mennat-allah maklad

qa section head

About

With my 8 years of experience in the pharmaceutical industries, awareness of different manufacturing guidelines such as ISO 9001, GMP (WHO, Eudralex, FDA, PIC/s and ICH), TQM diploma from the AUC, and ongoing pharmaceutical industries' MSc degree from the University of Manchester, my objective is joining the Quality Assurance team of a major Pharmaceutical or FMCG organization where I could further improve my skills and technical knowledge, utilize my experience and energy to make a positive difference in the community.

Country

egypt

City

egypt

Industry

pharmaceuticals

Skill

regulatory affairs, teamwork, pharmaceutical industry, gmp, research, pharmaceutics, sop, microsoft office, english, quality assurance, validation, microsoft excel, fda, market research, ectd, project planning, event management, analysis, public speaking, medicinal chemistry, pharmacology, drug development, quality control, glp, quality auditing, powerpoint, pharmaceutical research, capa, management, ema, corrective and preventive action, cross functional team leadership, design thinking, team leadership, peer mentoring, iso 9001, quality system

Experience

qa section head

hochster pharmaceutical industries

2019-1 - Present · 7 yrs 9 mos

qa supervisor

hochster pharmaceutical industries

2016-7 - 2018-12 · 2 yrs 6 mos

ayb-guc president

ayb

2010-1 - 2011-7 · 1 yr 7 mos

qa specialist

hochster pharmaceutical industries

2014-1 - 2015-1 · 1 yr 1 mo

regulatory affairs specialist

hochster pharmaceutical industries

2011-11 - 2014-1 · 2 yrs 3 mos

* Submitting all required documentation for Hard Files and following up till getting the final license. * Editing and translation of EMC/ FDA insert leaflets and approving them by CAPA. * Following up with NODCAR for product analysis. * Designing and editing of drug packaging according to the regulations of CAPA. * Updated with FDA/ EMA/ Rote Liste and checking the daily drug approvals. * Writing brief scietific research about the potential molecules that can be added to the company's products. * Preparing a primary market study for potential molecules that can be added to the company's products. * Submitting and following up with stability files. * Preparing Drug Soft files * Good knowledge of the eCTD system.

science committee newsletter teamleader

british council

2008-8 - 2009-1 · 6 mos

1- Responsible for reviewing and approving scientific articles written by team members. 2- Ensure optimum communication between the newsletter team and other teams in the committee

senior qa specialist

hochster pharmaceutical industries

2015-1 - 2016-7 · 1 yr 7 mos

* Review batch manufacturing and packaging records. * Revising packaging materials. * Creating APRs for different products manufactured by Hochster. * Preparing retrospective process validation protocols. * In cases of failures, implementing and following-up documented corrective actions. * Writing and updating QA SOPs * Being the pharmacist responsible for narcotics dispensing; dispensing narcotic raw materials in the attendance of the MOH representative, and following-up the narcotics batch records revision.