Mohamed Ibrahim Elkomy is an Egyptian national working as an Analytical Development Supervisor and Packaging Development Supervisor in Saudi Arabia. He has over 10 years of experience in the pharmaceutical industry, specializing in analytical method development, validation, and stability testing. He is responsible for supervising analytical laboratories, developing and validating methods, executing stability studies, and ensuring compliance with cGMP guidelines. He also leads packaging development activities including material specification preparation and validation.

1. Mohamed Ibrahim Elkomy
Date of Birth 1 Sept. -1983
Nationality Egyptian
Gender Male
Marital Status Married
Military Status Exempted
Address Saudi Arabia , AlQassim
Email Address M.elkomy@deef.com
Mobile Phone 0542546374 , 0542564581
O B J E C T I V E S
Want to improve and develop my experience in the field that I like beside my studies, in a way that
utilizes my ambitious personality toward achieving some high challenges in that field, in order to become
expert to being able to reach the most ambitious executive levels.
Total Experience years in pharmaceutical field about 10 years
Current job Analytical development supervisor (Methodology &validation and
stability) from April 2013 till now in DEEF Pharmaceutical Industries in KSA
 Creating analytical methods for analysis for new products including (Assay, Related substances,
Dissolution….etc.) (qualitative and quantitative method)
 Validate the new methods according to ICH guideline
 Developed the old analytical method for decrease the time for analysis and enhancing system
suitability and separations then validate it according to ICH guideline
 Execute and planning for stability samples for scale up batches according to GCC guidelines for
stability.
 Compilation for stability data and doing trend analysis for the results
 Prepare Stability summary ,stability approval and commitment letter required for eCTD
 Sharing in Investigation for OOS for finished product and stability samples.
 Prepare, revise and establish GTP, SOPs and STPs regarding to quality section.
 Leading the analytical method transfer between external laboratory and Quality control laboratory.
 Execute and supervise calibration and verification for these instruments potency analysis (HPLC,
GC, UV,) and physicochemical analysis AA, IR, PH, Viscometer, Conductivity Meter, Polarimeter,
Karl Fischer Apparatus, Dissolution Tester, Disintegration, Friability apparatus and Hardness
Tester, TOC, Melting Point Tester
 Review process validation protocols and report and ensure all developing projects, initiatives, and
processes are in conformance with local and international guidelines.
 Supervises the investigation of results and minimizes laboratory errors.
 Support the product registration/dossier compilation activities.
 Finding solution for troubleshooting in analytical laboratory including instruments
troubleshooting and the methods problems
 Prepare analytical quality part in module 3 and in module 2 in eCTD and upload to Docubridge
system also answering 1.9 Responses to questions from SFDA and GCC Countries.

2.  Updating, creating and trains for the report and results by custom field in empower software.
 Prepare protocols for stability studies and analytical method validation, cleaning and process
validation.
 Follow up the instrument routine maintenance by its agent and create the needful from new
instruments that we need.
 Reviews validation of test methods are validated by QC members after receiving from R&D.
 Conducts all administrative duties including regulation of work hours, work shifts, overtime, etc.
 Ensures that qualified, skilled, and trained personnel and other resources are available
 Provides technical expertise in support of the development of Q.C. testing methods & material
specifications.
 Review TDP for technology transfer from external laboratory.
 Provides feedback and evaluations as needed and required
 Monitors training plan and matrix as required ensuring compliance and staff proficiency.
 Assists management of critical laboratory programs such as internal quality control program,
measurement of uncertainty.
 Directs, through intermediate personnel, workers engaged in inspection and testing activities to
ensure continuous control over materials and products
 Reviews and evaluates all data generated by different operations and quality control department
and accordingly release or reject the raw & packaging materials
 Plans, coordinates, and directs quality control program, designed to ensure continuous production
of products consistent with established standards.
 Develops and analyzes statistical data and product specifications to determine present standards
and establish proposed quality and reliability expectancy of finished product.
From January 2014 added to me the responsibilities of Packaging development
 Preparation of packaging material specification, standard testing procedures of primary packaging
material as per BP/ USP/ Indian standard method and secondary packaging material as per in-
house method.
 Leading the track and trace project in Deef company and responsible about its implementation.
 Packaging development of new products, which involves feasibility studies, various tests for new
packaging materials to minimize risk and updating of packaging development in existing products.
 Preparing packaging bill of material records.
 Create the code system for all items in deef company (finished products& Raw materials&
Packaging materials& lab accessories& lab. chemicals and general items)
 Co-ordinate with different department like Documentation, Quality control, QA, Purchase,
Production and designer department etc. for developing the artwork and constant supply of
packaging component as per the requirement of marketing department.
 Working for cost reduction project of packaging material.
 Work with R&D to identify/develop packaging components for new pharmaceutical products.
 Responsible for providing expert technical support for the development, procurement and
troubleshooting of Packaging materials and components to support Site Packaging operations.
 Prepare container closure systems report in module 3 and in module 2 in eCTD and upload to
Docubridge system
 Ensures that Packaging-related Documentation (component specifications, BOM, and Packaging
Instructions) is maintained within compliance specifications. Preparation of artworks and
approval for the same
 Extensive experience with blister packaging components and process

3. Formulation development and registration experience
 Preparing and justification for specification of finished goods (FS, IS, SS) and upload to
Docubridge system.
 Preparing and execute comparative study between brand and generic product, Perform
incompatibility study for R&D product.
 Trained on DocuBridge software and can work on it
 Prepare technical files required for eCTD submission and upload to DocuBridge.
 Response to the inquiries received from authority and reviews the answer of all related parts.
 prepare related profile for the generic products and brand products and responsible about stress
testing study.
Quality control Supervisor (Finished product and stability) from October 2010 – April 2013
 Supervise the lab work in stability and finish product sections
 Create protocols and reports for analytical method validation
 Perform cleaning validation, protocol and reports and non-routine validation
 Perform verification for empower software, calibration for glassware, calibration for all HPLC
 Create plan for stability analysis every month, Follow up the analysis and reviewing analysis and all
log books register by the stuff.
 Responsible about stability study for second part (Actavis product)
 Create, review, and revise Standard Operating Procedures (SOPs), Quality Control Deviation
 Reports (QCDRs), controlled forms, and worksheets for the QC laboratory.
 Perform comparison evaluation of in-house methods and current USP monographs and submit
equivalency report once testing has been completed.
 Supervise in the operation and qualification of the new laboratory equipment.
 Perform initial phase training for new employees of the QC lab, Initial training for new SOPs and
revised SOPs.
 Standardize in house working standards, Keep reference and working standards.
 Manage the Quality Control instrument calibration program, as well as the hardware and
software associated with the instruments.
 Assesses the performance of QC Staff, recommends further training and practice to enhance their
competency.
Quality Control Senior ( Finished and stability) from May 2008 – October 2010
 Perform complete analysis for IPC samples, finished product samples and stability samples.
 Monitor stability samples at the predefined conditions and withdrawal it according to plan.
 Create computerized form for record of analysis and report of analysis for finished product and
certificate of analysis.
 Implement all types of stability studies (Accelerated, intermediate, long term and after
reconstitution)
 Create Standard test procedures (STPS) for finished Product and validate it.
Finish product Specialist from January 2006 – May 2008 (Delta pharma in
Egypt)
 Perform routine analysis of IPC and finished products samples and cleaning validation samples
Analyze process validation samples.
 Follow and preparing reagent solutions and other analytical requirements.

4.  Analyze cleaning and process validation samples.
 Perform physical & chemical analysis using wet chemistry methods and instrumentations including
HPLC, GC,AA,IR etc
 Implement environmental, health and safety (EHS) in the laboratory.
E D U C A T I O N
 Zagazig University-Faculty of Science.
 Specialization: Special Chemistry.
 Grade: Good (74.99%)
I T S K I L L S
 Computer skills: Microsoft word, Excel, SAP and Internet application
International Computer Driving license (ICDL). From UCO at 23-08-2008
L A N G U A G E
 Arabic: Mother tongue
 English: V. Good
P E R S O N A L S K I L L S
 Hard worker and able to learn new tasks quickly.
 Ability to work independently or in a team.
 Good planning skills.
 Achieving work in time.
 Good communication and presentation skills.
 Able to work under pressure, Attention to details, Team player with ability to work cooperatively
and productively with stuff inside and outside of the department.
 KSA experience
T R A I N I N G & C E R T I F I C A T E S
 Training on software for eCTD compilation (Lorenz DocuBridge).
 Training on "Testo saveris" system for Environmental monitoring system. 09-2012
 Training on Agilent 7890 GC hardware and chemstation. 06-2012
 Training on atomic absorption spectrophotometer (Shimadzu AA7000) 10-2011
 Training by WATERS on HPLC Empower 3 software and customer field 09-2011
 Tablet & Capsule manufacturing QC/QA challenges workshop. (Riyadh, 16th -18th Jan 2011).
 Training on HPLC conducted by WATERS.
 Training on AA conducted by Shimadzu.
 HPLC (fundamental, method development and validation) sponsored by Pharmex group.
 Training on Dubai on UPLC and HPLC fundamental basis and empower software
R E F E R E N C E S
 To be furnished upon request.