Anitha R

Bengaluru
[email protected]
+91-9036333676

Key Expertise
Seasoned Software Testing professional with 9+ years of experience in medical device testing, manual
testing, mobile and web application testing. Proficiency in computer system validation (CSV) and computer
software assurance (CSA). Proven track record in leading validation activities, ensuring adherence to FDA
and GxP. Expertise in Healthcare domain.

Experience Summary

• Worked as Senior Quality & Reliability Engineer for TE Connectivity, Bengaluru from Mar 2024 to
till date.
• Worked as Senior QA Analyst for IQVIA, Bengaluru from Aug 2022 to Feb 2024.
• Worked as Engineer in the L&T Technology Services Ltd, Bengaluru from Oct 2018 to Jul 2022.
• Worked as Test Analyst for Torry Harris Business Solutions, Bengaluru from July 2017 to Oct 2018.
• Worked as Software Test Engineer for Power Sparrow India Pvt Ltd, Bengaluru from March 2016
to June 2017.

Work Summary

• Administered and handled the team of 6+ test engineers for various Verification & Validation
programs offshore to streamline the day-to-day activities.
• Experienced in training/mentoring about the product and the processes followed in the
organization to the new joiners/team members. 3+ years of experience in leading and managing
a team.
• Have good knowledge in testing medical devices and expertise in non-product tool validation and
its process.
• Worked as a part of scrum team and involved in requirement analysis, developing and reviewing
test scenarios and test cases, executing test cases, test data creation, end to end test case
creation.
• Identification of test data, design of test release plan, test execution plans, analyzing test results,
defects Tracking and issues closure.
• Expertise on Functional Testing, System Testing, Regression Testing, Integration Testing, GUI
testing, and Black box testing.
• Excellent Hands-on experience in defect life cycle and in tracking/logging defects using “Defect
tracking” tools.
• Well versed with all the stages of Software Development Life Cycle (SDLC), Defect Life cycle,
testing techniques, testing methodologies and hands on experience in Test process and Software
Testing Life Cycle (STLC) and Agile Methodology.
• Experience in the analysis, development, implementation and testing of full life cycle applications,
testing/managing issues related to the project in accordance with organization quality process.
• Experience in preparation and review of validation protocols IQ/OQ/PQ documentation, VP, SRS,
RTM, CSRA, RMR, Change Form, Scripted/Unscripted test cases and VSR.
• Experience in generating and reviewing Computer Systems Validations CSA/CSV deliverables
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 according to 21 CFR Part 11 and FDA regulations.
• Working experience in ensuring the compliance (GAMP 5 guidelines) and functionality of
computer systems within regulated industries.
• Corrective action and preventative action (CAPA) investigation and complaints.
• FDA Quality Systems Regulations Title 21 CFR Part 11, Risk management (ISO 14971) and Quality
Management System (QMS) standard for medical devices (ISO 13485).
• Issue and risk management- timely escalation and action, issue forecasting.
• Flexible and versatile to adapt to any new environment and work on any project. Quick learner
and excellent team player, ability to meet tight deadlines and work under pressure.

Skills
Operating System Windows and Linux family
Databases SQL Server 2008, Toad for SQL, Microsoft Access
Scripting Languages Java Basics
Automation Tools Selenium Basics, Mabl
Test Management Quality Center, JIRA, HP ALM, Test Trail, Q test, Test track, Bugzilla, Pulse,
WinSCP, pgadmin, Azure Container, Microsoft Access DB
Web Application Server Apache Tomcat

Project Details

Project 1
Duration Mar 2024 to Oct 2024
Project Name IQVIA-SmartSolve 11 2024 R1.1
Team Size 2
The implementation of upgraded system will provide a global solution that will help
standardize QMS processes. This will address a few of the high priority issues currently
facing the organization. Some of the processes being looked at as part of the EQMS
Description
implementation are NC management, CAPA management, Audit management,
Document management, Training management, Change management and Complaints
management modules.
Role: Senior Quality and Reliability Engineer
• Involved in understanding preparing the business requirements (UFRS),
creating validation plan, test protocol and involved in creating traceability
matrix and test summary report.
• Preparation of validation scripts-scripted/unscripted and verifying the
Role & requirements related to CFR Part 11.
Contribution • Involved in risk meetings for categorizing risks for each of the workflows and
business requirements.
• Create/update risk management plan as applicable with validation approach
to have sufficient test coverage.
• Performed risk assessment and developed validation master plans to ensure
the reliability and compliance of critical systems.
Tools Microsoft Access DB
Project 2
Duration Aug 2022 to Feb 2024
Project Name IQVIA-RIM Smart Validation
Team Size 6

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 The RIM Smart v5.0, 5.1, 5.2, 5.3 and 5.4 release is considered a GAMP 5 category 3
system, off the self and minimally configurable. IQVIA’s RIM Smart 5x, consists of
modules split into 3 major classifications, as Platform, Labeling and Submission
Description
Content Management. The individual modules are part of Salesforce App Exchange and
would be available for customers to install and take advantage of the pre-developed
solutions for organization specific requirements.
Role: Senior QA Analyst
• Involved in understanding preparing the business requirements (UFRS),
creating validation plan, test protocol and involved in creating traceability
matrix and test summary report.
Role & • Preparation/Execution of the validation scripts (IQ/OQ/PQ/VQ) and verifying
Contribution the requirements related to CFR Part 11.
• Involved in risk meetings for categorizing risks for each of the workflows and
business requirements. And meetings with BA, PD and QA.
• Create/Update risk management plan as applicable with validation approach
to have sufficient test coverage.
Tools JIRA, pgadmin, WinSCP, Azure Container
Project 3
Philips Duration Aug 2020 to Aug 2021
Project Name ECR V&V Support -NPSS Remediation
Team Size 8

ECR V&V Support -NPSS Remediation includes new and existing NPSS that is purchased,
delivered, downloaded or custom developed, and incorporated into the ECR Quality
System. These include commonly available Off-the-Shelf and Open-Source products,
whether fully licensed, free or for demo purposes. It also includes validation
Description requirements for software used to automate device production processes, device
design, testing, component acceptance, manufacturing, labeling, packaging,
distribution, complaint handling, or to automate any other aspect of the quality system
or as part of the Philips ECR quality system, and includes software used to validate
other non-product software.
Role: Senior Validation Engineer
• Involved in understanding the business requirements, creating validation
plan, test protocols and execution of the validation scripts (IQ/OQ/PQ).
Role &
• Involved in risk meetings for categorizing risks for each of the workflows and
Contribution
business requirements.
• Involved in client discussions and meetings and involved in creating
traceability matrix and test summary report.
Tools DMS, eDMR, SVN
Awards &
“Star of the month” award for single-handedly executing multiple tools
Recognition
Project 4
Duration Apr 2019 to Dec-2020
Project Name Philips- ACG
Team Size 2
It is a web based and mobile application which helps in providing care to recipient
Description (elderly people) by caregiver (family members). Philips Cares Aging & Caregiving
service is a digital experience that enables people to easily form and activate a care

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 circle of trusted family and friends, access meaningful insights into their elderly people
wellbeing and receive notifications about care.
Role: Quality Assurance Engineer
• Follows Agile methodologies for software development.
• Involved in requirement gathering and involvement in preparation of test
procedure, test scenarios, test cases, test data and review of the test
documents.
Role & • Perform the smoke testing to ascertain that the critical functionalities of
Contribution the program are working fine.
• Responsible for functional testing using black box testing techniques.
• Involvement in test execution, result analyzing and defect reporting.
• Find defects and classify them based on severity and priority in JIRA.
• Perform the retesting and regression testing.
• Attending the client calls on weekly basis and sending the status reports
Environment Chrome, Safari, iOS, Android

Tools Q-Test, JIRA

Project 5
Duration Oct 2018 to Mar2019
Project Name Cell Viability Analyzer
Team Size 7
The Scout - Cell Viability Analyzer is a video imaging system for analyzing cells in culture
media or in suspension. It automates the widely accepted trypan blue dye exclusion
Description protocol and is designed to analyze a wide variety of cell types. The software includes
features to monitor bioreactors and other cell culture processes and is designed to
comply with the US Food and Drug Administration (FDA).
Role: Test Engineer
• Requirement analysis, test plan preparation, writing test cases for the featured
requirements, review test cases, defect raising.
• Performed Sanity testing for each new build of the application.
Role &
• Coordinating with developers for bug fixes and issue resolution.
Contribution
• Supporting and helping team, tracking daily activities and involved extensively
in preparing Estimation and test strategy.
• Carried out functional, GUI, regression, compatibility, exploratory and
installation testing.
Environment Physical Medical device, Chrome

Tools JIRA, Test Trail

Educational Qualification & Certifications

• Bachelor’s in Computer Science Engineering from Visvesvaraya University, Belgaum.
• Technical courses on Software Testing Course at ‘QSpiders Testing Training Institute’. The course
contains Manual Testing as well as Automated Testing (Java Selenium) of Software.