AKRAM ELSABROUTY

3938 Shawnas Way, Amelia OH · (740) 730-1098

el_sabrouty@hotmail.com

QC chemist 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.

EXPERIENCE
AUGUST 2017 – PRESENT
DEPUTY QC MANAGER, PHARCO B INTERNATIONAL FOR CHEMICALS (PBIC)
ALEXANDRIA, EGYPT
− 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 audit trails 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.
− 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.

APRIL 2015 – JULY 2017

QC COMPLIANCE SECTION HEAD, PHARCO B INTERNATIONAL FOR CHEMICALS
(PBIC), ALEXANDRIA, EGYPT
− 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 laboratories.
− 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 laboratories 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 laboratories to international
standards (WHO and FDA).

JULY 2012 – MARCH 2015

QC SENIOR ANALYST, SIGMATEC FOR PHARMACEUTICAL INDUSTRIES, 6TH OF
OCTOBER CITY, GIZA, EGYPT
− Working in raw material, in-process and finished product sections of β-Lactam QC
laboratories.
− 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.

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 FEBRUARY 2009 – JUNE 2012
QC ANALYST, THE ARAB COMPANY FOR GELATIN AND PHARMACEUTICAL
PRODUCTS (ARAB-CAPS)
− Working as QC Analyst in the color control, raw material, in-process and finished product
sections in QC laboratories, 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 laboratories
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 laboratories, preparing and implementing documentation system and
insuring the accuracy of technical documents and logging system for auditing.

JUNE 2006 – SEPTEMBER 2008

QC ANALYST AND QA INSPECTOR, PHARCO PHARMACEUTICALS
− 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.

EDUCATION
MAY 2005
BACHELOR OF SCIENCE (CHEMISTRY/BIOCHEMISTRY), FACULTY OF SCIENCE,
ALEXANDRIA UNIVERSITY, EGYPT
Grade: Good.

LANGUAGES
• Arabic: Fluent (native language)
• English: Very good
• French: Fair
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SOME INSTRUMENTAL PRACTICE
• High Performance Liquid Chromatography • Tablet Hardness Tester.
(HPLC) (UV/PDA). • Polarimeter.
• Gas Chromatography (GC) (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.
• Tablet Friability Tester.

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
• 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
• 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
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• 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
• 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

SKILLS
• 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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