1. PAGE 1 OF 3 V#06
Mob. +201119065833- 01013007764
E.MAIL:CALVAL2006@GMAIL.COM
M A H M O U D S A L E H M A H M O U D
WORK EXPERIENCE
5/2008- till now Eimc United Pharmaceutical (EUP) Badr City – Egypt
(EUP Became Certified From EMA (European Medicinal Agency) To Export Sterile
Oncology & Non-Oncology Products to Europe, Since 6-2011- Certificate #3243).
Validation Section Head– Quality Assurance
 Participate in making Supplier evaluation program and in making auditing on
suppliers (Raw Materials and packaging materials) inside and outside Egypt
{Auditing DONGA-A Company (APIs manufacturer -South Korea)}.
 Present a presentation about the qualification procedures of
the depyrogenation process in seminar organized by AUPAM & P.C.A in Egypt.
 Establishing all validation documents in the factory e.g. VMP, Validation SOPs,
Qualification Protocols (IQ, OQ & PQ) and Validation Protocols (Cleaning &
Process), to comply with the EU GMP Annex 15 requirements and all other
validation regulations.
 Prepare the risk assessment reports according to the EU GMP annex 20 and ICH
Q9 guidelines.
 Prepare and execute of different Qualification Protocols{such as Utilities (HVAC
System, Water System, Steam Generators, Compressed Air System & N2
Generator), Sterile Production Machines (Autoclaves, Tunnels, Vial/Ampoule
Washer, Filling, Crimping, Preparation Tanks & CIP/SIP System), Syrup
Production Machines (Preparation Tanks, Washing, Filling and Capping
Machines), Solid Production Machines (Granulation, FBD, Blending, Capsule
Filling, Compression, Coating & Blistering Machines), Computer System
(SCADA System and BMS)& QC Equipment ( Incubators, Ovens, LAFs, BSC,
Disillusion, friability, Hardness, Disintegration Testers, Stability Chambers,
Balances, UV, HPLC, IR & GC)}
 Prepare and execute of different Validation Protocols (such as Cleaning
Validation (CV) protocols and reports of all production machines/ equipment &
Process Validation Protocols of different dosage forms).
 Investigating all deviations and /or failures, change controls during the
qualification /validation activities and follow-up of the implementation of all
required corrective actions.
 Validate storage conditions for materials and products (Such as prepare and
execute the Temperature and % RH Mapping study protocols).
 Establishing all Calibration documents in the factory (e.g. Calibration
management program, Plans, SOPs & Certificates) and execute calibration
activities of all equipment, such as (Temperature sensors, Pressure
gauges/Transmitters, Balances & R.P.M).

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 Establishing the Validation and Calibration Laboratory in the factory which
including all reference instruments required for calibration and qualification
activities (such as HVAC & Clean Rooms certification reference equipment (Air
velocity meter, Air Flow Hood, Differential Pressure Meter, Aerosol Photometer
and Generator, Airborne Particle Counter, Air Current Tubes), Reference
Equipment for Thermal devices qualification (KAYE Validator System), Steam
Quality Test Kits (For Non-Condensable Gases, Dryness Factor & Superheat
Tests) and Pharmaceutical Gases Test Kits)
8/2005 – 5/2008 Egyptian Company for chemical & pharmaceutical
(ADWIA) 10th Ramadan City - Egypt
Validation Supervisor – Quality Assurance
2003 – 2005 VACSERA Cairo , Egypt
Validation specialist in Meteorology and Validation Labs - Quality
assurance
 Acting as a team leader in the Thermal Lab. using Kaye Validator System
o Perform all Thermal qualification/validation activities (Heat distribution &
Heat penetration studies) for all thermal devices ( Autoclaves – Tunnels –
Ovens – Incubators - Cold rooms – Deep freezers ….etc)
 Acting as a team leader in Clean Room validation labs using all clean rooms
validation instruments to perform all clean rooms certification tests according to
ISO 14644 , Federal standard No. 209 B , Annex 1 sterile manufacturing-EU
GMP and FDA Sterile Guidance 5882fnl
 Review and execution of all validation protocols (IQ,OQ&PQ) and acting as
representative in validation of HVAC system ,sterile liquid filling line (BOSCH
line, washing machine ,tunnel, filling machine and Crimping machine) ,Path
boxes between different classes, Autoclaves, …etc).
 Acting as a team player in the weighing, volumetric, and mass labs. to calibrate
balances and micro pipettes.
 Acting as a team player in photometric lab. to calibrate spectrophotometer
instruments in VIS range.
TRAINING COURSES
2003 ( NIS ) Cairo, Egypt
 Calibration of thermal devices
2004 (NIS) Cairo, Egypt
 Calibration of electronic balances and micropipettes
2004 VACSERA Cairo, Egypt
 Treatment of biological waste
2004 VACSERA Hilton Ramsis , Cairo , Egypt
 Pharmaceutical &Biopharmaceutical compliance summit by the pyramids
2005 ADWIA 10th Ramadan City - Egypt
 EU GMP Training Course

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2008 EUP Hilton Ramsis, Cairo, Egypt
 Design, Construction and qualification of pharmaceutical clean room
systems for optimized contamination control.
2012 -2013 EUP
 Computer System Validation, GAMP®5 SONESTA Hotel, Cairo, Egypt
 Stability Studies and Validation AUPAM, Cairo, Egypt
 Risk Based Modern Cleaning Validation Le-Passage Hotel, Cairo, Egypt
2014 EUP
 Computer System Validation Work-Shop Concorde El Salam Hotel, Cairo,
Egypt
EDUCATION
 2001 – 2002 Faculty of Science- Special Chemistry , Zagazig university
, Egypt
SKILLS
Computer Skills
Microsoft Word
Power Point
Internet
Microsoft Excel
Other Skills
Presentation Skills
Communication Skills
Proficiency
Excellent
Excellent
Excellent
Good
Excellent
Excellent
LANGUAGES
Language
Arabic
English
Proficiency
Mother language
Very good
PERSONAL INFORMATINS
Date of birth
Religion
Marital Status
Military Status
Living Address
12-4-1977
Muslim
Married
Completed
10th of Ramadan City
REFERENCES
Furnished upon request