Summary
Overview
Work History
Education
Skills
Websites
Certification
Software Quality Assurance Experience
Timeline
Generic

Shradha S

Summary

10 years of experience as a quality assurance tester with CRISC certification and Automation with TOSCA. Have worked on Pharmaceutical Compliant application and Web testing e-commerce website. Conducted Change Advisory Board meeting and analyzed risk for user and business requirements. Overseen Validation Deliverables for the LIMS application and completed the Validation process to stay in compliant meet regulatory needs. Focused with 8 years of expertise in regulatory compliance, audit procedures, project oversight and risk management. Excellent history of delivering effective leadership and training to support staff development. Driven and strategic with an aptitude for program management. Knowledge of agile methodologies SDLC process and Scrum Methodology. Highly-motivated employee with desire to take on new challenges. Strong work ethic, adaptability, and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.

Overview

11
11
years of professional experience
1
1
Certification

Work History

Validation and Compliance

Eurofins Lancaster Labs
08.2022 - Current
  • Work with off shore team and sprint teams to executed and created in TOSCA
  • Provide appropriate knowledge transfer of FDA compliance and check test cases and evidence align to meet regulatory needs
  • Support the implementation and management of strategic initiatives to support global QA Testing activities including standards, strategies, and roadmaps
  • Responsible for authoring the Standard Operating Procedures (SOP), Requirement document and Release Document based on company policies in accordance with GxP standards
  • Responsible for managing all project related risks are well managed and deliverables are validated
  • Worked closely with the labsites across for assisting during client and FDA audits to ensure all required compliance is met
  • Act as liaison between business, analysts, development teams and test team on operational topics
  • Help Scrum Master in the absence to co-ordinate release and deployment
  • Helped the automation team to align test cases per business logics and provided feedback
  • Worked with release and coordinated with support and business QA for timely release document and approval
  • Validate test cases and recreate using the Risk Based approach
  • Working with a team to convert the current manual and automation test cases into TOSCA.

QA Test Lead

EurofinsITSolutionsIndia
Bangalore
03.2020 - 08.2021
  • Work with off shore team and sprint teams to executed and created in TOSCA
  • Work with offshore team to transform current test cases to TOSCA automation
  • Check Business requirement and compliance for the test cases
  • Provide appropriate knowledge transfer of FDA compliance and check test cases and evidence align to meet regulatory needs
  • Support the implementation and management of strategic initiatives to support global QA Testing activities including standards, strategies, and roadmaps
  • Responsible for authoring the Standard Operating Procedures (SOP), Requirement document and Release Document based on company policies in accordance with GxP standards
  • Responsible for managing all project related risks are well managed and deliverables are validated
  • Worked closely with the labsites across for assisting during client and FDA audits to ensure all required compliance is met
  • Act as liaison between business, analysts, development teams and test team on operational topics
  • Help Scrum Master in the absence to co-ordinate release and deployment
  • Helped the automation team to align test cases per business logics and provided feedback
  • Worked with release and coordinated with support and business QA for timely release document and approval.
  • Generated and published reports detailing results of process, product and department audits and inspections, describing corrective actions required.
  • Performed manual and automated testing of software applications to ensure quality assurance standards were met.
  • Analyzed existing systems documentation to determine appropriate tests needed for each project phase.
  • Studied processes and systems using quality tools to analyze production costs, identified non-value-added activities and made process improvement recommendations.
  • Monitored and facilitated bug resolutions to optimize software.
  • Wrote and updated manual test cases for team use, maintaining optimal organization for maximum productivity.
  • Tested functionality, performance and compliance of each product against design specifications to maintain strong development standards and high customer satisfaction.
  • Documented, triaged and managed defects in MTM TFS Azure Dev Ops and worked with developers to facilitate timely resolutions.

Software Quality Specialist

Eurofins Lancaster labs
PA
06.2015 - 10.2019
  • Created and developed Test Scenario, Test cases for e-LIMS application in MTM (Microsoft Test Management) and tested to ensure data flow correctly using SQL scripts
  • Established key deliverables of Computer system Validation, User Requirement Specification (UR) Functional Requirement specification, Validation Plans, Request for Change document 21 CFR part 11 and EU Annex 11 Requirements and GxP Risk impact assessment
  • Apply a structured methodology and lead the Change Advisory Board meeting to prioritize the requirements while working collaboratively with the project manager and process owners
  • Performed risk management activities using Failure Mode Effect Analysis (FMEA) and GAMP method techniques to identify potential failure modes on pharmaceutical to ensure Risk Based Testing
  • Provide audit reports and evidence to ensure the system is compliant with GxP standards
  • Worked in Agile/ Scrum Methodology and ensured to complete the committed stories by the end of the sprints
  • Worked closely with Business Analyst and actively participated in grooming stories for sprint commitment
  • Pointed stories based on complexity using Hatjitsu Online Scrum Panning for Agile Projects
  • Analyzed bugs and reported to the Developer and co-ordinated to fix to meet business requirement
  • Created UAT test cases and Executed them, helped the end users understand and use the application
  • Estimated effort required to perform QA activities and reported QA status on Daily basis
  • Created Functional Definition tracing to User Requirement Traceability business functionality coverage
  • Creating User Acceptance Test Case (UAT) for users before production
  • Worked with off shore team to implement different modules of the application to ensure all functionality is working as expected by the business
  • Worked closely with the business to ensure requirements are linked and is traceable for audit and process documentation
  • Represented business User Requirements and provided support with appropriate and robust solution for user needs
  • Worked with software development team to ensure computer system validation deliverables are completed and appropriate procedures are in accordance with business GxP requirements
  • Worked with Capability Maturity Model Integration (CMMI) to guide process improvement across Software Quality Team
  • Reviewed requirements and design documents with developers and project manager to confirm expected functionality with technical and business needs
  • Evaluated features using risk based testing techniques
  • Gathered Business Required Document and created Test plan and Test cases
  • Designed, formulated and optimized application test strategy, test scenarios, and test cases
  • Tested multiple types of Publisher & subscription model interfaces ex Web service to Database, Database to Database, FTP to Database etc
  • Validated data integrity in the source and the target systems for Bug free Data transmission
  • Performed Positive, Negative, load and Regression tests for given CRs [Change Requests]
  • Arranged weekly meetings with responsible source and target system leads for test plan review and status
  • Communicated project readiness, status and potential risks with stakeholders
  • Documented quantified and elevated risks and provided statistical reporting and analysis
  • Estimated effort required to perform QA activities and reported QA status on Daily basis
  • Managed to work independently or as a Team player in dynamic work environment
  • Quickly adapted to multiple external systems and applications to validate the dataflow among systems
  • Tested SOAP over HTTP and Rest Services using Soap UI
  • Performed load tests and Data Validation on External services
  • Performed security Tests on internal and External Web Services.

QA Lead, Quality Assurance

QVC, Inc. (Contract)
01.2014 - 06.2015
  • Was the first QA to start on the business team and have trained and managed a group of 6 people In the team
  • Estimate and manage testing deliverables and efforts in support of business Vertical
  • Review requirements and specifications
  • Have recommended process and Tools for QA
  • To develop and review test plans and scripts using Quality Center
  • Responsible for the launching of the QVC.com website on IBM WebSphere's platform
  • Regression testing of the QVC website
  • Documented Test scripts in Jira
  • Executed Test scripts using Jira.

Quality Analyst

The Doctor’s Co
Napa, CA
01.2013 - 12.2013
  • Created and developed Test Scenario, Test cases for Billing Accounts, Process Payments, Cancel policies and Refunds for different user lines for multiple states
  • Worked In Agile development environment and implemented Agile (Scrum) QA methodologies
  • Performed Function Testing, Integration Testing and Conversion Testing on the vista system
  • Created Test Plan, Test Cases, Test Coverage Document and Reported Test Metrics
  • Developed, modified and executed test cases for Integration testing
  • Executed Black Box Testing, Positive Testing, Negative Testing, Integration Testing, ETL Testing, Functional Testing, System Testing, Regression Testing, Stress Testing, User Acceptance Testing (UAT)
  • Performed Concurrency testing for premium accounting modules
  • Functionality testing on Lockbox process, Process batch cash and Process suspense functionality
  • Developed automated test scripts for CR (Change Request) for vista and Claims legacy system
  • Expert in Creating procedures in PL/SQL, packages, functions, database triggers and other database objects like Lob's to generate back-end and front-end report
  • Exclusively developed packages with extensive use of SQL query Joining tables SQL functions , PL/SQL with the use of cursors , REF Cursors and Loops
  • Use of Sequences to automate number generation in SQL
  • Developed complex SQL queries including Sub queries, correlated queries, and Nested queries, Unions, Intersect and Aliases
  • Extensive used SQL functions like DATEPART, TO_CHAR, SUBSTRING, EXTRACT, NVL, TRIM and many more to generate data for testing
  • Involved in testing Web services(SOAP and REST) and XML with tool called SOAP UI for the local WSDL / with URL and created Test cases, run them, do load testing, security testing
  • Responsible for Setting up Web Services project using WSDL in SOAPUI and provided setup help to other team members
  • Developed and automated Data driven testing of services to verify and assert request-response messages against a large set of data in SOAP UI
  • Performed Load test to measure performance along with ensuring that the functionality is not breaking by applying different load test strategies in SOAP UI
  • Performed data validation for the migrated data sets from legacy system to LIMS system
  • Tested invoices/payments for standard accounts and custom with ERC and Non-ERC accounts
  • Performed testing on Refunds, Financial Transactions and A/R History by Policy, A/R History by Billing account, A/R History by Unit functionality
  • Tested role-based security which allows/restricts access to system features and data based on roles assigned to a user
  • Extensively tested flat rate, prorate and short rate cancellation procedures
  • Performed test cases on Process Batch Cash, IPN, and ERC, Refunds reports that were developed using Business Objects
  • Extensively tested DocuCorp XML interfaces and tested policy documents, billing document
  • Tested the Refund Security, Payment Plans, Primary Billing modules for existing and new policies.

Education

Master’s in computer science -

West Chester University

Bachelor’s in chemistry -

Calcutta University

Skills

  • Risk Management
  • Reporting Requirements
  • Internal Audits
  • Risk Management Strategies
  • Risk Mitigation
  • Team Management
  • Familiar With SQL, Python
  • Programming
  • Documentation Management
  • Testing Tools (eJIRA, MTM - TFS Azure, Quality Center)
  • Selenium , TOSCA Automation Tool
  • Test Case Management

Certification

  • ISACA CRISC Certified, 221843824
  • Certified Scrum Master, 1320461
  • ISPE GAMP 5 & Part 11 training Course Completed
  • Certified in TOSCA Tricentis Automation Specialist Level 1
  • Certified in TOSCA Tricentis Automation Specialist Level 2
  • Certified in TOSCA Tricentis Test Design Specialist Level 1
  • Certified in TOSCA Tricentis Automation Specialist for API

Software Quality Assurance Experience

Functional Testing, System Testing, Regression Testing, User Acceptance Testing (UAT), GUI Testing, Web testing, Microsoft Test Management, HP/Mercury Interactive Testing Tools, eJIRA, TOSCA, Quality Center/Test Director, SQL, UNIX Shell scripting, JavaScript, Python, Selenium, TOSCA, Tableau, SOAP UI, Postman, Fiddler, Spec flow, Jira, Quality Center, Microsoft Test Management, GIT Hub, Big Bucket, Agile-Scrum, Waterfall, Kanban, My SQL, Oracle DB, SQL, ETL, PostgreSQL

Timeline

Validation and Compliance

Eurofins Lancaster Labs
08.2022 - Current

QA Test Lead

EurofinsITSolutionsIndia
03.2020 - 08.2021

Software Quality Specialist

Eurofins Lancaster labs
06.2015 - 10.2019

QA Lead, Quality Assurance

QVC, Inc. (Contract)
01.2014 - 06.2015

Quality Analyst

The Doctor’s Co
01.2013 - 12.2013

Master’s in computer science -

West Chester University

Bachelor’s in chemistry -

Calcutta University

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Shradha S