I am extensive experience in quality assurance and regulatory affairs work environment, superior expertise in biological, pharmaceutical, food and cosmetic products regulation and manufacturing.
Place of Birth: Giza, EGYPT.
Date of Birth:11/9/1978.
Marital Status: Married
Address: ELmostkpel faisl, marioyteya Giza, EGYPT.
Work Address: Nasser city, cairo,EGYPT.
-B.Sc. pharmaceutical Science 2003, Faculty of pharmacy, EL AZhr University, Cairo,
Very good grade.
From 5/2004 -5/2005: pharmacist at ELSaf centralHosipital
From5/2005-2009: packaging exportation supervisor at vacsera
From 2009/2011: quality assurance supervisor at productive store, warehouse and media plant.
From 10/2014-4/2015: in process quality supervisor at B#1 plant for filling of sterile products &process valdation.
From 4/2015_4/2017: in process quality manager at quality control labs &stability lab and regulatory affairs supervisor at vacsera .
Inspection committee manager of raw materials and participate in release its final certificate and regulatory affairs supervisor at vacsera.
4/2017-10/2017: quality and regulatory compliance consultant at MUP for pharmaceutical products (veterinary medicine)
10/2017 till 03/2018: quality assurance manager at B#60 for production and filling of sterile products (sera&vaccine) and deputy of regulatory affairs manager at vacsera .
-Deputy of regularity affair manager at vacsera start from 03/2018 till 9/2018
-regulatory affair manager and quality compliance at Egyptian Canadian company and megamed for toll manufacturing 9/2018 till 03/2019
Quality assurance manager at sigma for pharmaceutical industry start from
03/2018 till 10/2019
Quality director and regulatory affairs manager at soficophharm
Start from 11/2019 ( current position )
-Good Manufacturing Practice “GMP”, and in Holding company for Biological Products & Vaccines (VACSERA), in the period from 27/5/2004 to 27/6/2004.
-Training program with a title of (Anti body production, purification and application) from 11-1-2009 to 15 -1-2009, VACSERA, Egypt.
-Total Quality Management 2012
-Water Measurements for Medicines 27/11/2012
-Quality Control and Quality Assurance ( VACSERA) 2009
-Principles of good manufacturing practice GMP and total quality management TQM(Egyptian -international group) at 7/6/2015
-WHO training program with a title of biosafety and biosecurity.
-Leadership training course
-Audit training course
-TQM and ISO 9001/2015.
Glp training course
Hplc training course.
-environmental monitoring program training
- Warehouse and inspection of raw materials training
- Stability study program training
- sampling method training
- OOS and OOL and OOT training
Cleaning technology and its validation.
-Ctd,e ctd course
-Pharmacovigilance course introduction from UPSLA-WHO
-Signal detection and causality assessment (UPSLA-WHO)
-Statistical reasoning and algorithm in Pharmacovigilance (UPSLA-WHO)
-Process and analytical method validation training
- Computer system validation WHO
- Pharmacovigilance system master file (PSMFs)&(PSSFs),inspections and Pharmacovigilance audits (certified from VigiHub Amr Saad )
-GMP professional certified course.
-A SM (American society of microbiology) certified .
-Data science and data analysis course.
-International business driving licence (IBDL)