SUMMARY

Over ** years of hands-on experience in Pharmaceutical, Financial, Health Imaging, E-Commerce and

Educational industries as a Validation/Qualification Engineer and Business Analyst. Extensively used automated tools like Unified Functional Validation (UFT), formerly known as QuickTest Professional (QTP), Selenium, ALM VERA, JIRA, WinRunner 7.6, Load Runner 7.8, Rational Suite (formerly SQA Suite), Microsoft Test Manager and Test Director 8.0.

Specific experiences include:

Analyzed functional Requirement Specification and System Design Specifications

Performed different types of Validation at different stages in the Software Development Life Cycle (SDLC).

Developed and Reviewed Validation Plans, Qualification Plans, Validation Procedures and Validation Reports, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.

Created Validation Scripts from the Business Requirements and also from the Use Cases by analyzing and identifying Scenarios from the existing Unified Modelling Language designs (UML’s)

Involved in EDI Validation with Inbound and Outbound data exchanged between different systems.

Used SAP as part of the Interface Validation for Processing Customer and billing information.

Involved in Authoring and Reviewing all the Computer System Validation deliverables, FDS, QAP, Validation Plan, Validation Summary Report, Traceability Matrix.

Has demonstrated skills in Requirements gathering, Test case preparation, Validation and UAT of Documentum (Enterprise Content Management)

Hands - on experience in implementation of various IT processes on ServiceNow such as Incident and Problem Management, Change Management, HR Catalog, Service Catalog and other ServiceNow modules.

Great IT Service Management (ITSM) experience in Service Catalog, Requirement Fulfillment, Self Service Portal, Incident Management, Change Management, Problem Management, Learning Management on ServiceNow platform.

Experience gathering and documentation of requirements, citations, acceptance criteria and other artifacts using the SDLC application in ServiceNow.

Authored protocols, reports while as per the change management process.

Write and review extensive sets of test scripts used for Validation in ServiceNow

Extensive experience in Security, System Validation, functional Validation, integration testing, regression testing, User Acceptance testing, black box testing, GUI testing, back-end testing, browser compatibility testing, IVRS testing and load/performance testing on Windows and Unix environments.

Validated the product as per the quality system Regulations for Medical devices (Current good manufacturing practices part 820) while working on Health Imaging products.

Working knowledge of Good Automated Manufacturing Practices (GAMP 5) risk-based approach

Provided Validation services in achieving the 21 CFR PART 11 (Electronic Records & Signatures) compliance to assure successful data quality and data integrity to, and FDA challenge.

Involved in supporting the CAPA implementation steps.

Knowledge of QUMAS Doc Compliance, medical device quality management system (QMS) a regulatory content management for electronic control of all documentation and QUMAS Process Compliance, a workflow and process management for Deviations, CAPA, Change Control, Audit.

Involved in implementation and Validation of the IT Service Practices (Service level agreements, Change Request procedures etc)

Authored and Reviewed equipment validation protocols, IQ, OQ and PQ

Involved in Validating Reports developed in Cognos using SQL Queries.

Co-ordinated and Performed Production deployments consisting of objects and SQL executions.

Involved in Creation of Confluence pages showing Business process.

Identifying, Tracking Issues and Problem Resolution using ALM, JIRA.

Customer, Contracts Management, Wholesaler Chargebacks Submission using Model N, CARS applications.

Involved in validating IT systems supporting Regulatory affairs.

Collaborated in Submission of Regulatory Applications based in SharePoint.

Hands-on experience of Validation on mobile platforms such as Android, RIM, Windows and Apple

TECHNICAL SKILLS:

Operating Systems

Unix, Linux, Windows 95/98/NT/2000, XP,MS-DOS

Languages

C, C++, Visual Basic, HTML, TSL, XML, ASP, JavaScript, VB Script, J2EE and PHP

Database

Oracle 8i, SQL Navigator, SQL Developer, Toad, MS-Access, MS-SQL Server 2005, MySQL and DB2

Web Server

IIS 4.0/5.0 and Tomcat Apache

Application Server

Web logic Server, Silver stream Server

Middleware

Webmethods

Validation Tools

Selenium, Unified functional Testing (QTP), Win runner 7.6/6.0, Load Runner7.8/6.0, Rational ClearQuest and Microsoft Test Manager 2013

Content Management Systems

Documentum, Word Press, SharePoint, Sitecore, Umbraco,

E-Commerce, QUMAS, Veeva Vault

IT Service Management Tools

Remedy, ServiceNow

Contract Systems

Model N, CARS (Revitas)

Bug Tracking System

HP ALM Vera, Test Director 8.0/7.x, Harvest, PVCS tracker, Clear Quest, DDTS, Jira, Spira

ERP Packages

SAP

Mobile Devices

Android, blackberry, Windows and Apple

Browsers

Internet Explorer, Firefox, Chrome and Safari

Professional Experience

Bristol Myers Squibb --- Validation Lead March 2021 to Present

Bristol Myers Squibb is the world’s leading biopharma company firmly focused on its mission to discover, develop and deliver innovative medicines to patients with serious diseases that transforms patients lives through science.

Facilitating the Regulatory Applicability & Risk Assessment process with stake holders, business and System Owner.

Involved in the Vendor (Supplier) Assessment process identifying the supplier risk identifying the overall risk of the system being validated.

Providing CSV support for implementation and validation of GxP systems in accordance with corporate policies and procedure.

Hands-on experience in orchestrating end-to-end Validation Lifecycle Implementation for software systems.

Facilitating the creation of user requirements for systems requiring validation through business analysis/collaboration with system vendors and business owners.

Drive conversations between vendors, business owners, and IT laboratory systems technical staff to ensure all aspects of system functionality and technical constraints are known to ensure system validation is robust and that systems are fit for use.

Authored validation deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.

Perform gap assessments of user requirements against vendor protocols to identify gaps and author test cases to address gaps.

Ensuring testing protocols address appropriate regulatory requirements to ensure Patient Safety, Product Quality, data integrity (i.e., 21 CFR Part 11).

Facilitate execution of protocols and perform a technical review of executed protocols. Manage all aspects of validation deliverables, both vendor and company generated.

Ensure timely completion of projects based on pre-established timelines.

knowledge of R&D systems and data generating, application-based equipment/instrumentation systems used in GLP and GMP laboratories.

Experience developing and managing CSV programs in a cGMP environment.

Trained other members of the teams in CSV, ALM and other processes.

Merck --- Senior Validation Engineer Nov 2016 to March 2021

Merck is one of the leading pharmaceutical companies implementing Model N Contracts Management containing Contracts pricing, Govt pricing, Medicaid, Medicare. Involved in multiple projects as a lead QA/BA.

Responsibilities/Accomplishments:

Worked with business analysts and developers to prepare test requirements.

Involved in Creation of Confluence pages showing Business process, SOP.

System Validation performed using the GAMP 5 risk-based approach evaluating and categorizing the system.

Specifications, test scripts and other documentation based on the GAMP 5 Validation approach.

Involved in creating use cases, test plans and test reports and technical design documents.

Involved in Interface Validation using CARS, Model N and other third-party applications.

Prepared Low level Test Scripts covering Customer, Contracts, Ship To Accounts, and Membership areas

Performed Contracts Management, Customer Management, Chargeback Validation in Model N

Managing, Updating Customer info using Integrated Customer View (ICV) application in standardization of Customer data.

Perform electronic records and signature validations, Regression Testing, GUI & Functionality Validation based on the Test Strategy using ALM VERA

Digital workflow Validations in compliance with industry eSignature standards, including CFR Part 11

Involved in CQV (Commissioning, Qualification, and Validation) process, validating equipment and systems in compliance with policies, guidelines and procedures.

Authored lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems.

Involved in creation/review/approvals of IQ/OQ/PQ protocols, specifications, plans, and reports, and other documentation.

Working knowledge of International Society for Pharmaceutical Engineers (ISPE).

Involved in Authoring, Reviewing and Updating Standard Operating Procedures (SOP’s) so each one adheres to the regulations.

Worked on Validation of Model N Reports and reports generated in Jorvak Analytics & Reporting (JAR)

Performed Issue Tracking, Incident Reporting and Problem Resolution using JIRA, ALM

Co-ordinated and Performed Production deployments using SVN (Subversion), Bitbucket, SQL Navigator for execution of SQL Scripts.

Involved in creating work instruction documents as per the company regulations so each one can perform the tasks in an established manner.

Involved in creation of User guides and quick reference documents for the business users.

Provided support on equipment qualification issues, investigations, deviations and CAPA actions.

Agile scrum methodology followed for the sprint-based project deliverables using JIRA boards

Environment: Windows 10, Model N, ICV, Midas, Webtop, VEEVA VAULT, ALM VERA, JIRA, Confluence, SVN, Bitbucket, SQL Navigator, JAR

Glaxo Smith Kline --- Senior Validation Engineer Oct 2014 to Oct 2016

Glaxo Smith Kline is one of the leading Pharmaceutical companies implementing CARS Contracts Management containing Contracts pricing, Govt pricing with eCommerce integration. This is an eCommerce platform where multiple systems have been integrated in to one.

Responsibilities/Accomplishments:

Worked with business analysts and developers to prepare Validating requirements

Used Microsoft Test Manager for System, Functional/Non-Functional, Regression, UAT testing, defect triage, change management/issue management

Execute Sanity Script after each Release or build to check the high-level functionality of the application

Involved in Authoring, Reviewing, Updating Validation Plan, Validation Scripts and Validation reports.

Involved in Interface Validation using eCommerce, CARS and other third-party applications.

Prepared Low level Validation Scripts covering Contracts, Ship To Accounts, and Membership areas

Perform Regression Testing, GUI & Functionality Validation based on the Test Strategy

Performed a Connectivity Check process before each Release or build to check the Interface connectivity

Used Hybris for creating Customer data, Products and Pricing

Verified the data received, processed and sent by Hybris, CARS, E1 interfaces (Ship to account, bill to account, Contract Membership Requests)

Involved in setting up test environment and Creation of Validation data for Trading Partners, Contracts.

Involved in preparing the Traceability Matrix and perform a Gap analysis

Performed Exploratory testing using Microsoft Test Manager.

Involved in Collaborating with business Analysts for User Acceptance Testing, Production issues and providing the report and feedback to the Management

Involved in Authoring, Reviewing and Updating work instruction documents as per the company regulations so each one can perform the tasks in an established manner.

Involved in Authoring, Reviewing and Updating User guides and quick reference documents for the business users

Environment: Windows XP Professional, CARS, Hybris, E1 System, Microsoft Visio

MRY – Senior QA Analyst June 2011 to Sept 2014

MRY is a creative and technology agency dedicated to making brands remarkable. MRY works with clients to give consumers something worth talking about—brand content that sparks emotion that adds value and inspires action.

Responsibilities/Accomplishments:

Worked with User Experience, Business analysts and Project Managers to gather and prepare Validation requirements for multiple projects simultaneously.

Interacted with Clients in defining and Validating the requirements.

Used Microsoft Test Manager for System, Functional/Non-Functional, Regression, UAT testing, defect triage, change management/issue management

Created Manual Scripts as per the defined specifications.

Interactive with back end and front-end developers in resolving the applications issues.

Reported Status during everyday Status meetings as per the agile methodology.

Involved in preparing approvals for the Change Request Qualification

Validation performed in accordance with the Quality system regulations for Medical devices (Part 820).

Collaborate with the User Experience teams in making usability decisions on websites/mobile

Involved in A/B testing of Campaigns, Newsletters

Collaborate with the business teams in resolving production issues and maintain the sites.

Provided services in compliance with the 21 CFR Part 11 Regulations to assure successful data quality and data integrity to FDA challenge.

Collaborate with the Clients (Financial, Pharmaceutical, in preparation of functional requirements, user requirements, data set up, setting up user acceptance testing etc

Clients include BNY Mellon, Johnson & Johnson, Moleskine, Sony, Microsoft

Coordinated and overseen validation of all FDA regulated software systems Company wide.

The framework for Monitoring field Trials, Electronic Records and signatures FDA Auditing of Computerized Systems and 21 CFR Part 11.

Involved in creating work instruction documents as per the company regulations so each one can perform the tasks in an established manner.

Involved in creation of User guides and quick reference documents for the business users

Analyze Results and provide evidence using Bugzilla, Jira and Spira.

Performed functionality, Cross browser Validation on PC and Mac.

Performed functionality testing, UI on Mobile devices for responsiveness.

Environment: PC, Mac, Web applications, Mobile Apps, Microsoft Test Manager, Share Point, Team foundation Server (TFS), Safari, User testing websites (Survey Monkey & Usertesting.com), Android and iPhone.

Interactive One – Senior QA Analyst May 2010 to May 2011

Interactive One is a pioneer in the digital Media space, inspiring the black community by providing the best online Products, Programming and Services. Currently publishes three largest niche-targeted Communities, BlackPlanet.com, Asian avenue and MiGente.com, 7 Content Verticals and around 50 Radio Stations.

Responsibilities/Accomplishments:

Worked with business analysts and developers to gather and prepare test requirements using HP Quality Center.

Created Reusable scripts saving lot of time and resources so that the team can use the Reusables to create test scripts depending on the requirement.

Used automation framework for a standard approach to drive and execute the scripts.

Single data table to retrieve data for all the actions involved for one complete requirement.

Created and used user defined functions and also used Regular Expressions

Created and Automated tests using Quick Test Professional 10.0

Work on back end testing using SQL queries when loaded into the application.

Created Automated Test Scripts based on the Requirements listed in HP Quality Center and Linked the Test Scripts with the Requirements.

Parameterized Scripts using Data Tables, Environment and Random Number options.

Execute Sanity Script after each Release or build which saves time and resources to check the high-level functionality of the application

Execute Regression Scripts to verify if the basic functionalities are intact.

Scheduled Execution of the Baseline Scripts regularly using Test Run Scheduler

Analyze Results using HP Quality Center

Performed testing on mobile platforms such as Android, RIM and Apple devices and also on simulators

Performed functionality, browser-based testing on web applications, configuring the objects in WordPress and verifying the same in the UI

Environment: Windows XP Professional, WordPress, A/B Testing, Web applications, Internet Explorer, Quick Test Professional 10.0 and HP Quality Center 9.0

Celgene Pharmaceuticals --- Validation/Quality Engineer April 2009 to April 2010

Celgene Corp. is a pharmaceutical company primarily engaged in the discovery, development and commercialization of small molecule drugs designed to treat cancer and immunological diseases through gene and protein regulation. Celgene’s pharmaceutical products, Thalomid and Revlimid, are managed by the company’s Risk Minimization Action Plans to reduce the side affects. Celgene is committed to operating a global Risk Management program. To support this expansion, Celgene needs a computer system to provide a global framework which can easily adopt each country’s language and regulatory requirements.

Responsibilities/Accomplishments on the PRPC project:

Worked with Subject Matter Experts and developers in finalizing the business requirements

Created Automated Test Scripts using Quick Test Professional 10.0 based on the Requirements listed in HP Quality Center.

Created Reusable Validation scripts saving lot of time and resources so that the team can use the Reusables to create test scripts depending on the requirement.

Used automation framework for a standard approach to drive and execute the scripts.

Single data table to retrieve data for all the actions involved for one complete requirement.

Created and used user defined functions and also used Regular Expressions

Involved in creation of Reports Scripts to Validate 100 Inbuilt Cognos Reports. In order to save tome critical Reports were validated.

Reports were Validated by executing the scripts which consisted of Pre-requisite data creation, followed by Report generation steps and then by executing T-SQL Queries using SQL Server 2005

Validated the Report so that the record number, Headers i.e. column names displayed in the created Report is the same as the records displayed in the Query

Perform Integration Testing, Regression Testing, GUI & Functionality Testing based on the Test Strategy

Retrieved data from the Mainframe application.

Involved in preparing the Requirement Traceability Matrix and perform a Gap analysis

Tracked bugs using HP Quality Center and compiled daily, weekly and monthly reports

Worked on Grammar files to recognize the prompts

Worked with Nuance Server for the IVRS prompts recognition

Use of SQL server and Oracle with CallMaster to write the data to and from the database

Scheduled scenarios for Validating the IVRS, and extensive use of multiple channels for Validation

Performed mobile testing on device platforms such as Android, RIM and Apple and also on simulators

Environment: Quick Test Professional 10.0 and HP Quality Center 9.0, ERP, PegaRules Process Commander 5, SQL Server 2005, CallMaster FX-TDM, Cognos and Internet Explorer

Bristol-Myers Squibb Company --- Senior Validation Engineer Sep 2006 to Mar 2009

Bristol-Myers Squibb is one of the leading Pharmaceutical companies implementing Model N Contracts Management and Government Pricing for BMS and NOVO Realms

Responsibilities/Accomplishments:

Worked with business analysts and developers to prepare Validation requirements

Involved in implementing test plan and Maintain Validation scripts in HP Quality Center which is a repository for saving the requirements and Validation Scripts.

Created Automated Validation Scripts based on the Requirements listed in HP Quality Center and Linked the Test Scripts with the Requirements.

Execute Sanity Script after each Release or build to check the high level functionality of the application

Scheduled Execution of the Baseline Validation Scripts regularly using Test Run Scheduler

Involved in Interface Validation using SAP, Model N and other third party applications.

Prepared Low level Test Validation covering Contracts, Chargebacks, and Membership components of Model N

Cognos Reports were Validated by executing SQL Queries using SQL Server 2005

Cognos Reports were Validated by executing the scripts followed by Report generation steps and then by executing T-SQL Queries using SQL Server 2005

Validated the Report so that the record number, Headers i.e. column names displayed in the created Report is the same as the records displayed in the Query

Cognos Reports were manually analyzed by validating some records in the beginning, some records in the middle and lastly some records in the end to ensure that the same records are being displayed in the Report and also in the executed Query.

Perform Regression Testing, GUI & Functionality Validation based on the Test Strategy

Performed a Connectivity Check process before each Release or build to check the Interface connectivity

Used SAP for creating Customer data and executing the billing cycle for Chargebacks

Involved in EDI Validation (X12 Format) verifying the Contracts (845’s) and Chargebacks (849’s) data received by the Wholesaler.

Worked closely with the GXS team in resolving the EDI issues.

Used Toad for performing Back end Validation for Reports

Verified the data received, processed and sent by Middle ware (Webmethods)

Involved in preparing the Traceability Matrix and perform a Gap analysis

Involved in Analyzing the Risk and creating a Risk Assessment document

Environment: Windows XP Professional, J2EE, Webmethods, SAP, Cognos, websphere, SQL Server 2005 and Internet Explorer

Community Connect Inc -- QA Tester Jan 2006 to Aug 2006

Community Connect Inc. is the leader in online community destinations for US ethnic groups. We currently publish the three largest niche-targeted communities: AsianAvenue.com, BlackPlanet.com and MiGente.com.

Responsibilities/Accomplishments:

Worked with business analysts and developers to prepare test requirements using HP Quality Center

Created and Automated tests using Quick Test Professional 9.0

Well-defined test cases and data to be prepared, to test boundary testing, negative testing.

Risk based Validation approach was used to test the main functional aspect of the application.

Work on back end testing using SQL queries when loaded into the application.

Perform Regression Testing, GUI Testing & Functionality Testing using Quick Test Professional.

Created Automated Test Scripts based on the Requirements listed in HP Quality Center and Linked the Test Scripts with the Requirements.

Parameterized Scripts using Data Tables, Environment and Random Number options.

Execute Sanity Script after each Release or build which saves time and resources to check the high level functionality of the application

Execute Regression Scripts to verify if the basic functionalities are intact.

Scheduled Execution of the Baseline Scripts regularly using Test Run Scheduler

Analyze Results using HP Quality Center

Used Load runner to develop Vuser scripts for Performance.

The performance Scripts were later modified for load testing using Check points and Rendezvous points.

Parameterized the LoadRunner Vuser scripts

Used Correlation capturing the dynamic values passed from the server to the client.

Environment: Windows XP Professional, Java, Web applications, Internet Explorer, Quick Test Professional 9.0, Loadrunner 9.0 and HP Quality Center 8.2

Novartis Pharmaceuticals - Validation Engineer Oct 2005 to Dec 2005

The CARE (Clozaril Administration Registry Enrollment) Application is a Clinical Trials Application in which the blood Values of the Patients who are on the Clozaril drug are being Monitored. There are several kinds of Users Accessing the System with different privileges.

Responsibilities/Accomplishments:

Leading the QA Effort on the Clinical Trials Application

Developing Manual Scripts basing on the Requirements documented in the URS

Developed Scripts basing on different Scenarios for different blood counts

Also developed Scripts basing on the CFR Part 11 Regulations

QTP was used to develop Scripts for Sanity Testing.

Generated QTP Scripts with Checkpoints and Synchronization Points

Multiple & Reusable Actions were created.

The Reusable Actions were Executed by copying and also by Inserting a Call to the Script

Scripts were parameterized using DataTable parameters and Environment Variables

Output values were Retrieved and passed as parameters to the other Actions

Regular Expressions were used for the varying Window Labels

Developed Integration test Scripts basing on the functional requirement.

Defect tracking and reporting done in Rational Clear Quest.

Environment: Windows XP Professional, Java, Web applications, Tomcat Apache, Quick Test Professional, CFR Part 11 Validation, Rational Clear case and Clear Quest.

Pfizer Inc --- QA Tester Feb 2005 to Sept 2005

Project: Field Force org (FFO)

The FFO Project is a project for the Pfizer Sales force. Around 120 applications including Sherlock, Betsy 3.1 and Olos are part of the 8 Images or Roles that are part of the project. The platform for these Images or Roles is being changed from windows 2000 to Windows XP SP1. These Images would be installed on the laptops and Tablets basing on the Roles they represent.

Responsibilities/Accomplishments:

Analyzed the Functional Design documentation, User Requirements and

Technical Requirements Specifications.

Performed Installation Validation on the Applications that have been packaged using Wise Package Studio 5.5

Developed Installation Scripts for Installation testing

Written functional test Scripts using Quick Test Professional analyzing the possible Scenarios in Windows and Web Environments.

Generated QTP Scripts with Standard, Text, Bitmap, Table Checkpoints and also Synchronization Points

Scripts were parameterized using the DataTable parameters, Environment Variables and Random Number Parameters

Output values were Retrieved and passed as parameters to the other Actions

Regular Expressions were used for the varying Window Labels

Executed the QTP Scripts and passed Messages to the Log using the Report feature

Developed Integration Test Plans, and Test Schedules to assist in the execution of functional, System Validation, Regression Testing, Integration Testing and User Acceptance testing.

Scheduled Test Procedure Design Reviews in accordance with the procedures and regulations.

Written functional test Scripts for the applications which includes Sherlock 3, Betsy, Olos, Stork, Sherlock Analyzers, PPMG, XMS and Orion

Performed functional Validation by executing the QTP Scripts from Test Director

Developed Integration test Scripts basing on the functional requirement

Executed Integration Scripts for all the specified Roles basing on the Image that has been Installed

Environment: Web aps, Wise Package Studio 5.5, Quick Test Professional 8.0.

Kodak, Allendale, NJ -- Validation Engineer Aug 03 to June 04

Project Worked: Direct View (Medical Imaging)

Web-based application consolidates reading, reviewing DICOM and non-DICOM images, 3D processing, archiving and distribution. Archiving and viewing for DICOM images.

Responsibilities/ Accomplishments:

Validation performed in accordance with Quality system regulations for Medical devices (Part 820).

Provided services in compliance with the 21 CFR Part 11 Regulations in its System Development Life Cycle (SDLC) and SQA services to assure successful data quality and data integrity to any FDA challenge.

Process Validation has been performed and followed so that the manufacturing process adheres to the Specifications of the CFR part 820 regulations.

Installation Qualification, Operational Qualification and Performance Qualification Procedures have been documented and followed.

The framework for Monitoring field Trials, Electronic Records and signatures FDA Auditing of Computerized Systems and 21 CFR Part 11.

Supported the successful implementation of manufacturing and laboratory equipment.

Environment: Windows 2000 professional, ObjectStore, Visual C++, Clear Quest and DOORS.

EDUCATION

Masters in Commerce, INDIA

Masters in Information Systems, Australia

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