Software Quality Assurance - Information Technology Resume Search
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Software Quality Assurance Resume

Desired Industry: Information Technology SpiderID: 71877
Desired Job Location: Holland, Michigan Date Posted: 3/17/2014
Type of Position: Full-Time Permanent Availability Date:
Desired Wage:
U.S. Work Authorization: Yes
Job Level: Experienced with over 2 years experience Willing to Travel: Yes, 25-50%
Highest Degree Attained: Masters Willing to Relocate: Yes

Progressively develop a career in QA
field and implement testing process &
quality standards for manual and
automation testing.



Organization: SIRO Clinpharm Pvt. Ltd.
Designation: Data Management Project
Manager and Sr. Executive-Clinical
Database Developer and Editcheck
Programer for Validation
Period: Nov2010 – July2012.

Key Responsibilities :
• Complete overseeing of Startup,
Conduct and Closeout activities of given
• Ensure internal departmental SOP
and GCP/ICH compliance and optimize
general operation of the department
• Authoring and review of study
related document DMP, DVP and DE
• Accountable for ensuring project
deliverables met within study timelines
• Assisted in developing
departmental SOPs and training new hires
in these documents.
• Provide weekly and monthly
project progress metrics to the client.
• Successfully and individually
handled data migration and data
validation from clients database to
inhouse database.
• Build study database, testing
database, write edit checks and test

Organization: SIRO Clinpharm Pvt. Ltd.
Designation: Team Lead (SIRO-Pfizer
Period: Sep 2008 – Dec 2008

Key Responsibilities:

• Lead a team of 6 dedicated
resources in data management activities
using Oracle Clinical 4.5.1
• Responsible for the quality of
all deliverables submitted by the team.
• Introduce processes and improve
existing processes to ensure high
quality outputs.
• Training and mentoring team and
resolving queries from the team and
• Deriving study related metrics
thereby tracking efficiency of
• Optimize Resource Utilization
and be responsible for team’s
• Hands on data management
activities as lead data manger (LDM)

Organization: SIRO Clinpharm Pvt. Ltd.
Designation: Training Coordinator & Data
Reviewer and Validation
Period: July 2008 to Sep 2008
Key Responsibilities:
• Develop edit checks and data
review of assigned studies.
• Ensure that all study start up
activities are conducted in compliance
with relevant regulatory requirements
using agreed standards.
• Drive and improve processes to
minimize error rates.
• Implement and promote the use of
consistent, efficient and quality
processes to meet timelines and
deliverables for the site based project
teams, be accountable for the quality
and timelines of deliverables.
• Identifying training needs
within the group, and developing
training modules.
• Ensuring up-to-date
documentation of training records.
• Providing training or
orientation to the new resources.
• Perform random mock audit
preparedness check on the team.
• Be compliant with all client
procedures & SOPs.
• Timely escalation of all issues
to the supervisor.
• To take on additional
responsibilities proactively as and when

Organization: Pfizer Pharmaceuticals
India Pvt. Ltd.
Designation: Associate Study Start up
Period: Feb 2006 –July 2008
Key Responsibilities

• Develop database in Oracle
Clinical 4.5.1 as per the study/protocol
• Provide technical expertise in
the production and delivery of the study
start up services.
• Be accountable for the quality
and timelines of the deliverables.
• Ensure that all assigned
activities are conducted in compliance
with relevant regulatory requirements
using agreed standards.
• Participate where required, in
implementation of worldwide initiatives.
• Creation of Global Library
objects as per the request
• Provide support to Primary
contacts (PCs) for study start up issues
as required.
• Coding of medical terms using
Clinical TMS version 4.5.1

Organization: Pfizer Pharmaceuticals
India Pvt. Ltd.
Designation: Associate Biometrician
(Data Manager)
Period: March 2005 to Jan 2006

Key Responsibilities:
• Prepare study documentation like
validation procedure specifications,
Level-1 corrections documents, CRF
filling guidelines etc. for the assigned
• Test and execute validation
procedures and database
• Manage the error (auto generated
and manual) on the assigned studies in a
timely and efficient manner
• Generate queries to clarify and
improve the quality of the data
• Update data with query
resolutions received from the
investigators and closing out the
• Provide feedback on the database
designed for the study by carrying out
the database testing and reporting tool.
• Review of annotated Case Report
• Manual Review of the listings
pulled from Integrated Review and also
quality control of the data as seen on
the CRF and the database
• Liaise with external vendors and
work in coordination as a team to meet
the timelines of the study.
• Perform the DB lock procedures
as per the SOP requirements
• Perform database audit as part
of Quality Control.
• Run break blind/TDES.
• Provide ad-hoc data listings as
and when needed.


• Master of Science in Life
Sciences specialization in
Biotechnology, 2004 with 65.30% (First
Class) from, Mumbai University, India.
• Bachelor of Science in Life
Sciences - 2002 with 73.00% (First
Class) from Ramnarain Ruia College,
Mumbai University, India.
• Certificate Course in Clinical
Data Management from Institute of
Clinical Research India (ICRI)
• Course in Quality assurance and
software testing.

• Excellent proficiency in Oracle
Clinical version 4.5.1 and Inform
• Proficiency in Integrated Review
version 9.1.1
• Excellent proficiency in MS
Word, Excel, Power point, internet and
other basic applications.

• Sound knowledge of Software
Development life Cycle (SDLC) and
Software Testing
• Life Cycle (STLC).
• Manual Testing in different
testing methodologies like Agile, Scrum,
Waterfall etc.
• Sound Knowledge of developing
and executing Test plan and Test Cases
for Functional and Regression testing.
• Clear Idea of Black box Testing,
White box testing, Unit Testing, User
acceptance Testing, Functional,
Integration, Regression, Performance,
Security, and Stress Testing.
• Participated in requirement
reviews, analyzing requirements,
developing test plan and test cases,
Requirement Traceability Matrix, Defect
management, Reporting and tracking.
• Proficiency in Structured Query
Language (SQL), Joins, PL/SQL stored
procedures & Triggers.
• Currently pursuing Automated
Testing course at H2K Infosys.

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