Quality Assurance Project Business Management
Post a job
|Saleh Mustafa Galeb
*** ********** ****** ( HARLEYSVILLE, PENNSYLVANIA ( 267.***.**** (
QA Technical Lead
Software Quality Assurance, Testing, & Analysis
Talented and motivated professional with proven record of success leading
and executing software quality assurance, analysis, testing, and validation
within deadline-driven, highly regulated environments.
~Career marked by highly visible roles with global leaders in the
> Well qualified with 20+ years of progressive experience spanning a full
range of IT operations, QA, systems analysis, programming, and
> Practiced in coordinating all phases of software testing lifecycle, from
requirements analysis through test planning, defect tracking, script/test
case development and test reporting.
> Reputation for designing and engineering QA and testing processes to
maximize efficiency while driving successful development and launch of
high performance, revenue-generating software products and solutions.
> Organized, take-charge professional with exceptional follow-through
ability and detail orientation; able to plan and oversee complex projects
from conception to successful conclusions.
( QA Project Management ( Software Testing &
Validation ( Test Planning & Reporting ( SOP Administration (
Test & Use Case Development ( SDLC Methodologies
( FDA GxP Regulations ( User & Functional Requirements (
( Vendor & Cient Relations ( Business Intelligence
( User Acceptance Testing
( Audit Remediation & Support ( (UAT) Unit & Regression
Testing ( IQ/PQ/OQ Protocols
( CFR Part 11 ( Design Specifications (SDS/SCS) (
Accenture ( Philadelphia, Pennsylvania ( 2012
Provides clinical trial data management solutions for pharmaceutical
QA LEAD / QUALITY ASSURANCE ANALYST
Recruited for Merck Merck AMS - SV&T QA engagement to direct QA and
Validation projects for multibillion-dollar pharmaceutical clients.
Analyzed and defined client business requirements, coordinating with
managers, business analysts, and users. Develop project plans; created and
managed Scope, Schedule, and Roadmaps; and defined/implemented resource,
communication, and risk management plans. Delivered progress reports to
stakeholders; resolved delivery and quality issues. Implemented
comprehensive validation, testing, and quality strategies to ensure maximum
system efficiency, conformity to engineering requirements, and accurate
release schedule for each system/client.
> Presided over high profile project for Merck's AMS -SV &T QA with focus
on QA audit preparation with review of audit questionnaire, Comparing the
Deliverable Matrix with the Operating Manual to make sure these are in
sink . Verifying the test factory training Deck as per business
requirement and updated the Operatin Manual accordingly.Major updating
the Operating Manual into new format as per business requirements.The
operating Manual has been splitted into four different documents as Test
Planning,Test Execution, Test preparation & Project Closeout.Business
inputs have been incorporated into the documents.Defined roles &
Responsibilities with Major activities including Extry/Exit
Criteria.Completed project on time.
> Led mission critical project to update Program based upon corporate,
user, and regulatory requirements. Review of requirements
to enable the test preparation process. Review of test cases prior to
execution. Post review of executed test cases and associated test
defects. Preparing various status reports to assist in test case
Setting up a Test Case Module in Quality Center to ensure that the
parameters are set up correctly.
K&L CONSULTING SERVICES INC. ( Fort Washington, Pennsylvania ( 2011
Provides clinical trial data management solutions for pharmaceutical
QA PROJECT LEAD / QUALITY ASSURANCE ANALYST / CONSULTANT
Recruited for short-term engagement to direct QA and Validation projects
for multibillion-dollar pharmaceutical clients. Analyzed and defined client
business requirements, coordinating with managers, business analysts, and
users. Develop project plans; created and managed Scope, Schedule, and
Roadmaps; and defined/implemented resource, communication, and risk
management plans. Delivered progress reports to stakeholders; resolved
delivery and quality issues. Implemented comprehensive validation, testing,
and quality strategies to ensure maximum system efficiency, conformity to
engineering requirements, and accurate release schedule for each
> Presided over high profile project for Merck's Research Labs (MRL) Bio-
Statistics Analysis & Research Division Science (BARDS) organization,
with focus on migrating and re-validating macros in SAS v9.1.3 legacy
environment to V9.3 in Unix environment. Completed project on time and
> Led mission critical project to update Johnson & Johnson's Dental eCRF
Program based upon corporate, user, and regulatory requirements.
Successfully updated validation plan, FRS document, and test scripts for
Dental eCRF system. Created traceability matrix, validation summary
report, and System Design Specification (SDS)/System Configuration
Specification (SCS) document.
MERCK & CO INC. ( Blue Bell, Pennsylvania ( 1998-2011
QA PROJECT LEAD / SR. QA TESTER & ANALYST / SR. SYSTEMS ANALYST / SOP
Progressed through increasingly responsible positions to lead and support
quality assurance, analysis, and testing projects for numerous internal
software products and solutions. Impacted mission critical operations
across numerous departments, thousands of global users, and corporate
compliance with FDA regulations. Created, maintained, and executed system
requirements and associated test protocols.
Saleh Mustafa Galeb ( Page 2 ( email@example.com
MERCK & CO INC. CONTINUED:
Prepared comprehensive test plans and test case documents; coordinated
traceability, usability and performance testing across all phases of SDLC.
Identified and resolved deviations between requirements and each system
build, consistently minimizing risks and audit findings. Noted for
skillfully translating system requirements and designs into clear test
> Took lead role in numerous projects, overseeing project planning,
scheduling, tracking, and resource assignment.
> Designed and implemented comprehensive system of benchmarks, key
performance indicators (KPIs), and metrics to assess and monitor quality
and risk factors for each release/rollout; deployed Agile with Scrum and
> Teamed with vendors, developers, and Project Managers to continuously
evaluate performance, identify/implement testing solutions, and detect
critical defects during early development processes.
> Developed and ensured compliance with test plan methodologies as well as
quality and performance standards to facilitate the delivery of value-
> Credited with streamlining and accelerating testing processes for
clinical trial software by implementing measures and procedures to
improve accuracy and thoroughness of document review processes. Trained
all testers and developers in the new procedures.
o Triggered 5% increase in productivity, 10% cost reduction and 98%
customer satisfaction rating.
> Selected intro role of Technical Lead for multiple projects and functions
including Book of Business support of Inform database refresh and nightly
generation of Cognos AE reports; verification of Patient Data Acusition
Management (PDAM) Merckury cases; and, initial set up of Match Merge
(MM), load define, verification of Standard Data Tabulation Model (SDTM
)mapping, CDR issues in UAT/Prod environment.
> Coordinated test engineering processes in CTS Clinical Trial Protocol
Collector environment. Oversaw analysis, design, development, execution,
summary and documentation of test sets in clinical trial software
developed using 3rd party tool based on Small Talk language.
> Consistently achieved implementation deliverables, effectively
negotiating through technical challenges and disparate priorities of
large and diverse stakeholder communities.
> Served as SOP Administrator for MRL IT from 2010-2011, analyzing,
standardizing, and benchmarking process and checklist for use by SOP
authors, reviewers, and appovers.
CAREER NOTE: Additional career history includes roles as Sr. QA Software
Tester for Info Technologies Inc., Sr. QA Tester for Standard Life
Assurance Company, Canada, and Programmer Analyst for Prudential Assurance
Company Ltd., Canada.
Education & Credentials
Bachelor of Computer Science
Certified Programmer Analyst
Herzing Institute, Montreal, Canada
Diploma in MS Access & MS Excel
Microcode Information Center, Montreal, Canada
Master of Science / Bachelor of Science
University of Dhaka, Dhaka, Bangladesh
Similar ResumesClinical SAS Programmer
United States - sas, programmer, clinical, sql, sap, oracle,...SAS Programmer clinical
Livonia, MI - sas, programmer, clinical, clinical research, sql,...SAS Clinical Programmer with 5 years of experience...
Princeton, NJ - sas, programmer, fda, clinical, sap, common, pdf,...websphere message broker and websphere MQ
India, Bangalore, KA - india pvt ltd, india pvt, wtx, enginnering,...Systems Analyst/SAS programmer
Rockville, MD - sas, developer, programmer, samples, fda, bae,...Data Clinical Programmer Experience Management
Rockville, MD - sdtm, sas programmer, sas, moscow, programmer,...Project Data Medical Assistant Manager Experience
Baltimore, MD - doctoral, data manager, timing, examples, sas,...Manager Data Management Assistant New York Health
NY - anesthesiologist, sas programmer, statistician,...Experience Manager Clinical Data Management Assistant
NY - liu, epidemiologist, sas, laura, programmer,...Data Sas Clinical Sql Experience Management Analyst
Mt Prospect, IL - sas base, dos, rtf, sas, biostatistics, cro,...