Quality Assurance Manager

Validation Manager
S
C.V
PERSONAL DATA
Name : Abd El Aziz Ismail Basiouni Badr
Date of Birth : 28/9/1968
Nationality : Egyptian
Address : 2 Abdelrahim Ahmed St.Terat Elkhamasin ST
Elk blat St. El Matria-Cairo-Egypt
Marital Status : Married
Mobile : 01146542754
Email : abdelaziz_ismail968@yahoo.com
EDUCATIONAL DATA
-Secondary School : Elnookraashie secondary school 1986
-University Degree : Bachelor of Science Faculty of Science
Ain Shams University 1990
-Major Grade : Very Good ( Chemistry/Microbiology)

-Diploma in Business administration( From LMDC 2009)

Languages : Arabic-English (Fluent Writing &Spoking)

CAREER RELATED EXPERIENCE

1- May2015-Now
Member of the Registration Review committee(Arab drug
company
2-2012- NOW
R&D Expert(General Manager) of Stability Lab
at ARAB Drug Company
(Approval of the Stability studies of all dosage forms)
(Review &approve all IQ,OQ,PQ Protocoals of All Arab Drug
company Machines)

3- 2009-NOW
Leader &Chief of Cleaning validation technical committee.
(Arab Drug Company)
 4-(2006-2012)
* Manager of Methodology laboratory (central Lab) )
(Arab Drug Company)
-Method development ,analysis, Validation of the method of analysis of
different dosage forms.
ISO 17025 accredited central lab.( 2011 till Now)
5-(2000..2006)
*Analyst in Stability lab.(R&D ) sector(Arab Drug Company)
A-Instrumental analysis of all pharmaceutical products
by different analytical chemical methods(H.P.L.C. ,T.L.C.
Spectrophotometry, Gravimetry,Potentiometry.. etc )
B-Non Instrumental analysis of pharmaceutical products
by different analytical chemical methods
C-Preparing stability studies for the registration of products in M.O.H &other
foreign countries for Exporting .
D- Applying WHO&ICH guidelines and performing all pharmaceutical
analytical testing(Stability indicating assays-Related substance &degradation
tests- Dissolution..etc
6- (1990--------2000)
*Q.C`&Q.A Chemist In- process control- Q.A department
(Arab Drug Company)
-Inspect& check every step in the Pharmaceutical manufacturing process for
the different dosage forms(Aerosols,tablets,Capsules,creams
,oint.,Syrups.etc)
SKILLS
* Managerial skills & TRAINING COURSES
1. G.M.P (WHO)
2. GLP
3. HPLC
4. Evaluation of Stability data (ICH guidelines) training courses
5. Registeration of phramaceutical products training courses
6. Stability indicating assay training courses
7. ISO 17025 training courses
8. ISO 14001&18001 training courses
 9. CTD

10. Leadership Professional Diploma ( Business administration

From( LMDC) ) Grade A March-2009
Leadership & management Grade A
Quality Grade A
Managerial accounting Grade A-
Sceintific research Grade A
Financil managment Grade A
IT Grade A
Marketing Management Grade A
Human resources Grade A
*Computer Skills:
ICDL certificate(15-6-2006)
Windows-MS.(Word-Excel-power point-Access)
Internet
Other Training Skills
-2012-Till Now
Trainer & Instructor in the Training centre of HOLDI Pharma company
For the following training courses
1-GSP
2-Validation of the Methods of analysis(ICH,WHO,USP)
3-Cleaning Validation Program(WHO,)
*INTERESTS
Reading on analytical methods of pharmaceutical product in Analytical
profiles, Pharmacopeia &Analytical Chemistry Science& Internet
Reading on Validation of Chemical analytical methods.
Watching Football games

Other skills
*Good managerial & organizational skills
*Ability to communicate while keeping to the rules
*Ability to work within given timeframe
*Strong attention to details, and ability to multitask
*Ability to sharpen employees' skills without adding extra expenses
 to the organization

* Work Acheivements
1. Design and development of Validation master plan of the Arab
Drug company
2. Validation of the methods of analysis(In-house Methods) for the
Post registered products &New products& application of the forced
degradation techniques to prove that the method is a Stability
indicating assay .
3. Verification of Compendial (Pharmacopeal)methods of analysis
for the Post registered products &New products
4. Designing and development of the Cleaning validation Protocol
SOP as a Cleaning validation leader
5. Application &finishing the Cleaning Validation studies for the
Following Production Departments
Suppositories Department
Aerosol department
Syrup Department
Solid dosage forms departments (tablets &capsules)
Aerosol Department (HFA Products)
6. Designing and development of the OOS &Prospective Validation SOPs
7. Approval of the Stability studies for Registration &Re-registration of
the pharmaceutical products for Local &Export Purposes.
8. Review all Registeration files sent to Egyptian MOH
9. Review &approve all IQ,OQ,PQ Protocols of All Arab Drug
company Machines(Solid dosage forms production machines,Liquid
dosage forms production machines)