Shreya Bhattacharya
Technical Leader
Experience
Technical 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
Test & 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
Project 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
Team 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
Test 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
Senior 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
Tester
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
Application 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
Tester
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
Industries Experience
See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.
Experienced in Information Technology (14 years), Professional Services (4.5 years), Pharmaceutical (1 year), and Manufacturing (0.5 years).
Business Areas Experience
The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.
Experienced in Quality Assurance (14 years), Information Technology (10.5 years), Project Management (6 years), Business Intelligence (4.5 years), and Product Development (0.5 years).
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
Education
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
Profile
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