Shreya Bhattacharya
Technical Leader
Experience
Apr 2024 - Present
1 year 10 monthsTechnical Leader
SLK Software
- Participate in quality workshops for requirements gathering and fit/gap analysis
- Demonstrated different QMS modules/processes with focus on customer requirements
- Design and implementation of cloud based quality system reducing manual efforts for the client
- Collaboration with cross functional teams to define and document system requirements
- Understanding the existing business process flow and suggesting improvements over moving to new quality systems
- Managed the implementation of a data migration strategy from legacy system to cloud
- Providing solution walkthrough to the business users
- Involved in integration of quality system with different third party systems
- Preparing weekly status report and presenting the same to business users and project stakeholders
Apr 2023 - Aug 2023
5 monthsTest & Validation Lead
Cognizant Technology Solutions
- Involved in end to end validation activities for critical manufacturing project
- Creation and execution of validation testing plan
- Develop and execute tests for new products/features and continuous improvement initiatives
- Analyze data, summarize and document test results
- Involved in the transition of non risk based testing to risk based testing approach
- Preparation and review of validation plan, test script inventory, execution results inventory and validation report in Polarion
- Involved in maintenance support activities like preparing maintenance plan and report
- Involved in risk assessment and mitigation of risks
- Preparation of weekly status report and presenting the same to business users and stakeholders
May 2022 - Mar 2023
11 monthsProject Lead
Cognizant Technology Solutions
- Plan and lead project with business process owners to translate the IT strategy into business specifications and sign off the requirements with applicable stakeholders
- Facilitate discussions with business owners about project deliverables and scope, develop project plan, hiring of resources, manage budgets and track project deliverables
- Involved in risk assessment and mitigation of risks
- Implementing ETQ change requests and automated business processes (workflow, approval process, process builder, validation rules) for complaints handling and supplier modules
- Providing implementation/solution walkthrough to the business users
- Master data management using Oracle Apps with approved material, supplier and ETQ codes details transferred into ETQ from MDM
- Preparation of weekly status report and presenting the same to business users and stakeholders
- Preparation of technical documents related to ETQ & MDM applications
- Leading the end-to-end transition activity between Cognizant and 3rd party vendor
- Involved in resource planning, effort estimation, preparing the SOW, billing and revenue related activities for the team, managing timesheets and ensuring the team is compliant
Jun 2021 - Apr 2022
11 monthsTeam Lead
Cognizant Technology Solutions
- Worked in deviation management, audits & inspections, supplier quality and complaints & issue escalations modules
- Requirement gathering, project planning & estimation
- Creation and modification of user accounts and roles, configuring changes using Veeva Admin
- Creation of workflows, page layouts, email templates and validation rules to implement the business logic
- Created custom reports for standard objects as well as custom objects to provide detailed overview of data
- Preparation and execution of IQ
- Writing system test scripts and executing the same
- Identifying & tracking of defects
Jun 2020 - May 2021
1 yearTest Lead
Cognizant Technology Solutions
- Participate in requirement gathering, raise clarifications with customer and track them till closure to eliminate any ambiguity on the scope of work assigned
- Define and implement the testing scope, strategy and test stage plans for the project according to the best QA practices
- Responsible for project planning, management, coordination and reporting for all test related activities across all the testing phases (system, integration, end-to-end & acceptance)
- Preparation & review of system test cases for complaint, CAPA and deviation modules
- Ensure the appropriate test environments are in place, prepare and document test data for complex system testing
- Optimizing test cases for validation
- Release & risk analysis, preparation and maintenance of test cycles in JIRA
- Execution of the test cases and identifying bugs
- Preparation of summary report and presenting the same to business users
- Assisting the users during UAT
- RFC effort estimation
Dec 2019 - Mar 2024
4 years 4 monthsSenior Associate
Cognizant Technology Solutions
- Involved in requirements gathering and fit or gap analysis for different business units
- Collaborated with cross functional teams to analyze potential system solutions based on evolving client requirements
- Preparation of technical and functional specification documents and documenting business processes in the workflow diagrams
- Providing solution walkthrough to the business users
- Migrating data from existing QMS systems to Veeva Vault
- Regular engagement with key customer stakeholders to proactively drive the project success
- Estimate and manage the development of new functionalities and enhancements to the existing ones
- UAT assistance
Dec 2019 - May 2020
6 monthsTester
Cognizant Technology Solutions
- Creation of user accounts, roles and groups using TrackWise Web Admin
- Preparation & review of system test cases
- Execution of the test cases
- Assisting users during UAT
- Preparation of training manuals for end users
- Providing a walkthrough to the end users
- One-to-one interaction with business users
Sep 2015 - Dec 2019
4 years 4 monthsApplication Developer Lead
Tata Consultancy Services Ltd
- Application support and maintenance
- Apache Tomcat server monitoring and maintenance
- Design workflow based form using ETQ tool; worked in MDD nonconformance, CAPA, audit, supplier and complaints handling modules
- Customize the forms using Python script as per client need
- Master data management
- Worked on business on-boarding activity for different applications and business units
- Preparation and execution of IQ
- Involved in interface testing
- Implementing change requests
- Resolving incidents and tasks using Service Now
- Writing system test scripts and executing the same
- Assistance to users during UAT
- Development of filters, calculations and creation of reports using Qlik Sense reporting tool
- Mentored trainees and associates and helped them gain project knowledge in ETQ Reliance application
May 2012 - Aug 2015
3 years 4 monthsTester
Tech Mahindra
- Preparation & review of test cases
- Execution of the test cases
- Conducting various domain-related sessions for the complete team
- Discussion with various components for analyzing the root cause of IVVT defects
- One-to-one interaction with the customer
Summary
- 12+ years of IT experience in the areas of Quality Management, Quality Assurance and Testing/Validation for GMP and GCP regulated environments.
- Sound knowledge in ETQ, Veeva QMS, TrackWise, UNIX, SQL, Service Now, SAP QM, Java, HP QC/ HP ALM, JIRA & Confluence.
- Knowledge of core QA systems like CAPA, Deviations, Complaints Handling, Audit and Change Management.
- Hands on experience in Validation, Unit testing, Functional, Interface testing, UAT and Integration testing.
- Performed Black Box, White Box, System Testing, GUI and Regression Testing.
- Experienced in Project Management, product management and Stakeholder Management across cross-functional teams.
- Well versed in Reporting using Qlik Sense and MS Excel.
- Knowledge of FDA regulations, validation and compliance requirements related to quality assurance.
- Strong understanding of business and quality processes of Pharmaceuticals and Medical Devices.
- Extensive knowledge of Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC).
- Excellent knowledge and hands on experience in handling incidents, SLA and problem management scenarios.
- Proven ability to troubleshoot and identify the root cause of issues (RCA).
- Excellent problem solving skills with a strong technical background and good interpersonal skills, accustomed to working in a team and capable of working under pressure.
Skills
- Language: Sql/plsql, Unix, Java, J2ee, Python Scripting
- Database: Oracle 9i/10g
- Utilities/tools: Hpqc/alm, Reliance Etq, Jira, Polarion, Veeva Vault, Trackwise, Service Now, Successfactors, Sap Qm, Eclipse, Hp Qtp, Oracle Sql Developer, Ms Office, Ms Project
- Reporting: Qlik Sense, Excel
Languages
Bengali
AdvancedEnglish
AdvancedHindi
AdvancedGerman
IntermediateEducation
Oct 2007 - Jun 2011
West Bengal University Of Technology
B.Tech in Applied Electronics and Instrumentation · Applied Electronics and Instrumentation · Kolkata, India
Certifications & licenses
AWS Cloud Practitioner
Certified Scrum Master
Veeva Vault White Belt
Need a freelancer? Find your match in seconds.
Try FRATCH GPT More actions
Similar Freelancers
Discover other experts with similar qualifications and experience