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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.

to ensure quality care by performing the following duties. ESSENTIAL DUTIES AND RESPONSIBILITIES include the
to ensure quality care by performing the following duties. ESSENTIAL DUTIES AND RESPONSIBILITIES include the

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.

Quality Manual Responsible for supplier audit and control Participates in on – job training with other
CV Contact Information » 14 Timor Street, Qwesna, M onofia - Egypt Mohammad Gamal EL
CV
Contact Information »
14 Timor Street, Qwesna, M
onofia - Egypt
Mohammad Gamal EL De an Hassan
E-Mail: mjh2you@yaho
o.com
2009
Mobile Phone +201040284
11 EGYPT
industry-based pharmacis
Home Phone
+20482576
56
Personal Information:
Birth Date:
Gender:
Marital Status:
Religion:
Nationality:
Resident of:
Hobbies:
Military Service:
Jan, 10, 1983
Male
Single
Moslem
Egyptian
Egypt – Qwesna_ Mon ofia
Reading, Computer, F oot ball, Ping pong
Matroh Military Hospit al MMH till December 2005 (Finished)
Education:
FACULTY OF PHARMACY_CAIRO U NIVERSITY
Degree:
B.Sc.
in Pharmaceutical Science
May 2004
Appraisal:
"Good" 70%,
Last Year "Very Go od
ARAB ACADEMY FOR SCIENCE AND TECH NOLOGY AND MARITIME TRANSPORT AAST
Degree:
Master in Quality Management Fe bruary 2008 till Now

Skills:

Computer skills

WIN (9x, 2000, NT)-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 and Quality Co ntrol and in a manufacturing environment within the pha rmaceutical industry. Ability to work with sophisticated technology . Interest in continued learning Effective time management Accuracy and efficiency. Good communication skills, both oral and wr itten. Encourages team building Analytical/critical thinking and problem-solvi ng skills Ability to work independently, as well as wit h a team.

Training and Certificates:

as well as wit h a team. Training and Certificates: Kahera Company for Pharmaceutical and Chemi

Kahera Company for Pharmaceutical and Chemi cal Industry (Summer Training)

September - October 2002

Quality control (Stability studies) Production Management (Tablets_ Capsul es_ Syrups_ Suppositories_ Injection)

Alkan Pharma and Lilly Egypt

Evaluating Analytical Data. Calibrations, Standardizations, and Blank Co rrection.

RHEIN-MIINAPHARM Biogenetics

Fermentation Special aspects(HIRUDIN-INTE RFERON) Principles of filtration, sterilizing filter qualifi cation, main Biopharma applications, products and mate ials. Ion exchange chromatography & Electropho resis (Protein Purification).

CV Job Experience: 1. Sigma Pharmaceuticals Industries: August 2008-Until Now Job Title: Methodology Senior Analyst.
CV
Job Experience:
1.
Sigma Pharmaceuticals Industries:
August 2008-Until Now
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).