1. ICULUM VITAE
EJAZ SHAHID
Dubai, UAE
shahidejaz@hotmail.com
Mob: 00971-50-2346787
EDUCATION
M. Pharmacy Punjab University, Lahore, Pakistan (Distinction) 1985
B. Pharmacy B Z University, Multan, Pakistan (Distinction) 1982
TECHNICAL SKILLS
Quality Assurance & Quality Control
 Qualified Person for Global Pharma in the Ministry of Health-UAE, responsible for all Product
releases. Safety & cGMP audits & preparations for external Audits by Regulatory Agencies
(Ministry of Health Annual Audits)
 Developed quality assessments of processes, review and approve SOPs, specifications, validation
protocols, trend analysis reports etc. Identify and anticipate cross-functional compliance risks,
and propose risk-managed solutions.
 Identify industry and regulatory trends, evaluate them for applicability internally and implement
improvements as appropriate. Demonstrated ability to influence and collaborate with clients and
managers, Experience developing compliance systems and quality standards
 Developing quality monitoring & audits; Coordinate QA / QC objectives; analyze statistical data
& product specs for cost saving purpose.
 Deployment of Sanofi Phenix systems at Global Pharma; Event & CAPA Management, Change
Control Management and Quality Third Party, to be in line with Sanofi standards and as part of
integration process. Major role in SAP implementation for the approval and reversal of finished
products modules.
 Develop and deliver GMP Training, Technical Support and Guidance to production, packaging,
warehouse and laboratory staff on site.
 Carrying out Root Cause Analysis using different techniques for the non-conformities found
during Audits, Deviations, Complaints etc.
 Carrying out Quality Risk Assessment as per Sanofi guidelines; Risk categorization based on
Impact, Probability and Detectability of risk and writing Reports.
 Carrying out failure investigations e.g. OOS, OOT results, Stability Test results etc.
 Handling quality related Complaints, carrying out Root Cause Analysis, proposing Corrective
Actions to mitigate recurrences.
 Verification of audit trails and data integrity as part of internal audit program.
 Ensure implementation and follow up of Process validation, Analytical Method Validation,
Cleaning Validation, Hold Time and Deblisterization Studies, Third party and In-house
calibration program, as per the annual approved schedules.
 Excellent People Management skills.
Analytical
 Experienced in set up of a quality control lab, the methodology and operation of various
analytical instruments like HPLC, GC, Auto analyzer, IR, UV/Vis Spectrophotometer, Atomic
absorption.
 Stability studies as per ICH guidelines
 Experienced in Method Development, Method Validation & Method transfers.
 Calibration of instruments
 Trainings-cGLP, Analyst qualification/certification program
 Analytical experience of almost all dosage forms

2. ICULUM VITAE
R&D / Technology Transfer
 Plan and coordinate activities relating to Pharma technology transfer from ‘R&D to Plant’ in
coordination with related departments
 Products handled include liquid, tablet, dry powders, antiseptics at development stage
 Solid background in cGMP’s (GMP, GLP,GDP, GWP etc)
 Scale-up and process optimization, DQ/IQ/OQ, and process validations.
Regulatory Affairs
 Understanding of ICH, SUPAC, UAE, SFDA & GCC guidelines
 Preparation of the Technical Dossiers & assist Regulatory filings in GCC and other markets.
Project Management
 Coordinate and manage pharmaceutical product and process development activities to meet
regulatory needs for all Pharmaceutical dosage forms. Manage multiple projects from concept
phase through development, manufacture and launch.
PROFESSIONAL EXPERIENCE
Sr. Manager - Quality Assurance
Global Pharma-A SANOFI COMPANY, Dubai Aug 2014 - Present
Responsibilities:
Reporting to Site Director of Global Pharma and Sanofi Regional Quality Director in France.
Reporting part has been elaborated, mainly focused on implementation of all the Sanofi Directives,
Standards, Procedure and other related documents at plant level. Updating the progress of different matrix
through monthly report, training of employees for new standards and managing of budget, together with
routine activities. Member of technology transfer of products from Zentiva site to Global Pharma.
Responsible for the Integration process with Sanofi to be in line with all other sites of the region.
Sr. Manager - Quality Assurance
Global Pharma Co LLC, Dubai June 08 - Jul 2014
Global Pharma, established in 1998, is Dubai's first pharmaceutical manufacturing facility, with
operations in GCC, Africa and Far East Asia. It is a subsidiary of Dubai Investments, which is one of the
largest investment companies in the region.
Reporting to Site Director, managing a team of approx 20 with 4 direct reports, overall responsibility of
managing QA activities in two production plants (Beta Lactam & Non-Beta Lactam) with about 35
different Solid & Liquid oral dose products.
Responsibilities:
Quality Assurance/Quality Control
Qualified Person for Global Pharma in the Ministry of Health-UAE
Overall responsible for all activities of the following departments
 Quality Assurance
 Quality Control & Microbiology labs
 Stability & Validation
 Audits ( External and Internal)

3. ICULUM VITAE
Plant Operations: Ensuring all Plant operations are in accordance to cGMP requirements. Provide proper
QA support to production plants. To assure that all the finished products manufactured / imported /
marketed by Global Pharma comply with the defined specifications.
R&D / Technology Transfer: Responsible for Technology transfer from partners in India & Jordan to
Global Pharma Manufacturing Plants in Dubai. Facilitated many products transfers including solid, liquid
& dry powders. Involved in key Technology Transfer contracts with Multi-National Pharmaceutical
companies.
Bioequivalence studies: Assist Technical Manager for monitoring BE studies at select CRO’s for
Generic Product development, review protocols, bio-analytical reports.
Manager – Quality Assurance
Continental Chemicals (Pvt) Ltd, Karachi Dec 06 – June 08
A newly established Pharmaceutical unit, meant for providing medicines in areas of Oral solids, Oral
liquids, Capsules and Sterile products. Certified Pharmacist for the company’s MOH license.
 Established QA and QC department and compliance systems.
 Responsible for overall activities of all the QA / QC departments and Regulatory affairs.
Manager - Quality Control
Global Pharma Co LLC, Dubai Aug 01 - Nov 06
Responsible for all initial set up like Validation of Purified water plant, air handling units (AHU’s),
Instruments / equipment installation and qualifications, Preparation and approval of SOP’s, Specifications
and methods etc, in close coordination with concerned Departments and Management. Involved in vendor
audits and active member for the external audits team. Responsible for all the internal and external audits
like MHRA, TGA, Saudi Arabia, Gulf countries, African countries and local UAE audits.
Section Head - Quality Control
SPIMACO, KSA May 99 - June 01
Responsible for the Quality Control departmental activities of the company producing more than 100
dosage forms of Oral Solids, Oral Liquids, Ointment & Cream, Penicillins, Aseptics & Antiseptics in
collaborations with various multinational pharmaceutical companies worldwide such as Schering Plough,
Sandoz, BMS, GSK, Abbott, Pfizer, Biochemie and Roche.
Main responsibilities include
 Timely scheduling and releases of the batches.
 Review for the analytical data of validation exercises.
 Preparation of the technical reportsfor future development of the products.
 Final review of batch documents and their approvals
Section Head - Quality Assurance
SPIMACO, KSA Nov 95 - April 99
 To ensure that all the production operations are in accordance with cGMP.
 To supervise verification and sampling of incoming materials (raw materials & packaging
components in accordance with approved sampling instructions
 To conduct process validations, equipment validations and cleaning validations together with
Production Departments.
 To conduct GMP trainings.
 Preparation of SOP’s / Validation Protocols, Review of batch documents and approval
 Member of the Internal Quality Audit Committee for ISO 9000 & 14001

4. ICULUM VITAE
Senior analyst - Quality Control
SPIMACO, KSA Dec 91 - Oct 95
 Analysis of raw materials, semi-finished and finished products for different dosage forms using
various sophisticated instruments such as, HPLC, GC, Atomic Absorption, UV, Vis and IR
Spectrophotometers, Flourimeter, Auto Analyzer II, Particle Size Analyzer, Auto TLC Sampler,
Densitometer, Karl Fischer, Auto- Titrator and Digital Viscometer.
 Calibration of instruments
 Stability studies
 Validation of test methods of new products
 Preparation of SOP’s
Senior analyst - Quality Control
Beecham Pakistan (Pvt.) Ltd, Pakistan Feb 85 - Nov 91
 Analysis of raw materials and finished products (Antibiotics, Non-antibiotics & Toiletries)
 Calibration and maintenance of instruments.
 Incharge of Inspection and Packaging Section.
 Stability of regular and new products.
COURSES TAKEN
 Training on Quality Systems, France
 Auditors training for API & Excipients, France
 Quality Risk Management, Jordan
 Phenix Event & CAPA Management on site by Sanofi
 SAP training on site by Sanofi
 Development Program For Managers, Problem Solving & Decision Making,
 Internal Quality Auditors (ISO 9000 & 14001) program, IQM Middle East
 Elanco Capsule Machinability, Pharmaceutical Analysis & Quality Control, at SPIMACO
 Pharmaceutical Quality Control, SPIMACO
 Safety Awareness, SPIMACO
 Current Lab Controls & Compliance, SPIMACO
REFERENCES Available on Request