Curriculum Vitae

Professional Summary:
Deputy QC Manager with 13 years of experience in QC laboratories at finished
pharmaceutical products (FFP) and active pharmaceutical ingredients (API)
manufacturing companies, including Laboratory Quality Management System
(LQMS) gap analysis, implementation and auditing based on ISO/IEC 17025.

Personal Information:
Name: Akram Mohamed Abdelmoneim Ibrahim Elsabrouty
Date of birth: 20 August 1983
Address: 51 Elmohammadeya Street, Flat 26, Victoria, Postal code: 21411
Alexandria, Egypt
Mobile phone numbers: +201067301098
+17407301098
E-mail: el_sabrouty@hotmail.com
Nationality: Egyptian
Marital status: Married

Work Experience:
From August 2017 to present:
Title: Deputy QC Manager
Employer: Pharco B International for Chemicals (PBIC)
Location: Alexandria, Egypt
Description:
− Organizing and overseeing daily laboratory operations.
− Discussing routinely with QC manager the status of assigned tasks and potential problems.
− Reviewing laboratory records and ensuring adherence to data integrity principles.
− Reviewing electronic raw data, meta-data and system audit trail on Chromatographic Data
System (CDS).
− Writing, reviewing and updating standard operating procedures.
− Preparing and reviewing analytical method validation, verification and transfer protocols and
reports.
− Supporting in technical review of stability study, process validation and system validation
protocols and reports.
− Supervising QC section heads on work.
− Coaching new employees on the daily operation of laboratory activities.
− Evaluating the performance of QC personnel and providing them with feedback.
− Following up the qualification, verification, calibration, maintenance and cleaning for
laboratory Instruments.
− Monitoring consumable supplies, reagents, reference and working standards, laboratory
equipment and instruments to ensure the laboratory is well-stocked, and issuing purchase
requisitions when required.
− Monitoring laboratory environmental conditions and reporting any discrepancies.
− Auditing internal activities and conducting thorough inspections.
− Handling Out of Specification (OOS), Out of Trend (OOT) and Out of Expected (OOE)
investigations.
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 − Ensuring that the sample retention system is well implemented.
− Controlling changes in QC laboratory.
− Ensuring that Corrective and Preventive Actions (CAPAs) are implemented effectively.
− Taking part in customer and regulatory audits and inspections.
− Responsible for ensuring continual Current Good Manufacturing Practice (cGMP) and Current
Good Laboratory Practice (cGLP) compliance in the laboratory.
− Keeping eye on laboratory internal QA system.
− Monitoring and following-up adhesion to Environment, Health and Safety (EHS),
Occupational Health and Safety (OHS) standards as well as hygiene regulations during the
performance of laboratory activities.
− Communicating and coordinating with outsourced service providers.
− Contributing to preparation of Ravidasvir Active Pharmaceutical Ingredient Drug Master File
(API DMF).
− Reviewing compendial and guidelines updates to ensure ongoing compliance and to stay up to
date on current and proposed changes.
− Interfacing and reporting compliance concerns to the QC manager.
− Reporting any gaps or desired improvements in existing procedures to the QC manager to take
the desired corrective action.
− Escalating deviations to the QC manager and recommending solutions.
− Acting on behalf of the QC manager in case of his/her absence.

From April 2015 to July 2017:

Title: QC Compliance Section Head
Employer: Pharco B International for Chemicals (PBIC)
Location: Alexandria, Egypt
Description:
− Reviewing out-of-specifications results, customer complaints and customer rejected goods.
− Maintaining and calibrating some laboratory equipment according to work instructions, and
following up external calibration as scheduled.
− Performing testing for the qualification of reference standards.
− Ensuring the laboratory is well-stocked and resourced.
− Ensuring good housekeeping practices for clean, neat and tidy maintenance of laboratory.
− Providing technical advice to team members.
− Training and assisting new analytical chemists with daily operation of laboratory activities.
− Identifying staff requirements and communicating to QC manager and HR department to
initiate recruitment and training processes.
− Supporting in establishing and controlling of raw material’s supplier qualification program.
− Participating in the startup and licensing of “PBIC”; an API manufacturing site in Egypt,
including:
• Establishing and maintaining QC laboratory in full cGMP and EHS compliance.
• Participating in Validation activities including process validation for Sofosbuvir and
Ravidasvir, Analytical Method Validation and Water Treatment System Validation.
• Preparing Sofosbuvir (API DMF).
• Initiation of Oracle Enterprise Resource Planning (ERP) system module for QC activities.
• LQMS implementation.
• Preparation for the compliance of the quality control laboratory to international standards.

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From July 2012 to March 2015:
Title: QC Senior Analyst
Employer: Sigmatec for Pharmaceutical Industries
Location: 6th of October City, Giza, Egypt
Description:
− Working in raw material, in-process and finished product sections of β-Lactam QC laboratory.
− Sampling of raw materials, intermediates, finished products and water to obtain representative
samples, and preparing them for analysis.
− Performing routine physical and chemical analysis for samples with minimum supervision.
− Preparing and standardizing volumetric solutions, reagents, indicators and mobile phases.
− Compiling records and interpreting analytical results with adherence to Current Good
Documentation Practice (cGDP).
− Minor equipment calibration, troubleshooting and maintenance.
− Training new analysts on the daily operation of laboratory activities.
− Applying Laboratory Information Management System (LIMS) for managing samples and
their associated data.

From February 2009 to June 2012:

Title: QC Analyst
Employer: The Arab Company for Gelatin and Pharmaceutical Products (Arab-Caps)
Location: Alexandria, Egypt
Description:
− Working as QC Analyst in the color control, raw material, in-process and finished product
sections in QC laboratory, performing testing, methodology, validation and stability study
activities.
− Performing QC Analyst responsibilities with adherence to laboratory quality management
system.
− Assisting with QC data management and control charting.
− Generating, reviewing and maintaining technical records and documents.
− Using Material Requirements Planning (MRP) system for managing QC laboratory inventory.
− Participating in analytical method validation and cleaning validation associated tasks.
− Developing new accurate, simple, fast and economic methods of analysis to be used in routine
work of in-process analysis of pharmaceutical samples using chemometric techniques in UV-
Visible spectroscopy like derivative, absorption correction, Vierodt's and colorimetric methods.
− Associating as quality coordinator during the preparation for ISO/IEC 17025:2005
accreditation of QC laboratory, preparing and implementing documentation system and
insuring the accuracy of technical documents and logging system for auditing.

From June 2006 to September 2008:

Title: QC Analyst and QA Inspector
Employer: Pharco Pharmaceuticals
Location: Alexandria, Egypt

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 Description:
− Working as In-process Quality Assurance (IPQA) inspector, performing checking tests at
random throughout manufacturing processes, critical start-up tests and assuring the
correctness of printed materials and over-printed items.
− Sampling of intermediates and finished products to obtain representative samples and
preparing them for analysis.
− Performing physical and chemical analysis for In-process Quality Control (IPQC) samples.
− Preparing and standardizing volumetric solutions, reagents and indicators.
− Interpreting and recording data in accordance with Current Good Documentation Practice
(cGDP).
− Participating in gap analysis for IPQC laboratory during the preparation for ISO/IEC
17025:2005 accreditation.

Some Instrumental Practice:

High Performance Liquid Chromatography Tablet Friability Tester.
(HPLC) (UV/PDA). Tablet Hardness Tester.
Gas Chromatography (GC) Polarimeter.
(ALS/Head Space). Melting Point Apparatus.
IR Spectrophotometer (FTIR/NIR). Refractometer.
UV-Visible Spectrophotometer. Sieve Analysis.
Atomic Absorption Spectrometry (AAS). Particle Size Distribution.
Total Organic Carbon (TOC) Analyzer. Brookfield Viscometer.
Potentiometric Titrator. Capillary Viscometer.
Karl Fischer (KF) Titrator. Rotary Rheometer.
Moisture Analyzer. Texture Analyzer (Bloom).
Tablet Disintegration Tester. pH Meter.
Tablet Dissolution Tester. Conductivity Meter.

Education:
Degree: Bachelor of Science
Major: Chemistry/Biochemistry
Institute: Faculty of Science, Alexandria University, Egypt
Graduation date: May 2005
Grade: Good

Training and Certification:

3D Studio Max
The Faculty of Fine Arts, Alexandria University, Alexandria, Egypt
August 2003
Medical Analysis
Egyptian Syndicate of Scientific Professions, Alexandria, Egypt
January 2004
International Computer Driving License ICDL
The Arab Academy for Science and Technology and Maritime Transport, Alexandria, Egypt
April 2004
Computer Interfacing
Egyptian Syndicate of Scientific Professions, Alexandria, Egypt
July 2004

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Good Manufacturing Practice GMP
Pharco Pharmaceuticals, Alexandria, Egypt
February2007
Shimadzu Spectrophotometer
Heinrich’s Commercial Agency, Cairo, Egypt
July 2009
Shimadzu HPLC
Heinrich’s Commercial Agency, Cairo, Egypt
July 2009
English Language General
Syllabus Training Academy, Alexandria, Egypt
October 2011
Agilent HPLC
Agitech Technologies, Cairo, Egypt
August 2015
Agilent GC
Agitech Technologies, Cairo, Egypt
August 2015
Some Mettler Toledo Instruments
Labib Demian Youssef & Co., Cairo, Egypt
August 2015
ISO/IEC 17025:2005 Awareness and Implementation
EQM TQCSI, Cairo, Egypt
December 2015
Laboratory Quality Management System based on ISO/IEC 17025:2005
Quality Academy, Cairo, Egypt
February 2016
IRCA Laboratory Quality Management System Internal Auditor based on ISO/IEC 17025:2005
Quality Academy ESENEK, Cairo, Egypt
March 2016
Mastering CTD/eCTD Submission
Reyada Pro., Cairo, Egypt
October 2016
Handling of External & Regulatory Inspection
PBIC, Alexandria, Egypt
January 2017
HPLC Technique and Applications using UV, PDA and Fluorescence Detectors in
Pharmaceutical Industry
Alexandria University, Alexandria, Egypt
February 2017
Internal Quality Control
Alexandria University, Alexandria, Egypt
March 2017
ISO 9001:2015 & ISO 14001:2015 & OHSAS 18001:2007 Awareness
EgypticIso, Cairo, Egypt
March 2017

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Uncertainty Calculation
Alexandria University, Alexandria, Egypt
April 2017
ISO/IEC 17025:2005 Internal Audit
Alexandria University, Alexandria, Egypt
May 2017
Q-Metrics and Q-KPI of Pharmaceutical Industry
EgypticIso, Cairo, Egypt
May 2017
ISO Internal Auditor
EgypticIso, Cairo, Egypt
May 2017
Internal Auditor course for ISO/IEC 17025:2005
Egyptian Syndicate of Scientific Professions, Alexandria, Egypt
July 2017
Team Work
PBIC, Alexandria, Egypt
July 2017
Occupational Health and Safety Committee’s Members Program Advanced Training
PBIC, Alexandria, Egypt
October 2017
CTD, NeeS & eCTD Preparation & Submission
Egyptian Syndicate of Medical Toll Manufacturers, Cairo, Egypt
November 2017
Ravidasvir Manufacturing Process
PBIC, Alexandria, Egypt
April 2018
Ravidasvir Process Insights
PBIC, Alexandria, Egypt
May 2018
ISO 9001:2018 Standard Requirements
TMC for Consultations, Cairo, Egypt
May 2018
ISO 17025:2017 Standard Requirements & Uncertainty in Measurement
TMC for Consultations, Cairo, Egypt
July 2018
Web Design
Creative Group, Alexandria, Egypt
August 2018
Web Development
Creative Group, Alexandria, Egypt
October 2018
Spread Sheet Validation
PBIC, Alexandria, Egypt
February 2019

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 ISO 45001:2018 Standard
Team Quality Consultancy, Alexandria, Egypt
February 2019
Full Stack Web Development Diploma
Route IT Training Center, Alexandria, Egypt
March 2019
Computer System Validation (Part 1)
PBIC, Alexandria, Egypt
March 2019
Computer System Validation (Part 2)
PBIC, Alexandria, Egypt
April 2019
Ravidasvir Development Process & Impurity Control Strategy
PBIC, Alexandria, Egypt
April 2019
IT Policy
PBIC, Alexandria, Egypt
May 2019
Certificate of Appreciation for Stunning Performance
PBIC, Alexandria, Egypt
May 2019
Equipment Qualification
Charisma Quality Solutions, Alexandria, Egypt
October 2019

Languages:
Arabic: Fluent (native language)
English: Very good
French: Fair

Skills and Proficiencies:

Good knowledge of cGMP and cGLP.
Familiar with pharmaceutical regulatory compliance requirements as per EMA US FDA and
WHO.
Familiar with pharmaceutical guidelines and pharmacopoeias such as Ph. Eur., BP and USP.
Good understanding of ISO/IEC 17025:2017 Laboratory Quality Management System.
Thorough understanding of the key elements involved in assuring data integrity in a QC
environment, including performing data integrity risk assessment.
Good background in LIMS and CDS.
Comfortable utilizing advanced instrumental techniques for analysis with high ability to learn
new sophisticated instruments and to be familiar with their operating software.
Good scientific researcher.
Very good computer and IT skills including hardware, software, networking, internet and
troubleshooting.
Attention to detail.
Able to work independently and as a part of a team.
Able to organize and prioritize work so that multiple activities run concurrently.
Some practice in electronics.
Some practice in computer graphics.
Some practice in web design.
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