CV

Dr. Mohamed Gamal El Dean Hassan

Objective: Quality Assurance Officer With the
following job description.

SUMMARY: Interprets and implements quality assurance

standards to ensure quality care by performing the
following duties.

ESSENTIAL DUTIES AND RESPONSIBILITIES include

the following. Other duties may be assigned.

Reviews quality assurance standards, studies

existing policies, and procedures

Writes quality assurance policies and procedures.

Ensures the strict implementation of the
international requirements such as GMP, EU, FDA,
TQM, HACCP, & ISO

Selects specific topics for review such as problem
procedures, drugs, high volume cases, high risk
cases, or other factors.

Compiles statistical data and prepares narrative
reports summarizing quality assurance findings.

Prepares validation protocols in cooperation with
the responsible
person for all types of validations

Prepares all validation and qualification
documents

Audits the SOPs System

Reviews and approves on the site master file,
company quality policy and Quality Manual

Responsible for supplier audit and control

Participates in on – job training with other
departments.
 CV
Contact Information »
14 Timor Street, Qwesna, Monofia - Egypt
Mohammad Gamal EL Dean Hassan E-Mail: mjh2you@yahoo.com
Mobile Phone +20104028411
0104028411 EGYPT 2009
industry-based pharmacis Home Phone +20482576956
482576956
Personal Information:
Birth Date: Jan, 10, 1983
Gender: Male
Marital Status: Single
Religion: Moslem
Nationality: Egyptian
Resident of: Egypt – Qwesna_ Monofia
Hobbies: Reading, Computer, Foot ball, Ping pong
Military Service: Matroh Military Hospital MMH till December 2005 (Finished)

Education:

FACULTY OF PHARMACY_CAIRO UNIVERSITY

Degree: B.Sc. in Pharmaceutical Science May 2004
Appraisal: "Good" 70%,, Last Year "Very Good

ARAB ACADEMY FOR SCIENCE AND TECHNOLOGY AND MARITIME TRANSPORT AAST
Degree: Master in Quality Management February 2008 till Now

Skills:
Computer skills
WIN (9x, 2000, NT)-Microsoft
Microsoft Applications &Microsoft Office software & the Internet
First level of maintenance (computer)
Linux Operating System
Graphics (Photo Shop-Maya–AutoCAD)
Languages
Arabic Mother Tongue
English Very good
French Beginner
Commitment to Quality:
Able to implement all cGMP, GLP Rules.
Knowledge of FDA and ICH guidance.
Familiar with HACCP rules.
Familiar with ISO 9001-2000.
Basic Six Sigma awareness.
Work skills
3 years in Quality Assurance
surance and Quality Control and in a manufacturing environment within the pharmaceutical industry.
Ability to work with sophisticated technology.
Interest in continued learning
Effective time management
Accuracy and efficiency.
Good communication skills, both oral and written.
Encourages team building
Analytical/critical thinking and problem-solving
solving skills
Ability to work independently, as well as with a team.

Training and Certificates:

Kahera Company for Pharmaceutical and Chemical Industry (Summer Training) September - October 2002
Quality control (Stability studies)
Production Management (Tablets_ Capsules_ Syrups_ Suppositories_ Injection)
Alkan Pharma and Lilly Egypt
Evaluating Analytical Data.
Calibrations, Standardizations, and Blank Correction
Correction.
RHEIN-MIINAPHARM Biogenetics
Fermentation Special aspects(HIRUDIN-INTERFERON)
INTERFERON)
Principles of filtration, sterilizing filter qualification, main Biopharma applications, products and materials
materials.
Ion exchange chromatography & Electrophoresis (Protein Purification).

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 CV

Job Experience:
1. Sigma Pharmaceuticals Industries: 2009 Now
August 2008-Until
Job Title: Methodology Senior Analyst.
Methodology Senior Analyst: Industry: pharmaceuticals
Job Function: Research & Development.
Description:
1. Develop method to test new chemical entities and impurities/degradants in the finished products.
2. Validate and troubleshot the method for testing new chemical entities.
3. Develop and troubleshot the stability-indicating testing methods for drug products.
4. Analyze organic and inorganic compounds to determine chemical and physical properties.
5. Coordinate with Quality Control department to smoothly transfer the method to QC chemists.
6. Prepare the Quality Control Protocol and Stability-Indicating testing Summary.
Qualifications:
1. HPLC and GC method development and validation.
2. Expertise working with laboratory instrumentation including: HPLC, GC, LC/MS/MS, Dissolution, UV-Vis, etc.
3. Experience in an FDA regulated environment as well as familiarity with issues of compliance with Ministry of Health
regulations.
4. Experience in an analytical laboratory
2. RHEIN-MIINAPHARM Biogenetics September 2007- August 2008
Job Title: Specialist, Manufacturing
Fermentation Area Specialist: Industry: Biopharmaceuticals/Biotechnology
Job Function: Operations/Manufacturing
Description: Area Classification: Class A ,B ,C
1. Assuring that the manufacturing equipment and processes are
meeting safety and quality standards while supporting implementation of various changes and improvements.
2. Works closely with other departments, including Manufacturing Technology, Validation and Facility Operations, QC and
QA. Under own initiative and using independent judgment, performs a variety of functions that directly support the
manufacturing of biopharmaceuticals by: Following standard Operating procedures and Good Manufacturing Practices,
provides high-level technical support and consultation for the fermentation, recovery, and purification processes.
3. Trouble shoots and resolves highly complex equipment problems and takes corrective action.
4. Writes operating procedures to incorporate new or changing equipment, products and processes.
5. Ensures implementation of new processes to maintain production.
6. Works with scientists to report results of experiments and analyzes data to assist in technology transfer.
7. Participates on project teams and performs special projects as needed.
8. Makes recommendations based on previous experience.
9. Completes all required documentation for proper traceability purposes.
10. Maintains accurate production records to comply with regulatory requirements.
11. Trains associates on operation of new equipment to ensure proper use.
Qualifications:
1. Understand, read, and write technical information.
2. Experience with equipment such as stainless steel tanks, bioreactors, centrifuges, filtration systems, chromatography
systems, control systems (DCS, PLC, SCADA, etc.) and CIP/SIP systems.
3. Experience with microbial fermentation, protein refolding, and protein purification.
4. Adhere to Department Safety Guidelines. Department specific requirements: (includes reporting relationship,
specialized experience & skills, work hours, work location, core competencies).

3. Lacto Misr For Baby Milk & Foods September 2006 –September 2007
Quality control Analyst.
Job Title: Junior Analyst,
1. Responsible for chemical Analysis of raw materials and finished product. Industry: pharmaceuticals
2. Responsible for performing method validation for new analytical methods. Job Function: Quality Control Chemical Lab.
3. Water Full Analysis for the RO station.
4. Performing instrumental analysis using HPLC, IR, NIR and UV.
4. Kahera Company for Pharmaceutical and Chemical Industry April 2006- September 2006
Quality Assurance Officer. (In process Control) (Tablets_ Capsules_ Syrups_ Suppositories _Injection)

5. Matroh Military Hospital MMH (Leader of medical supplies) Jan 2005-Jan 2006 (One year)
1. Hospital Pharmacist (External &Internal Pharmacy and Stores).
2. Clinical Pharmacist (ER-ICU-Surgery Room).

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