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Regulatory and quality manager

Location:
Giza, Giza Governorate, Egypt
Posted:
March 20, 2020

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Resume:

Summary :

I am extensive experience in quality assurance and regulatory affairs work environment, superior expertise in biological, pharmaceutical, food and cosmetic products regulation and manufacturing.

Personal Details:

Place of Birth: Giza, EGYPT.

Date of Birth:11/9/1978.

Nationality: Egyptian.

Marital Status: Married

Address: ELmostkpel faisl, marioyteya Giza, EGYPT.

Work Address: Nasser city, cairo,EGYPT.

Mobile: 012********

E-mail: adcdtu@r.postjobfree.com

Qualifications

-B.Sc. pharmaceutical Science 2003, Faculty of pharmacy, EL AZhr University, Cairo,

Very good grade.

Work Experience:

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 )

Training Courses

-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.

-Risk assessment

Glp training course

Hplc training course.

-environmental monitoring program training

- Warehouse and inspection of raw materials training

-media preparation

- Stability study program training

- sampling method training

- OOS and OOL and OOT training

-Pharmacovigilance 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

- GDP&GSP

- 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)

ASMAA HUSSIEN



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