain Reaction (PCR) as a diagnostic tool, at Center Excellence For Scientific Research.

      Benha University, faculty of Veterinary Medicine·2015

    • Organizer and instructor of the workshop: Stem Cells Applications in Scientific Research.

      Omics Company·2015

    • Organizer and instructor of the workshop: Applications of Genetic Engineering,

      2014

    • Participated in the (Biofans) conference vol 3.

      Cairo univerisity·2014

    • Organizer of The 11 th annual congress of medical sciences medical research between theory and application :challenges and innovation,

      NRC, Cairo-Egypt.·2013

    • Organizer of 2nd symposium (soul) for Biotechnology Program .

      Cairo university·2013
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