Mohamed Ibrahim Kamal Personal Information

Address : 6th October , Giza , Egypt .

Mobile No. : ( 002 ) 01009017191 , 01022455576 .

Telephone No. : ( 002 ) 0503825382 .

Date Of Birth : 01/06/1985 .

Gender : Male .

Nationality : Egyptian .

Marital Status : Married .

Military Status : Exempted .

E-Mail : Dr_Mk1000@yahoo.Com .

Education

7 – 2007 , Bachelor Of Pharmaceutical Science .

Faculty Of Pharmacy : Mansoura University .

Grade : Very Good .

Professional Training

Courses In cGMP , Documentation , Safety and GLP . ISO 19001 : 2008 , ISO 14001 : 2004 , OHSAS 18001 : 2007 & ISO/IEC 17025 : 2005

CTD & eCTD

Subjected To & Passed International Quality Audit :

Novartis Pharma & GSk Consumer Health

Janssen Pharma.

Mepha International , Switzerland

Schering – Plough Corporation , USA.

Pharmaceutical Industry Experience

Working at AUG Pharma , 6th October , Giza From 5 / 2013 till now (Quality & Validation Section Head ). Working at EIMC UNITED PHARMACEUTICALS ( EUP ) , Badr City, Cairo From

1/ 2011 till 4/2013 ( Validation Supervisor ).

Working at Medical Union Pharmaceuticals ( M.U.P), Abo Soltan , Isamalia From 9 / 2007 till 12/2010 ( Validation Specialist ).

Skill Summary

1-Process Validation : Prepare Process Validation Protocol & Report Determine Critical Process Steps & CPPs Risk Analysis of Manufacturing Process Steps Determine Sampling Plan Determine Validation Acceptance Criteria & Process capability

2-Cleaning Validation : Prepare Cleaning Validation Protocol & Report . Calculate MACO Choice Of Worst Case Sampling Plan Chemical & Microbiological Acceptance Criteria Of Swab & Rinse For API &

Cleaning Agent Determine Recovery Percentage , LOD & LOQ Determine Clean Hold Time & Dirty Hold Time . Determine Campaign length Time.

3-Media Fill For Vial and Ampoule Processing Line : Prepare Media Fill Protocol & Report Monitoring of Media Fill Operation Make Routine And Non Routine Interventions

4- Review Analytical Method Validation Protocols & Report

5-Thermal Validation Depyrogenation &Sterilization Tunnel (Heat Distribution and Penetration) Depyrogenation & Sterilization Oven (Heat Distribution and Penetration) Steam Sterilizer(Autoclave) (Heat Distribution and Penetration) Incubators , Cold Store , Climatic Chamber & Lab. Refrigerator (Heat Distribution

and Penetration) Warehouse Thermal Mapping Use Kaye Validator 2000 Use Testo Data Loggers

6- Installation & Operational Qualification For : Diosana Granulation Line Muller & Bohle Blender Fette & Sejong Tablet Press MG2 , Pam & Bosch Capsule Filling Diosana & Sejong Coater Uhlman Blister Machine Aqua Italy & Techninox Liquid Preparation Tanks Bousch Strobel & Yoosung Bottle Blowing , Filling , Capping & Labeling Machine

7- Water System Validation (Christ Aqua Italy & Stilmas ) : IQ & OQ Performance Qualification ( Phase 1 , 2 and 3 )

8- Pure Steam Quality Tests Non Condensable Gases , Superheat & Dryness Value . Use Steam Quality Kits

9- Clean Room Validation & HAVC System Qualification SAIVER AHU , Tanta Motors Exhaust Fan & Munters Dehumidifier IQ , OQ Ampoule , Vial, B-Lactam And Cephalosporin Sterile Areas / Solid, Semisolid &

Liquid Dosage Forms Manufacturing Areas Performance Qualification HEPA Filter DOP test by ATI Aerosol Photometer / Aerosol Generator HEPA Filter Air Velocity Test by Testo Anemometer Diffuser Air Flow Rate Test by TSI Capture Flow Hood Room Air Change / Hr Room Air Pressure Difference Test by Manometer Airborne Particulate Count Test by Metone Particle Counter Review Viable Particle Count by Eco Air Sampler , Settled Plate

10- Compressed Gases ( Air & Nitrogen ) Generators Qualification Atlas Copco Air Compressor and Dryer IQ & OQ INMATEC Nitrogen Generator IQ & OQ Air Compressor & Nitrogen Generator PQ By Dräger Alpha Aerotest & Laser Particle Counter according to ISO 8573-1 Compressed air Oil Content Compressed Gases CO2 , CO & H2O content Non viable particulate matters Review Viable Count

11- Computer System validation : Dynamics AX 2009 ERP Validation BACStage Building management System Software Validation Lab. Excel Spreadsheets Validation

12- Physical calibration Temperature sensors by fluke kaye dry well ( LTR140 & HTR400 ) and testo

reference thermometer Temperature & humidity sensors by testo thermo hygrometer Absolute pressure indicators and transducers by druck pressure calibrator Differential pressure gauges by dwyer manometers Speed meter / RPM by tachometer Pharmaceutical & analytical balances by traceable standard weight set ( E2 , F1 &

M1 )

13- Check External Physical Calibration & Validation Activities Executed by External Agency

As (Akhanton , EES, karma & Elmehy)

14- Check Calibration of lab. Instruments HPLC GC U.V Spectrophotometer IR Spectrophotometer Dissolution Tester Disintegration Tester I.R Moisture Analyzer Hardness Tester Friability Tester Conductivity Meter pH Meter Polarimeter Potentiometer Melting Point Tester Viscometer Torque Tester

15- Supervision the control of All Documents: VMP ( Validation Master Plan) SMF ( Site Master File ) QM ( Quality manual ) MBR & PBR ( Manufacturing & Packaging Batch Record ) SOPs & Procedures Distribution , Cancellation & periodic List

16- Risk Management process Owner : Handling of Raised Risk Assessment Form Coordinate Risk meetings Register the approved risks Raise risk control & review Form Follow up the actions required to eliminate , reduce & accept Risk

17- Handling of Deviations & Change Control

18- Site regulatory Issues : Handling of raw material & finished product samples delivered to MOH for

Registration & Inspection Reason Handling of complementary letters related to NODCAR analysis Handling of product master file which contain registration documents & studies

approvals Prepare CTD & eCTD file for tablet & liquid products

19- Internal Auditor : Coordinate with all departments for preparation for the following external audits : Novartis Pharma GSK Consumer Health Janssen Pharma ISO 19001 : 2008 ISO 14001 : 2004 OHSAS 18001 : 2007 ISO/IEC 17025 : 2005