1. Arun Sivakumar
Arun Sivakumar
Mobile: +91 8220133233
Email: arun.sivakumar@outlook.com
_______________________________________________________________________________
Objective:
To work with an organization which provides Testing opportunity that utilizes my skills and
communications to influence organizational growth and bottom line profitability.
Experience Summary
• I have around 50 months of experience in Testing Services across System testing, Validation
testing, Functional Testing and Defect Management.
• Played the role of Team Lead and Team Member in various projects across the software test life
cycle including Requirement analysis, Test planning, Test execution and Defect management.
• Having experience in Computer System Validation.
• Involved in various Team Management activities like Status Reporting and Metrics Collection.
• Knowledge in Life Sciences Domain (21 CFR Part 11 & FDA) guidelines.
• Trained entry level trainees on testing practices.
• As part of projects in Life Sciences domain, has been involved in Requirement Analysis, Testing,
Project Management and Review activities related to GxP validation process.
• Involved in various Team Management Activities like Status Reporting & Metrics Collection,
facilitating project level audits.
Employment History
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2. Arun Sivakumar
Internal Certifications:
Cognizant Certified Professional in the following:
Life Sciences Testing (L-0)
Software Testing (L-0)
Life Science Domain (L-0)
Automation Testing (Learner)
Mobile Testing (Learner)
External Certifications:
ISTQB
Microsoft certified professional in ASP.net
Visa Details
None
Contact Details
Mobile No. +91 8220133233
Mail ID : arun.sivakumar@outlook.com
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Education and Certifications
Title of the Degree with
Branch
College/University Year of Passing
Bachelor of Engineering Maharaja Engineering College
Affiliated to Anna University,
Coimbatore.
2010
Technical Skills
Operating Systems Windows XP, Windows 7, windows 8
Testing Methodologies Validation Testing, Functional Testing, System Testing, Regression Testing,
Data migration verification.
Testing Tools Quality Center 10, Quality Center 11.
Certifications
3. Arun Sivakumar
Relevant Project Experience
Organization: Cognizant Technology Solutions
Project 1:
Title M – Files VM
Duration August 2014 to till date
Role Team Member (Offshore)
Testing Management Tool Lotus Notes
Project Description:
The ABBOTT M-Files application is to replace the QDMS application with Abbott M-Files for Document
Management (DM) and Validation Management (VM) system. M files have both Desktop and Web based
applications. The application is accessible to all Abbott employees and all contractor entities employed
by Abbott that are assigned user roles. All users are required to receive training for features in which
they have the ability to execute. The application has several user group distinctions.
Role and Responsibilities
• Analyzed and understood the functional specification of the application
• Involved in designing of Test Scripts based on the requirement document
• Involved in designing and dry run and Formal execution
• Involved in Process related activities (C20, WSR and Risk Portal)
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4. Arun Sivakumar
Project 2:
Title ADD GS1 GDSN UDI Expansion
Duration April 2014 to July 2014
Role Team Lead (Offshore)
Testing Management Tool Lotus Notes (NPV)
Project Description:
In 2013 the FDA published a Unique Device Identifier (UDI) Rule requiring that additional attributes be
added to the GDSN solution and published to a new FDA Global Unique Device Identification Database
(GUDID) by Sept. 23, 2014 for all Class III/BLA products. Therefore this integration will be enhanced to
include data mapping from ADD’s GS1 MT Tool system to the LANSA Data Sync Direct application for the
new UDI attributes required by the FDA. This enhancement will include the ability to load, register and
publish these new UDI attributes into 1WS for ultimate publication to the new FDA GUDID database.
This enhancement will also require that data received through this integration be validated. GS1 MT
Release 5.0 contains Validation Testing for GS1 UDI attributes creation and maintenance in GDSN
module to correlate and satisfy FDA UDI Final rule.
Role and Responsibilities
• Analyzed and understood the functional specification of the application
• Involved in designing of Test Scripts based on the requirement document
• Involved in designing and dry run and Formal execution
• Performed a team lead role and POC for test deliverables from offshore
• Involved in Process related activities (C20, WSR, MSR, Risk Portal, Process Audit)
• Got excellent feedback and appreciation from customer for the successful completion of
the project
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5. Arun Sivakumar
Project 3:
Title ADC Quality Hold Database
Duration Jan 2014 to June 2014
Role Team Lead (Offshore)
Testing Management Tool Lotus Notes
Project Description:
Quality Hold Database application is a web-based application primarily used by the Product Quality
Assurance Analyst (PQA) in Abbott Diabetes Care(ADC) to record the Quality Holds and its affected
materials information along with the Inventory Responses (IR), Disposition IR. The application will act
as a repository of data which contains details about the Quality Holds that are handled by ADC. The
PQA representative who accesses the system will import the data as part of the Quality Hold. The
application’s Reporting feature will enable the user to generate standard reports with limited
customization.
Role and Responsibilities
• Analyzed and understood the functional specification of the application
• Involved in designing of Test Scripts based on the requirement document
• Involved in designing and dry run and Formal execution
• Performed a team lead role from offshore
• Involved in Process related activities (C20, WSR, MSR, Risk Portal, Process Audit)
• Got excellent feedback and appreciation from customer for the successful completion of
the project
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6. Arun Sivakumar
Project 4:
Title ADD GS1 GDSN
Duration August 2013 to Dec 2013
Role Team Member (Offshore)
Testing Management Tool Lotus Notes (NPV)
Project Description:
For a variety of regulatory and business related reasons, industry (e.g. Group Purchasing Organizations)
and regulatory organizations (e.g. FDA) within the United States and around the world are requiring
healthcare companies to implement the GS1 Standards. The GPO requirements specify that companies
with which they do business implement the various GS1 standards elements: Global Location Number
(GLN), Global Trade Item Number (GTIN) and Global Data Synchronization Network (GDSN) .
Role and Responsibilities
• Analyzed and understood the functional specification of the application
• Involved in designing of Test Scripts based on the requirement document
• Involved in designing and dry run and Formal execution
• Involved in Process related activities (C20, WSR and Process Audit)
• Got excellent feedback and appreciation from customer for the successful completion of
the project
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7. Arun Sivakumar
Project 5:
Title GPO MES POMSnet Testing
Duration July 2012 to till date
Role Team Member (Offshore)
Testing Management Tool HP Quality Center 10, HP Quality Center 11.
Project Description:
GPO MES POMSnet Testing project will allow the Global Manufacturing organization to incorporate the
R340.2 release of Honeywell’s POMSnet manufacturing execution system. POMSnet is a critical, 21 CFR
11 compliant application that manages production operations. This release will provide improvements
in recipe creation and management, new functionality around packaging, and improvements in
dispensing and specification management. The purpose and scope of this project is to document, test
and certify the POMSnet R340.2 upgrade for implementation within ABL, APL and Sligo. The scope will
also include testing the version with the interfaces to AES and KBM. This new version of the software
includes enhancements for packaging solutions, recipe creation and management through Bill of
Material parameters, as well as exception management. In addition to the software enhancements,
this project will provide new database servers for both APL and Sligo.
Role and Responsibilities
• Analyzed and understood the functional specification of the application
• Involved and gained knowledge in the core process of Validation testing.
• Involved in designing of Test Scripts based on the requirement document
• Involved in designing and dry run and Formal execution
• Got excellent feedback and appreciation from customer for the successful completion of
the project
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8. Arun Sivakumar
Project 6:
Title Integration Manager RTB Fixes
Duration May 2012 to July 2012
Role Team Member (Offshore)
Testing Management Tool Mercury Quality Center 9.2
Project Description:
Integration Manager RTB Fixes is to provide the fix to the high quality defects raised in Quality center.
This Integration Manager RTB Fixes project fixes the high priority bugs and anomalies registered in
Quality Center for Integration Manger (IM) application. It also performs QA on Windows, Linux, Solaris
and UNIX platforms, MS SQL & Oracle Databases.
System testing will be done to verify that all the requirements defined by the business for IM have been
met. Database testing is also done in order to verify that the data retrieval from the Global database
as well as the local database for further reference. The testing will encompass both positive and
negative test flows. Manual Regression Testing will be carried out to ensure the existing functionalities
of Integration manager are not impacted due to the fixes in the Integration Manager RTB Fixes.
Role and Responsibilities
• Analyzed and understood the functional specification of the application
• Involved in designing of Test Scripts based on the requirement document
• Involved in designing and dry run and Formal execution
• Got excellent feedback and appreciation from customer for the successful completion of
the project
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9. Arun Sivakumar
Project 7:
Title RA PPG-GLS 1.3
Duration September 2011 to February 2012
Role Team Member (Offshore)
Testing Management Tool Mercury Quality Center 9.2
Project Description:
Global GLS Labeling System) makes use of the Commercial off the Shelf (COTS) packaged software
called xmLabeling from Glemser Technologies. XmLabeling is a Documentum based solution for
managing global labeling content in Health Authority approved formats. XmLabeling manages product
labeling documentation such as US Package Inserts (USPI), Summaries of Product Characteristics
(SmPC), Developmental Core Data Sheets (DCDS), Company Core Data Sheets (CCDS) ERO CP/MRP/DCP,
and Local labels.
The Global Labeling System utilizes efficient and compliant global processes to create and manage
labels for every approved product in English and local foreign languages, as the business determines
the need for managing translations for different submission types. Currently only Centralized
Procedures are being managed within Global Labeling System. Documents are effectively version
controlled and stored in a single repository. The Global Labeling System will enable authorized users to
manage global labeling documents for submission to the FDA in Structured Product Labeling (SPL)
format, to the EMA for Centralized Procedures, and to national agencies in the form of Decentralized
Procedures and Mutual Recognition Procedures
Role and Responsibilities
• Analyzed and understood the functional specification of the application
• Involved in designing of Test Scripts based on the requirement document
• Involved in designing and dry run and Formal execution
• Got excellent feedback and appreciation from customer for the successful completion of
the project
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10. Arun Sivakumar
Project 8:
Title AP- iCIRCULAR
Duration June 2011 to September 2011
Role Team Member (Offshore)
Testing Management Tool Mercury Quality Center 9.2
Project Description:
The AP is one of the largest and most trusted sources of independent newsgathering, supplying a steady
stream of news to its members, international subscribers and commercial customers. AP is neither
privately owned nor government-funded; instead, as a not-for-profit news cooperative owned by its
American newspaper and broadcast members, it can maintain its single-minded focus on newsgathering
and its commitment to the highest standards of objective, accurate journalism. AP-iCircular is web
based application. It maintains the database of the customers under Associated Press.
.Role and Responsibilities:
• Analyzed and understood the functional specification of the application
• Involved in designing of Test Scripts based on the requirement document
• Involved in designing and dry run and Formal execution
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