Page 1 of 7

Seeking a challenging position in Q.A management field utilizing my qualifications, offering

excellent work efficiency ,enriching my experience ,creatively ,translating ideas and maintain
continuous improvement through work flow.





! Diplome of T.Q.M (Total Quality Management)
Arab Academy for Science and Technology
Excellent - G.P.A 3.72
! Diplome of Project Management
Cambridge Training College
INTERNATIONAL CERTIFICATE NO: 25032010220
! Diplome of Human Resources Management
Cambridge Training College
INTERNATIONAL CERTIFICATE NO: 25032010221
! B.Sc. in pharmaceutical science
Tanta University, Faculty of Pharmacy, Egypt
Graduation grade/year: Good/2007
Ahmad Gamal Azzam-
Cell: +20-100 232 0381
+20-1129611122
E-mail: dr.3azzam@yahoo.com

EDUCATION & QUALIFICATIONS

OBJECTIVE
PART A
Page 2 of 7











































Arabic : Mother tongue
English : Very good command of spoken and written

1. SCM - Supply Chain Management Course 2014
2. Crisis and risk management 2013
3. Root Cause / Corrective Action Course 2013
4. Calibration Course In The Field Of Temp ,Pressure, Weights & Length 2013
5. Quality/Environmental Management Systems Auditing 19011:2002 2013
6. GLP 40 CFR Part 160 2013
7. EMA Sterile Manufacturing 2013
8. GMP Of Sterile Manufacturing Eudralex 2012
9. WHO cGMP Regulations 2012
10. Leadership , Motivation & Team Building 2012
11. Level 5 English Course 2011
12. FDA cGMP Course - 21 CFR Part 210&211 2010
13. Fire Fighting 2009
14. Train Of The Trainer Certificate 2008
15. Sops Writing Course 2008
16. Organizational Behavior 2008
17. Time Management 2007
18. First Aid 2007
19. NLP (Neuro-Linguistic-Programming) 2005
20. Windows Xp & Ms Office 2003 2004




CERTIFICATES & COURSES
Languages
Page 3 of 7





Employer Title Time period
ATOS-PHARMA QA General Manager Nov 2013- present
Three Plants/factories; 1-Pharma 2- Extraction (API) 3-Herbs
Certified : ISO 9001, 17025 , 14001 , 18001
Quality agreement with SANOFI for 12 products manufacturing at Atos ( in progress )
Employer Title Time period
EUP-Eimc united Head of Compliance (Sterile) Oct 2012-Oct 2013
EMA approved for sterile oncology manufacturing
Two sterile areas ( oncology {European} and non oncology products)
solid manufacturing area and syrup manufacturing area.
Employer Title Time period
SIMCO Medical Products QA manager Mar 2012-Oct 2012
Building and preparing QA system from the scratch to be certified as
a cephalosporin Products manufacturer. (Company was liquidated)
Employer Title Time period
ATCOPharma
QA Section Head
(act as QA manager)
Oct 2010-Mar 2012
Start Up From The Scratch
QMS ,HVAC , water station IQ,OQ ,PQ
Other Qualifications , Validation (process & cleaning ) - Products Registration & transfer follow up
Employer Title Time period
SIGMA
! Q.A I.P.C sr. officer
! Production Specialist
Aug 2007- Oct 2010
Q.A sr. officer:
Solids Department (Preparation, compression, caps. & sachets filling, coating, blistering & packaging)
Production Pharmacist: in preparation and packaging of syrups , semi-solids & softgelatin.

Instructor / Trainer
Technical Instructor: at Sigma ,Simco , Eimc & Atos companies
Fields : cGMP ,Cleaning validation , Documentation ,Quality management & sterile manufacturing
Freelance Trainer: conducting sessions in leadership, human development and soft skills,
handling most of the training activities such as designing courses, preparing material, presentations,&
leading different training methodologies
(Lecturing - Role Plays - Case Studies - Brainstorming - Games - Individual/Team Exercises).
Employment History
Page 4 of 7




Highly Dynamic ,innovative with excellent Leadership skills & Ability to work under
pressure and for long time alone, never give up, with proven communication & negotiation
skills at all managerial levels, eager to learn supported by broad & professional knowledge,
background & capabilities.

Date of birth: 23/7/1981 Marital status: married
Military status : exempted
Residency : 10
th
of Ramadan district 25 building No.42/3 flat 5
Other residency : 6
th
October district 8
th
building No.99 flat 404




Problem solving Decision making
Psychology, Psychotherapy & Human behavioral study



Advanced user of windows XP ,7 and their applications
Advanced user of internet and networks
Very good user of Microsoft office
Good user of MS-project
Solid back ground about graphics & flash making apps; (photoshop & poser 4 )
Basic knowledge about programming, cracking & systems hacking.



Passing CMQ/OE exam ( at 3/2015 )



! Dr.Hisham Kamel Plant general manager Atospharma
01280555751
! Dr.Hussain El Dars-Technical director- Sigma 01223338594
! Dr.Omyma Noreddin- QA manager-Sigma 01222474120
! Dr.Hammam Habshout Plant manager at Pharma-med 01120044887
! Dr.Foad Mohyeddin- vise production manager -Sigma 01008001062
! Mr.Ebrahim Abdallah- GM of CPAT-institute (career planning & training) 01004476667
Personal Profile
IT SKILLS
REFERENCES
SELF STUDY
GOALS
Page 5 of 7






Quality agreement and manufacturing / supply agreement for 12 product in Atos
-80% achieved in 6 monthes in all aspects of GMP to comply with Sanofi QMS (as a restart up)


1. Ensure timely completion of routine QA procedures, Manufacturing, Quality Control, and
packaging,in process testing checks, sampling, warehousing and other agreed upon duties.
2. Manages inspections of raw materials, materials in process, and finished products.
3. Ensure implementing GMP Regulation and ISO 9001, ISO 14001, 18001 AND ISO 17025
Standards
4. Follow up with production processes to ensure quality standard.
5. Plan & perform quality audits, investigate root cause and evaluate required corrective actions
6. Ensure all phases of Manufacturing, comply with relevant SOPs, GMP principles & safety
guidelines.
7. Planning & conducting preventive maintenance plans & Protocol for manufacturing process
& analytical methods in addition to cleaning methods validation
8. Auditing the analytical laboratory for compliance with GLP and other applicable regulations.
9. Preparing, evaluating & updating Corrective & Preventive actions program.
10. Preparing & supervising deviations & investigation reports
11. Implementing Change Control System
12. Supervise Writing, reviewing, and distribution of SOPs
13. Batch records review , finished product release. & MOH inspection visits management
14. Manages & develops validation policies, VMP and procedures
15. Oversees the required validation activities & Qualification of systems and equipment
(HVAC,Water station) & Calibration Master Plan
16. Manages VALIDATION OF SYSTEMS (equipment, utilities, facilities, product
manufacturing processes, cleaning procedures)


Areas of work according to EMEA regulations & Eudralex guideline:
1. Leading & executing Self inspection-Internal audit program.
2. Annual product review program.
3. CAPA system.
4. Managing & facilitating the MOH routine visits
5. Log-sheet / batch record review
6. Contribute to the resolution of GMP issues within the organization through identification
of problem areas and training of relevant personnel.
7. Trend analysis of viable environmental monitoring (Air & Water).
8. Trend analysis of non-viable environmental monitoring (Air & Water).
Job Activities At Eimc United
Sanofi - Atos project
Work Achievements & Activities
QA manager job description ATOS
PART B
Page 6 of 7

9. Monitoring daily activities & deviations (if any) on the previously mentioned areas.
10. Monitoring and follow up of deviations ,lab investigations ,OOSes ,alert notices
& change control system.
11. Conduct training (on/off job training) in several working areas to all employees
12. Supervising media fill process
13. Supervising Validation & routine qualification activities



1. Design and qualification of water treatment plant. Equipments used, layout, water flow,
DQ, IQ, OQ & PQ.
2. Design and qualification of production area, designing (rearranging) the layout, zoning ,! P ,
personal & material flow and room data sheet
3. Design warehouses (raw & finished) layout ,sections and work flow



1. Ensure timely completion of routine QA procedures, Manufacturing , Quality Control, and
packaging ,in process testing checks, sampling ,warehousing and other agreed upon duties.
2. Manages inspections of raw materials, materials in process, and finished products.
3. Ensure implementing GMP Regulation and ISO 9001 ,ISO 14001 and 18001 Standards
4. Follow up with production processes to ensure quality standard.
5. Plan & perform quality audits, investigate root cause and evaluate required corrective actions
6. Ensure that all phases of Manufacturing, comply with relevant SOPs, GMP principles and
safety guidelines.
7. Planning & conducting preventive maintenance plans & Protocol for manufacturing process &
analytical methods in addition to cleaning methods validation
8. Auditing the analytical laboratory for compliance with GMP and other applicable regulations.
9. Preparing & updating Corrective & Preventive actions program.
10. Implementing Change Control System
11. Supervise Writing, reviewing, and distribution of SOPs
12. Batch records review & finished product release.



1. Participated in building of the entire plant project as the QA head. Starting from DQ till having the
license in 7/2011.
2. Built the Documentation system ,ISO and GMP documents from A to Z .
- Quality policy, manual, procedures, relevant SOPs .
- Designed all the forms ,Labels and templates of:
Batch records.
(SOPs).
3. Created the Quality Manual , Established & Detailed the whole QMS of the company.
4. Participated in the project of preparing the Site Master File as a team member.
Start up of Atcopharma plant
QA Manager Job Description At Simco
Design & start up Experience At Simco:
! GMP and ISO relevant forms.
! Warehousing of raw materials

Page 7 of 7

5. Prepared two IPC labs one for the syrup and the other for solid department;
benches ,instruments and tools.
6. Supervised the execution of IQ ,OQ , commissioning & PQ of HVAC system
/relevant document review.
7. Supervised execution of IQ ,OQ&PQ of water station (3 phases) /relevant document review
8. Supervised the execution of IQ & OQ of capsule filling ,liquid preparation tanks
& filling ,labeling , sachet filling and dosering machines.
9. Designed and established documentation and management system of raw materials
warehouse starting from materials receiving passing by racks coding till housing & inventory
10. Working on process validation of dry mixing products (6 products)
11.Working on cleaning validation starting from Methods of Calculating Acceptance Criteria
passing by Bracketing And Worst Case Rating & Amount of residue determination ending with
cleaning Validation protocol
12.Executed thermal mapping for WH , cold store ,cool store & refrigirators
13. Batch records review & finished product release.
14.Control & maintenance of documentation system.
15. Recently responsible of the ISO 9001:2008 certificate project.


! Observe conditions on line and in-process area for compliance with the process method, for
correct operation of procedures and for cleanliness and clearance of other components.
! Responsible for Sampling of bulk and finished products to obtain representative samples.
! Perform checking tests at random throughout processes for critical start-up tests and to
check for correctness of printed materials.
! Review the executed manufacturing batch records for completeness, correctness, compliance
of in-process control results with specification and reporting of unusual incidents.
! Ensure production materials meet defined quality standards prior to disposition.
! Responsible for tracking and trending of out-of-specification results, failure investigation,
nonconformance, deviations, change controls and complaints.
! Monitors the environment of production and material disposition areas.

! Handled all activities of packaging area (syrups & semi-solids department that composed
of about 150 workers with 5 lines and a printing unit.
Created and implemented a Domestic HR system in the same area making new job
descriptions and specifications with performance appraisal and daily evaluation models
based on effective KPI's according to different roles and positions.
Implementing special techniques:
- Job rotation - Shadowing - Couching - On job training (specially GMP requirements)
Yielding a vast & remarkable improvement in ;Workers culture toward quality
GMP & system compliance Increasing in productivity by about 9%

Further info. ,Original Certificates, and Documents are available upon request
Job Description In Q.A Department At Sigma
Achievements In Production At Sigma