Manjunath K Email & Phone Number

India

Product Owner - US Healthcare- Commercial Specialty Business Division ( AI / ML based )

Program BA - Product Management - DigitalGovernment Business Division - Medicaid

Product Management - Digital

Prepare Questionnaires and support in Client Workshops as part of Requirement Gathering sessions.Perform assessment of testing organization to determine its current maturity level (AS-IS analysis)Perform gap analysis and define the operating model for the testing organization (TO-BE analysis)Develop recommendations for process improvements for clients and create high level roadmaps for implementationDefine framework, guidelines, templates, user manuals, checklists, etc. to establish a Testing Center of Excellence (TCoE)Responsible for validation of Business Requirement Document (BRD), Functional Requirement Specification (FRS), User Requirement Specification (URS) and Requirement Traceability Matrix (RTM).Create Project planning, track progress & milestones and report on deviationsPerform Computer System Validation of Gxp Systems that include - Validate Test Cases, Test Reports pre and post Test execution, make recommendations for changes and/or improvements.Maintain all documentation (Test Cases, Test Reports, Requirements Traceability Matrix) pertaining to computer systems validation in HP- Application Lifecycle Management (ALM).As part of 21 Code of Federal Regulations (21 CFR Part 11), 21 CFR Part 820 - Quality System Regulations, validated Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) documents.Good understanding of Drug development lifecycle.Experienced in performing Periodic Reviews; Good understanding of GXPs and its requirements. Good understanding of global regulations and Health Authorities, Medical Devices Regulatory expectations governing computerized systems.Experienced in supporting CSV Audits / Regulatory Inspections.Forecasting of resources and analyzing the project costs on an ongoing basis to prepare a high level financial status report used for management reviewTraining new joiners to team by giving functional and technical knowledge related to the project.

Bangalore

o Played a Data Engineer - Consultant role which is a key role in analysing business requirements, designing and implementing the Solutions to cater the business requirements of Cliento Responsible for designing and maintaining requirements through System Requirement Specification, Operational Level Agreements, Service Level Agreements and Service Delivery and Definition Expectations as a part of Requirements Engineeringo Liaise between development team, technical analysts, and Product Management Team to ensure optimal operational performance of the Producto Track and document the changes for functional and business specificationso Construct workflow charts and Process diagrams in the BI/DW area for Product Developmento Hand hold with Development and QA team during requirement executiono Contribute in Risk Assessment plans, Approve plans, protocols and support documentationo Ensure defect tracking, reporting and making sure to get resolved on time working with Multiple Service Providerso Responsible to work with Client and Business heads to get approvals/Sign-Offs for the Go-Live implementation of the new releases of Application/Producto Create test process library and streamlined testing artefacts.o Mentor /Advise team members in Process activities