Summary
Overview
Work History
Education
Skills
Timeline
Status
Generic
Open To Work

Sonal Jani

Wayne,NJ

Summary

20+ years of IT experience working as QA Analyst, Business Analyst, Project Manager, QA Lead/Validation Lead, QC Specialist and Business Quality Manager. Experienced working with diversified industries, including Banking, Pharmaceutical, ecommerce, manufacturing etc. with proven ability to articulate business values. Capable of adopting any business terminology in a short period of time. Experienced managing onshore and offshore QA teams. Experienced with Integration Testing, Functional Testing, Performance testing, database, User Acceptance testing, manual and some automated testing. Experienced leading/testing iPhone and Android platform. Functional experience with concentration on Use Case modeling using UML, Change Management, Ecommerce, mobile, Salesforce CRM, Technical Training, Software Development methodologies, QA/System Testing of client server and web-based systems. Extensive experience with User training and creating training document. Capable of working as a great team player and can also work independently. Technically resourceful in different types of testing such as Functional/Regression/System/Integration / Volume / Load / Stress Testing. 7+ years of experience in FDA regulated environment. Six years of experience working on deck system (electronic data capture) such as Inform, RAVE. Did two assignments at Medidata (2005, 2006-7) testing their RAVE electronic clinical data management (eCDM) product to include CTMS and Electronic Data Capture (EDC). Supported pharmaceutical clients as: PFIZER, AMGEN, PROPHARMA, KING, ENZON, ROCHE, J&J, Boston Scientific. Possess a good knowledge and practice of Agile, Waterfall methodology. Possess a good knowledge STLC and SDLC. Experienced creating/maintaining heavy documentation including Business and Technical Specifications, Test Plan, Validation plan, UAT Protocol, Functional Test Cases, UAT use cases, Summary Reports, Bug tracking, reporting and Test Report preparation. Experienced in Import / Export / Load data to Oracle database. Experienced in back-end testing using SQL queries, generating reports to ensure data integrity and validate business rules. Knowledge and experience in FDA and EMEA regulations especially 21 CFR Part 11 and Annex part 11, ICH E2B guidelines, GxP (GMP/GCP/GLP) guidelines, GAMP (GAMP5), Quality Assurance regulations, and Good Documentation and Good Testing Practices. Excellent interpersonal and communication skills with clear understanding of business and ability to work independently or as a team member.

Overview

30
30
years of professional experience

Work History

Business Quality Manager (Contractor)

AstraZeneca Pharmaceuticals
Gaithersburg, MD
06.2021 - 03.2026
  • Roles and responsibility: As a Business Quality Manager (BQM), I am responsible for managing multiple system implementation and enhancement projects within regulated environments, ensuring alignment with business needs and compliance standards. I lead cross-functional business teams and oversee User Acceptance Testing (UAT) activities to validate computerized systems and ensure they are ready for production deployment. My role involves working on a range of systems, including Veeva Safety Vault, Oracle Argus Safety (Argus Integration), Oracle Analytics Server (OAS), as well as SAM, A-Class NLP (Natural Language Processing solution), and NGSMS, a SaaS-based Signal Management System.
  • Support system related projects during the systems life cycle, including, creating project related pipelines, managing projects and lead QA activities.
  • Regulatory Impact Determination (RID) - Assess different risks on a high level (GxP, privacy, legal hold, security, embargo etc.)
  • User Requirement Specification (URS) - Define what the system shall do and shall not do.
  • Functional Risk Assessment - Assess risk associated with each user requirement and outline what to do to mitigate them (execute certain testing, create SOPs for procedural controls, training, design of the system etc.)
  • Test Plan/Validation Plan (VP) - Outline overarching plan for validation effort.
  • Test Approach (TA) - Outline testing strategy for the validation effort.
  • Execute UAT Test scripts as required
  • Test Report (TR) - Document test outcome.
  • Traceability Matrix - Trace each requirement to each executed test script and test log of the test.
  • Validation Report (VR) - Document overarching outcome of validation effort.
  • Review and approve Periodic reports for each application.
  • Support Inspections and audits related to the Safety and Surveillance systems
  • Environment: Veeva Quality Vault cloud-based quality management system (QMS), Jira project management and issue tracking tool, Oracle Argus Safety

BA/Validation Test Lead/PM (Contractor)

EISAI Pharmaceuticals
Woodcliff Lake, NJ
05.2019 - 06.2021
  • Working with Oncology/Neurology business groups to understand their business needs to day-to-day activities. Working as BA/Test lead with applications called ECCE (Eisai Clinical Computing Environment) and DEX (Data Exchange) which helps business to create clinical studies/tasks and transfer/maintain clinical sensitive/non-sensitive data.
  • Role and responsibilities:
  • Managing multiple projects and UAT activities
  • Managing Offshore/Onsite QA teams
  • Review QA documentation and approve
  • Responsible for designing and developing and leading validation strategies and plan to ensure verification of the system and functional capabilities
  • IS Quality/validation on project with CFR Part 11
  • As BA Understand business needs and create user requirements
  • Work with system vendors to communicate business needs
  • Facilitate UAT meetings
  • Responsible for developing Validation plan, UAT protocol, Validation Summary Report
  • Review and maintain post UAT documents
  • Responsible for multiple validation, revalidation and change control activities
  • Work with business users as Test Lead to guide them for their UAT test activities
  • Perform testing when needed as BA and UAT Lead
  • Responsible for maintaining and managing all project documents on SharePoint
  • Environment: Manual 100%, Windows XP, Windows PE, TabletPC edition, SharePoint, Jira.Net

BA/ UAT Test Lead

GAF: Building Materials Corporation
Parsippany, NJ
07.2013 - 12.2018
  • Worked with web-based applications called Customer Zone, Contractor Zone
  • Role and responsibilities are listed below:
  • As BA Understand business needs and create user requirements
  • Work with system vendors to communicate business needs
  • Involved with iPhone and Android platform testing
  • Managing Offshore/Onsite QA teams
  • Review Business requirements/Functional specification and design documents with development and QA team to make sure they understand boniness needs.
  • Create Use Cases and user training documentation
  • Attend Project review meetings for upcoming projects to be prepared for future releases
  • Work with outsource team and transfer knowledge for each project prior to each release when needed
  • Create a Test Plan and detailed test cases
  • Execute manual tests including regression testing, system end-to-end testing, functionality testing, block box integration testing, and supported UAT before each release
  • Also ran automated scripts using UFT and analyzing the results
  • Work closely with Business Analyst and developers
  • Prepare test data for each test environments.
  • Provide daily status and follow up with the whole team in daily/weekly meetings
  • Also supported changes requests for different projects
  • Maintaining and managing all documents on SharePoint, ALM
  • User Jira to create user stories
  • Environment: Manual 90%, Automation Testing 10%, Windows XP, Windows PE, TabletPC edition, SharePoint, ALM and Clear Quest (Defect tracking tool), .Net

BA/ UAT Test Lead

The Hertz Corporation
Park Ridge, NJ
03.2011 - 07.2013
  • Worked with application called “Hertz Rent2Buy”. It is an innovative program designed to sell high-quality, used rental cars online at incredibly competitive prices. Testing application from all POS (Point of sales)
  • Role and responsibilities are listed below:
  • Review Business requirements/Functional specification and design documents to provide detailed estimates for all QA activities.
  • Involved with iPhone and Android platform testing for customer facing application
  • Attend Project review meetings for upcoming projects to be prepared for future releases
  • Work with outsource team and transfer knowledge for each project prior to each release
  • Create a Test Plan and detailed manual test cases
  • Execute manual tests including regression testing, system end-to-end testing, functionality testing, block box integration testing, smoke testing on production after each release
  • Work closely with Business Analyst and developers
  • Prepare test data for each test environments.
  • Environment: Manual Testing, Agile Methodology, Mobile testing, JIRA, TOAD, and Database MS SQL2008. .Net 4.0

QA Lead

Theknot Inc
Brooklyn, NY
03.2009 - 03.2011
  • Worked with listed below five major web-based applications. These websites are developed for one-stop wedding planning/buying home planning/ pregnancy planning solution. I worked on listed below projects:
  • Forums Theknot
  • Forums Wedding channel
  • Member Dashboard
  • The Bump
  • The Nest
  • Provided time and resource estimates for assigned tasks for input into test schedule.
  • Provided analysis support and skill mentoring to facilitate project needs. Represented department at various status and review meetings as required.
  • Worked closely with developers, Business Analysts, User Representatives and participated in the product design process including specification and other document reviews.
  • Supported the entire test process working with outsource team, getting involved early in the product development cycle and managing through product launch.
  • Developed and executed test scripts. Configured test environment for specific test cases, executed manual test, document results, and updated the defect tracking systems.
  • Participated in development and reporting of project metrics. Researched and recommended new test tools and techniques.
  • Performed End-to-End testing manually and automated tests as per test plan. Wrote and executed test script for the regression testing.
  • Environment: Manual Testing, TFS (Defect Tracking tool), JIRA, TOAD, frontend/backend is asp.net 1.0 C#, Database MS SQ

Test Coordinator- Tester

Boston Scientific
St. Paul, MN
07.2008 - 02.2009
  • Worked on a project called GPS web-based system (Global pre-clinical system), Data Management System (DMS) and EDC (Electronic Data Capture) for the Pre-clinical organization. The Electronic Data Capture (EDC) system is used by Pre-Clinical to capture animal study data. Under GPS, I have worked on four different projects as listed below.
  • DST- Data Capture Support tool
  • Global Library
  • Preclinical
  • OTSS
  • Responsible for coordinating and improving the QA process.
  • Creating Test Plans manually
  • Responsible for Creating, validating, and executing manual test scripts to include Functional Test, Boundary Test, Exception Test and Regression Test.
  • Recording and tracking software faults
  • Verifying test results and working with Development group in resolving software defects.
  • Creating Test Summary Reports.
  • Creation and update of Traceability Matrix to ensure that all requirements are met and can be traced to its appropriate test case.
  • Environment: Manual Testing, Remedy SIR (Defect Tracking tool), TOAD, Windows XP Pro, .Net, Oracle 10g

QA Analyst

IBM -T. J Watson Research Center
Hawthorne, NY
11.2007 - 05.2008
  • Worked on the project called Smart Surveillance Solution. The IBM Smart Surveillance Solution provides an open and extensible analytic framework for developing event-based video surveillance application for security purpose. All Smart Surveillance Solution functionality is web-based, allowing virtually “anytime, anywhere” access to both real time and historical event data from the system.
  • The IBM Smart Surveillance Solution has many applications across multiple industries, such as retail loss prevention and business intelligence, manufacturing inspection and safety applications, facility monitoring.
  • Creating Test Scripts manually following Functional Specifications.
  • Responsible for each new build installation.
  • Responsible for writing and executing test scripts for each new build and validate the results for each build.
  • Attend Defect review meeting everyday with development team
  • Attend status meetings with vendors on a weekly basis.
  • Review test scripts and approve.
  • Create traceability matrix for each new build
  • Responsible for regression test case execution.
  • Environment: Manual 100%, Windows XP, BUGZILAA Defect tracking tool, front-end Java, Backend Oracle 11i.

QA Lead

KPMG
Woodcliff Lake, NJ
03.2007 - 09.2007
  • Working on the project called Vector. Vector 2007 is an Audit ‘tool’ that utilizes and integrates the functionality of multiple applications including Groove, Work paper Generator, Case Ware Working Papers, KAM, My Knowledge Tool, IDEA (CAATs), and KCA. The Work paper Generator will implement the basic Vector 2007 functionality in Groove’s decentralized collaboration platform. Such functionalities include, but are not limited to the following:
  • General workflows/reports
  • Synchronization
  • Online/offline capabilities
  • Conversion
  • Security
  • Information sharing
  • Worked as floating QA Lead for Vendors’ testing department, and managed QA labor, charting and tracking team milestones, writing test plans, editing manuals, and designing project flowcharts. I have served as liaison between developers and QA/production.
  • Responsible for taking images of the PCs for each new build and installation.
  • Responsible for running test scripts on each new build using QTP and validate the results for each build.
  • Attend Defect review meeting everyday with development team
  • Attend status meetings with vendors on a weekly basis.
  • Review test scripts and approve.
  • Update Clear Quest daily.
  • Create traceability matrix for each new build
  • Time estimations
  • Environment: Manual 75%/Automation Testing 25%, Windows XP, Windows PE, TabletPC edition, SharePoint, Clear Quest (Defect tracking tool), .Net

Senior Validation and QC Specialist

Medidata Solutions
New York, NY
07.2006 - 02.2007
  • Medidata’s Rave (Web based system) Is an Industry- Leading systems for capturing, managing and reporting clinical research data, designed to help life science companies optimize their research investments by efficiently streamlining the clinical trial process It is an Application designed by a single platform supporting both electronic data capture (EDC) and clinical data management systems (CDMS) functionality with an open Architecture it integrates well with the existing Applications including the Industry Standards such as CDIS (Clinical data Interchange Standards Consortium) and Interfaces with other offerings in data Capturing, Safety, data management and Statistical Analysis
  • Worked on the following clients Projects: PFIZER, Boston Scientific, AMGEN, PROPHARMA
  • Creating Test Plans manually
  • Responsible for Creating, validating, and executing manual test scripts to include Functional Test, Boundary Test, Exception Test, Regression Test, UAT, Migration Test and Installation Test.
  • Creating Test Summary Report
  • Recording and tracking software faults
  • Verifying test results and working with Development in resolving software defects.
  • Reviewing, updating and approve project deliverable documents such as Validation Plans, Validation Reports, SOPs etc. to ensure the compliance of security requirements, disaster recovery, GCP and WW Regulatory - requirements.
  • Review SOP and help making changes as needed.
  • Coordinating, Review and compilation of audit response documents for Internal - Regulatory QA Audits.
  • Co-ordinate with client’s issues, attend meetings to review their requirements and help development group to write and review the specifications.
  • Verifying the functionality with reference to User Requirements and Design Specification - for different modules such as Clinical Trail Data, Patient Manager, SAE Reports, and Query Responses etc.
  • Reviewed Validation plans and reports to ensure that the provisions of SOPs that are based on the GLP are followed in respect of Storage and Retrieval of Records and Data.
  • Creation Test summary reports for System Testing and User Acceptance Testing.
  • Creation and update of Traceability Matrix to ensure that all requirements are met and can be traced to its appropriate test case.
  • Environment: Manual/Automation Testing, Windows XP, Support Magic, .Net

QA Tester (Consultant)

ADP
Roseland, NJ
02.2006 - 06.2006
  • Working on application called ADP Welcome Center. The ADP Welcome Center is a web-based product used for the setup of new clients.
  • Creating Test Plans manually following Functional Specifications.
  • Responsible for Creating, validating, and executing manual test scripts to include Functional Test, Boundary Test, Exception Test, Regression Test, and UAT.
  • Creating Test Summary Report
  • Recording and tracking software faults
  • Verifying test results and working with Development team in resolving software defects.
  • Coordinating, Review and compilation of audit response documents for Internal - Regulatory QA Audits.
  • Creation and update of Traceability Matrix to ensure that all requirements are met and can be traced to its appropriate test case.
  • Environment: Manual Testing, Windows XP Pro, Java, and SQL

QA Analyst/Validation and QC Specialist

StayInFront
NJ
11.2005 - 02.2006
  • StayInFront is a provider of integrated software applications, technology, and consulting services to the Pharmaceutical, Biotechnology and Medical Device Industries.
  • Worked on the following clients Projects: KING, ENZON, ROCHE
  • Creating Test Plans manually using MQC
  • Involved in client meetings to review business requirements.
  • Involved helping client’s issues and discussions with developments to resolve the problems.
  • Responsible for Creating, validating, and executing manual test scripts to include Functional Test, Boundary Test, Exception Test, Regression Test, UAT, Migration Test and Installation Test.
  • Creating Test Summary Report
  • Recording and tracking software faults
  • Verifying test results and working with Development in resolving software defects.
  • Coordinating, Review and compilation of audit response documents for Internal - Regulatory QA Audits.
  • Verifying the functionality with reference to User Requirements and Design Specification - for different modules such as Clinical Trail Data, Patient Manager, SAE Reports, and Query Responses etc.
  • Creation Test summary reports for System Testing and User Acceptance Testing.
  • Creation and update of Traceability Matrix to ensure that all requirements are met and can be traced to its appropriate test case.
  • Environment: Manual Testing, Windows XP/2000, MQC 8.0, Java, SQL

Validation and QC Specialist

Medidata Solutions
New York, NY
01.2005 - 11.2005
  • Medidata’s Rave (Web based system) Is an Industry- Leading systems for capturing, managing and reporting clinical research data, designed to help life science companies optimize their research investments by efficiently streamlining the clinical trial process It is an Application designed by a single platform supporting both electronic data capture (EDC) and clinical data management systems (CDMS) functionality with an open Architecture it integrates well with the existing Applications including the Industry Standards such as CDIS (Clinical data Interchange Standards Consortium) and Interfaces with other offerings in data Capturing, Safety, data management and Statistical Analysis
  • Worked on the following clients Projects: PFIZER, Boston Scientific, AMGEN, PROPHARMA
  • Building of Test Plan and Test Strategy.
  • Knowledge of the regulatory operations environment including company requirements and technology developments
  • Identification of testing risks and application risks.
  • Possess Strategic mindset with strong planning, analytical, negotiation, decision-making and process improvement skills
  • Preparation of test scenarios, test cases.
  • Test Data Preparation.
  • Involved in Functional, Regression Testing
  • Maintains defects and deviations using the Defect Management tool Bugzilla
  • Excellent verbal, written and interpersonal skills and experience in working effectively in cross-functional teams.
  • Environment: Manual Testing, Windows XP/2000, MQC 8.0, Java, SQL

Software Test Engineer

eResearch Technology Inc.
Bridgewater, NJ
06.2000 - 12.2004
  • EResearch Technology is a provider of integrated software applications, technology, and consulting services to the Pharmaceutical, Biotechnology and Medical Device Industries. Worked on web based applications called eData Management, EXPERT eDC (eData Capture), eSafetyNet.
  • Test Defects and Test Summary Reports for new releases and software patches according to the FDA rules and strategies for maximizing data quality, ensuring system and data security and integrity, as well as avoiding compliance pitfalls.
  • Responsible for taking part in the “Whole Product” committee ensuring eResearchTechnology Development Life Cycle and Standard Operating Procedures followed.
  • Responsible for verifying and testing clinical report documents.
  • Responsible for creating, maintaining and document testing documents for new version and software patches including Test Plan, Test Case Specification, Test Log, Test Incidents/Fault Reports, Software Release Form, and Installation Validation Kit.
  • Responsible for Creating, validating, and executing manual/Automated test scripts to include Functional Test, Boundary Test, Exception Test, Regression Test, Migration Test and Installation Test.
  • Responsible for Verifying test results and works with Development in resolving Software defects
  • Responsible for attending internal Client Audits.
  • Environment: Manual Testing (75%), WinRunner 7.5 (25%), Quality Center (Test Director) 8.0. Windows NT, Windows 2000/2003, Windows XP and Oracle 9i, Visual Basic 5.0

QA Tester

XENON INFOTEK Engineering &Consulting Inc.
NJ
12.1999 - 04.2000
  • Note: More information can be provide as needed on above companies.

QA Tester

CITIBANK CORPORATION
NEW YORK
03.1998 - 10.1999
  • Note: More information can be provide as needed on above companies.

QA Tester

ITM Inc.
NJ
02.1996 - 02.1998
  • Note: More information can be provide as needed on above companies.

Education

BS Degree -

Gujarat University
India

Skills

  • Test Tools: Robot, Win Runner 75, QTP, Quality Center (Test Director), JIRA, Soap UI, Postman, Mobile Center, Sprinter, ALM, SharePoint, Jira
  • Languages: C, C, Visual Basic v 50, PLSQL, XML, HTML, JAVA, J2EE
  • Databases: Oracle 73, Oracle 10G, MS Access, Sybase, and SQL
  • Browsers: Netscape, Internet Explorer, Google Chrome, Firefox
  • Operating Systems: Windows NT/98, Windows 95-XP, Windows 10,UNIX, MS DOS
  • Certification: ITIL Foundation Certified

Timeline

Business Quality Manager (Contractor)

AstraZeneca Pharmaceuticals
06.2021 - 03.2026

BA/Validation Test Lead/PM (Contractor)

EISAI Pharmaceuticals
05.2019 - 06.2021

BA/ UAT Test Lead

GAF: Building Materials Corporation
07.2013 - 12.2018

BA/ UAT Test Lead

The Hertz Corporation
03.2011 - 07.2013

QA Lead

Theknot Inc
03.2009 - 03.2011

Test Coordinator- Tester

Boston Scientific
07.2008 - 02.2009

QA Analyst

IBM -T. J Watson Research Center
11.2007 - 05.2008

QA Lead

KPMG
03.2007 - 09.2007

Senior Validation and QC Specialist

Medidata Solutions
07.2006 - 02.2007

QA Tester (Consultant)

ADP
02.2006 - 06.2006

QA Analyst/Validation and QC Specialist

StayInFront
11.2005 - 02.2006

Validation and QC Specialist

Medidata Solutions
01.2005 - 11.2005

Software Test Engineer

eResearch Technology Inc.
06.2000 - 12.2004

QA Tester

XENON INFOTEK Engineering &Consulting Inc.
12.1999 - 04.2000

QA Tester

CITIBANK CORPORATION
03.1998 - 10.1999

QA Tester

ITM Inc.
02.1996 - 02.1998

BS Degree -

Gujarat University

Status

US Citizen
Sonal Jani