This document contains a CV for Mohamed Moustafa El-Khatieb, including his personal details, education history, work experience, skills, qualifications, and interests. He has over 10 years of experience in quality assurance and quality control roles in the pharmaceutical industry, specializing in validation, qualification, analytical methods, and ensuring compliance with regulations. He holds a Bachelor's degree in Pharmaceutical Sciences and several quality and validation related certifications.

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Group 101, Building 10, Al-Rehab
City, Cairo, Egypt
Home: 02 – 26925859
Mobile: 010 – 91929293
E-mail: melkhatteb@gmail.com
Mohamed Moustafa El-Khatieb
Personal Data:
• Date of Birth: 30th of July, 1984
• Nationality: Egyptian
• Military Status: Exempted
• Marital Status: Married
• Linkedin: www.linkedin.com/in/mohamed-el-khatieb-138a1048
Education:
• 2001 – 2006 Faculty of Pharmacy, Al-Azhar University, Bachelor Degree of Pharmaceutical
Sciences with grade (Excellent) with honor.
• 1989 – 2000 Tawakul Language Institute, Tanta, Al-Azhar Secondary certificate with a grade 95%.
Experience:
• December 2014 - Present, Validation and Qualification Specialist, Quality Assurance
Department, Apex Multi-Apex Pharmaceutical Industries.
• December 2013 - December 2014, Quality Assurance IPC Specialist, Apex Multi-Apex
Pharmaceutical Industries.
• September 2012 - November 2013, Quality Control Supervisor, Apex Multi-Apex Pharmaceutical
Industries.
• September 2009 - December 2012, Quality Control Chemical Analyst, Apex Multi-Apex
Pharmaceutical Industries.
• January 2007 - August 2009, Quality Control Chemical Analyst, SIGMA pharmaceutical
industries.

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• Has the experience in the following:
1. EMA accreditation preparation team member, responsible for all validation related activities and
provides a technical support for concerned departments.
2. Establishing, developing, communicating and sustaining validation strategy, master plan and
requalification schedules.
3. Establishing, updating, and maintaining validation and qualification programs through WHO,
ISPE, FDA, CFR part 211, ICH, EMA-Eudralex, GAMP5, BP, USP and PDA guidelines for the
following:
• Process Validation
• Cleaning Validation.
• Storage areas Qualification (including conducting thermal mapping studies)
• Heating, Ventilation and Air-Conditioning (HVAC) Qualification.
• Clean room Qualification.
• Computerized Systems Validation (CSV)
• Building Management System (BMS) Qualification.
• SCADA System Qualification.
• Pharmaceutical Water Treatment Qualification.
• Compressed Gas Qualification.
• Production Equipment Qualification.
• Laboratory Instruments Qualification.
• Analytical Method Validation.
4. Work with Operations and other QA members to perform risk assessment plans for all products
processing and cleaning activities.
5. Implementation of guidelines of “Time and temperature sensitive pharmaceutical products
(TTSPP)”.
6. Investigation of Deviations and CAPA team member.
7. Performing a Supplier Evaluation and External Auditing for the suppliers.
8. ISO 9001 and ISO 17025 internal audit team member.
9. Implementation and following up the applying of cGMP guidelines in all quality related
departments in the factory.
10. Following up manufacturing processes of solid dosage forms including Tablets and Capsules.
11. Following up manufacturing processes of liquid and semi-solid dosage forms including Syrup,
Suspension, Shampoo, Cream and Suppository.
12. Following up dispensing process and activities in the dispensing room and ensuring its compliance
with cGMP guidelines.
13. Following up packaging processes in packaging area.
14. Manufacturing and Packaging Batch Review, Batch release and Annual Product Review.
15. Following up calibration of all balances and standard mass weights to be complying with the
cGMP guidelines, USP New chapter <41> and <1251>, OIML R111 and R76, Euramet and ISO/IEC
17025.
16. Establishing a validated computerized system for calculating results of both Raw material and
Finished product analysis using Microsoft Excel sheet and implementing a system for verification
of these calculation sheets according to Eudralex Annex 11 and OMCL quality guidelines.
17. Performing finished products, Bulk & Intermediate products analysis (Assay, Dissolution,
Uniformity of dosage forms, etc…) and all tests regards Finished Products.
18. Performing Raw materials analysis for compendial or non-compendial raw materials including
Impurities and related substances limit tests.

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19. Has a good Knowledge in analysis of Packaging Materials and its requirements according to USP,
FDA, EMA guidelines of Containers Closure Systems for Packaging Human Drugs.
20. Establishing and implementing a system for standardization and monitoring of working standards
that used in analysis of Raw materials and Finished products.
21. Responsible of receiving and control of Certified Reference Standards as well as impurities from
the United States Pharmacopeia (USP) or the European Pharmacopeia.
22. Responsible for archiving and control of non-compendial and compendial supplier testing
methods.
23. Establishing a control system for monitoring a performance of instruments using control chart
statistical tool by Microsoft Excel and Minitab.
24. Writing Standard operating procedures (SOPs) in the QC laboratory including General SOPs,
instruments SOPs and Raw material analysis SOPs.
25. EMA Project Coordinator in the QC laboratory, which is responsible -with the QC analysts- for
implementation EMA Eudralex guidelines in the QC laboratory.
26. Handling and using the following analytical instruments and techniques:
• HPLC (Agilent 1100,1200,1290 UPLC), Chemstation software and Openlab.
• HPLC (Shimadzu Prominence and Class-VP).
• FT-IR.
• NIR (Bruker and Perkin Elmer).
• UV spectrophotometry (Agilent, Shimadzu).
• Dissolution tester (Hanson and Agilent).
• GC (Shimadzu and Agilent)..
• Hardness and Diameter tester (Pharmatron).
• Friability tester (Pharmatron - Pharmatest).
• Disintegration tester (Pharmatron – Pharmatest).
• Particle Size Analyzer (Malvern).
• Atomic Spectroscopy (Agilent AA).
• TLC.
• Automatic potentiometer.
• Karl Fischer Titrator.
• Polarimeters and Refractometers.
• Vesicometer (Brookfield and Fungilab vesicostar).
• Suppository Hardness tester and melting point tester.
• pH meters and Conductometers.
• Able use most and learn all chemical and physical laboratory instruments.
27. Training of the new analysts and trainees.
28. Good knowledge of ISO Systems including ISO 9001, 14000, 17025, 18001.
29. Good Knowledge of Basics of Statistics, Statistical Tools and Lean Six Sigma.
30. Good knowledge of GMP, GLP, ICH, WHO, FDA, ISPE, Eudralex, PIC/s and CFR part 211 guidelines.
31. Good knowledge of Risk Assessment tools and Stages, especially FMEA (Failure Mode and Effects
Analysis).
32. Has a good talent in searching, reading, upgrading and being up to date.

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Courses & Certificates (Newest to Oldest)
1. Supply Chain Basics workshop, Career Advancers, January 2017.
2. ISO 901:2015 & ISO 14001:2015 and OHSAS 18001:2007, Risk Assessment Awareness Course, TÜV
Rheinland Egypt Ltd., November 2016.
3. Modern Pharmaceutical Process Validation, A Risk Science and Statistical Approach, proGamma
science corporation, July 2016.
4. Understanding the 2013 USP Revision of GC <41> and <1251>, Mettler Toledo Training Center
(LabTec), June 2016.
5. ASQ - Certified Six Sigma Black Belt (ASQ-CSSBB), Certificate No. 17869, March 2016.
6. eCTD, Towards successful SFDA/GCC submission, Ryada-Pro, Dr. Maged Fawzi, February 2016.
7. ISO-IEC 17025:2005 Internal Auditor Training, Multi-Apex, September 2015.
8. GAMP®5, Computer System Validation Work-Shop, Compliance-Control, February 2014.
9. Advanced HPLC Course, American British Institute, July 2009.
10. Series of courses in Quality Management, Arab Academy for Science, Technology and Maritime
Transport, Productivity and Quality Institute, 2008.
11. Course in using and operating Gas Chromatography, National Resource Center, January 2008.
12. On-job Training and Internal courses in the field of work including GMP, HPLC training,
Uncertainty, ISO 17025 Orientation Course.
13. English General Course (Upper-intermediate 1 level), British Council.
14. English Conversation Courses (till Level 6), Ministry of Defense Language Institution, 2006-2008.
15. Personal Selling Skills, Arab Academy Alex, Certified by American University in Cairo (AUC), July –
August 2006.
16. Negotiation Skills, Arab Academy Alex, Certified by American University in Cairo (AUC), July –
August 2006.
17. Clinical Practice for Pharmacists [Clinical Pharmacology], In Ministry of Health and Population
with co-operation of International Cultural Center (ICC), July – August, 2006.
18. Course of Preparing Freshly Graduates for Pharmaceutical Markets, Certified by Egyptian
Pharmacists Syndicate, August 2006.
19. Students Skill Development Program organized by Recruitment & Training Committee in Faculty
of Pharmacy – Cairo University, November 2006.
Languages:
• English: Very Good
Computer Skills:
• MS Word, MS PowerPoint, MS Excel, MS Visio, Minitab, Auto-CAD: Very Good
• Has the ability to deal with all computer programs and operating systems.
Activities during university period:
• Active member in Al-Azhar Pharmaceutical Students Association (APSA).
• Active member in Future's Pharmacists Family, Faculty of Pharmacy, Al-Azhar University.
• Member in Organizing Committee of Al-Azhar 4th
International Conference for Pharmaceutical
& Biological Sciences.
Personal Interests:
• Reading, Computer & Internet, Electronics and Travelling.
References:
• Are furnished upon request.