Seema Rajaram

• Clients: Johnson and Johnson
• Project Name: STUDIO UDI Releases (SingleSource, RDB Dam and Reports)

Digital and AI global Test program Manager Responsibilities:

• Develop and define the overall testing roadmap, budget, strategy, and approach for AI and Digital product releases
• Overseeing the testing and Validation of AI/Digital machine learning models, ensuring accuracy, reliability, compliance, regulatory standards, and validation deliverables
• Coordinate with the regional deployment (Americas, Europe, and Asia) test managers/Leads, and internal development / 3rd Party technical teams globally, across all types of testing initiatives and phases
• Understand and report upon testing status for each testing phase, representing internal development and third-party development and testing progress
• Partner closely with regional testing managers to ensure test execution and phase gates are met (Entry-Exit) between test activities
• Prepare overall weekly Global Test Summary Status Report for all types of testing initiatives and phases
• Gather approvals and provide input for 'Go / No Go' decision for testing and deployment
• Ensure release management and version control maintenance occurs for each testing environment
• Own and distribute communications related to environments / releases
• Ensure that all testing environments are ready and stable, and there are no testing equipment / environment blockers
• Communicate testing information to all stakeholders
• Direct regional testing managers to ensure testing updates are actively managed in Test Management Tools
• Ensure program testing artifacts are developed, reviewed, and approved

Global UAT Manager for UDI - Key Responsibilities: • Manage the End-to-End Testing strategy for the Global UDI Program based on input from various business product directors and application owners (New Device Submission to global HA - FDA/EUDAMED). • Work closely with the Product owners , Design the UDI program administration structure to support defining the stories, risk assessment, manage the E2E UAT testing plan, resource plan, schedule, data readiness, Testing deliverables, Test execution, Defect management and Test Closure. • Working with Global (America, EU, Asia etc.,) Deployment leads, define E2E UAT Testing scope and overall validation test protocol/ plan, strategy, scripts for all operational companies and markets or Health Authorities (HA – FDA, EUDAMED etc.). • Initiate Review and approval workflow to get the computer system assurance (CSA) testing (SIT/UAT/E2E) deliverables such as Test protocols , scripts, Requirement Trace Matrix digitally signed off (Vault, JIRA,HP ALM) by the Business Product and Application owners and Quality Team (TQ/IT QA) • Manage the E2E Dry run unscripted testing and Defect cycles to identify all the system, integration, functional, data (completeness and accuracy based on business mapping rule ), design /configuration, environment ,data analytics, inbound, outbound failures and requirement gaps in advance to the formal testing to avoid unnecessary documentation effort and reduce defect fall rate in UAT/pre prod testing. • Communicate with all the team (Data teams, different application Dev, SIT,UAT) daily to ensure the E2E connection and functionalities are working and stable. • Decision making on Go/No Go to production deployment readiness based on the UAT Test Report(Acceptance criteria defined and actual result). • Host the Daily/weekly meetings/defect triage calls and share the Status reporting to the Leadership team

• Clients: PFIZER
• Project Name: RPS GPC/PDM/PEARL INT/AUTOMATION, WORKDAY INT, RPA PDM BOTS AUTOMATION
• Supervise and hold accountability for the Regulatory Process simplification and Automation Program's multiple complex projects
• Listen actively to the clients' needs, use insights to create workable project schedules
• Generate contingency plans to manage risk and solve problems quickly and efficiently
• Negotiate timelines, specifications, and budgets
• Provide outstanding customer service, using clear communication and building positive relationships with clients
• Maintain detailed and accurate project logs and complete all necessary validation documentation

• Clients: LABCORP
• Project Name: Clinical Application and Dashboard Testing (CTMS)
• Validation of the E2E Clinical trials management system
• Partners with the business, product, and development team, serving as the lead QA resource
• Provides high levels of functionality, usability, and testability expertise during the requirements phase
• Establishes and leverages formal QA process and oversees all aspects of quality assurance

• Clients: GILEAD SCIENCE
• Project Name: OBIA/OBIEE UPGRADE, HYPERION PLANNING ENHANCEMENT
• Verification of the clinical trials, product submission status tracking and financial data reports or dashboards
• Test Data file Preparation/Manipulation by cloning and masking the production data
• Ensure data completeness and correctness

• Clients: IBM, TDBANK
• Project Name: SAP CRM/HCM Testing
• Worked with testing teams to develop comprehensive test/ assurance strategy plans
• Define the strategic direction for software quality assurance
• Perform Project Manual Testing Activities using Microsoft Test Lead

• Clients: MASTERCARD
• Project Name: DEBIT AND CREDIT CARD TRANSACTIONS
• Provided progress reports to all clients and worked with vendors to resolve issues
• Prepared and reviewed SIT test implementations and tracked any defects

• Clients: AETNA
• Project Name: SIT MEMBER ENROLLMENT, PLANNING AND CLAIM SUBMISSION APPLICATION
• Designed and Developed ETL (Extract, Transform, Load) process using Informatica PowerCenter
• Created Data mappings to transform and load data from various sources into target systems