Mohammed Helmy Email and Phone Number

Education: B.Sc. of Pharmaceutical Sciences, Faculty of Pharmacy, Cairo University, 2012Working Experiences:❖ Jan 2020 till presentQA Senior officer works as Batch release with all tasks of Batch release: o Reviewing BRs.o Follow up of any related Deviations, Incidents, Change controls, OOS and Complains.o Releasing batches on SAP system.o Archiving BRs for easy retrieval.❖ December 2016 till Jan 2020:QA Senior officer works as Site regulatory officer (SRO) at HIKMA Pharma Egypt inaddition to other assigned tasks e.g:o QA team training fileso APRo BRs reviewal• Responsibilities in HIKMA as SRO are as follows:o Prepare all the required documents (PBRs - COAs - Registration license - etc...) forMOH inspector weekly visits.o Organise all activities and work done during the MOH inspector visits.Prepare samples to be withdrawn by the MOH inspector including (random withdrawal, Tender, New supplier or composition, etc...) either for (Local, imported, FMS or food supplement products), send it to NODCAR and paying fees.o Follow up for withdrawn batches/ lots conformities with NODCAR.o Inform all factory departments (production, R&D, QC, Purchasing, Planning, WH) about MOH new decisions, regulations and inquiries to maintain compliance with MOH decrees and initiating CCRs if required.o Ensure regulatory compliance i.e. all actual products specifications are complying with MOH registered specifications.o Follow up the status of registration of all new products with regulatory affairs dept. & the MOH inspector.o Follow up implementation of steps & regulations required in case of (reregistration of a product, registration of new supplier, new composition or new batch size etc… for a pre-registered product.o Coordinating MOH audits on site.❖ February 2016 till November 2016:Quality Assurance officer (IPC) at HIKMA Pharma Egypt.• Responsibilities in HIKMA as QA Officer are as follows:o Perform a daily tour in all manufacturing areas inside the site to ensure cGMP regulations & all SOPs are well implemented.o Do IPC (In process control) checks and acceptance samples for all processes done during manufacturing.o Prepare daily, weekly and monthly report on all issues concerning quality and performance of production department and suggested solutions for that.June 2014 till Jan 2016:Quality Assurance officer (IPC) at FPI (Future Pharmaceutical industries).