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Kamesh - Business analyst

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Location: , , USA

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Kameshwara Rao Sriadibhatla [email protected] Sr BUSINESS SYSTEM ANALYST Senior Business Analyst and Project Manager with 13+ years of experience across diverse business domains, specializing in requirements gathering and business process improvement for the CRM and Enterprise Platforms. Skilled in stakeholder management, waterfall and Agile project delivery, and cross-functional collaboration across functional and technical teams. Proficient in creating BRDs, FSDs, user stories, process flows, and use cases, with strong experience in gap analysis, UAT coordination, and change management. Proven ability to manage multiple initiatives, align business needs with technical solutions, and support data-driven decision-making through analysis and reporting. Experienced in analyzing, managing, and documenting business requirements across complex software development projects (SDLC), collaborating with cross-functional teams to deliver solutions aligned with business objectives and regulatory compliance standards. Expert in eliciting, documenting, and analyzing business requirements, including creating Business Requirements Documents (BRD), Functional Specifications (FSD/FRD), and Requirement Traceability Matrices (RTM). Facilitated requirement-gathering workshops, including Joint Application Development (JAD) sessions, stakeholder interviews, and focus groups, while maintaining Stakeholder Analysis Matrix and RACI Matrix to define stakeholder responsibilities and project impact. Deep domain expertise in pharma across sales, quality management, R&D, and manufacturing, with a strong understanding of regulated environments, audit readiness, and compliance-driven system design Delivered CRM, ERP, DMS, QMS,PPM, LIMS and other enterprise softwares for regulated domains. Conducted Gap Analysis and Impact Analysis, identifying business process gaps using As-Is & To-Be Process Documents, Process Flow Diagrams (PFDs), Business Process Model and Notation (BPMN), and Value Stream Mapping (VSM) to recommend feasible process improvements. Performed stakeholder mapping and analysis, managing effective communication across business, technical, and management stakeholders. Acted as the liaison between business stakeholders and technical teams, translating complex business requirements into clear technical specifications. Served as a primary liaison with regulatory authorities, effectively communicating regulatory requirements and project deliverables to internal stakeholders. Participated in SDLC planning by contributing to the Software Development Plan (SDP), Release Notes, Deployment Plans, Feasibility Studies, and Business Case Documents. Conducted Root Cause Analysis (RCA) to identify pain points and recommend process optimizations. Experienced in business process re-engineering (BPR) to optimize workflows and eliminate inefficiencies. Documented, analyzed, and tracked change requests (CRs) using Change Request Forms (CRF), Impact Analysis Reports, Change Log, Configuration Management Plan and updated Requirement Traceability Matrices (RTM) to ensure seamless integration into BRD and FSD while maintaining Version Control for traceability. Collaborated with stakeholders through Change Control Board (CCB) meetings, assessing scope changes, documenting impact findings, and ensuring alignment with business objectives while mitigating risks and minimizing disruptions. Conducted risk analysis and impact assessments, supporting informed decision-making and proactively managing business risks. Experienced in Scrum, Kanban, and SAFe Agile frameworks, ensuring smooth software development cycles. Defined user stories, acceptance criteria, and managed product backlogs in Agile methodologies, facilitating backlog grooming sessions with Product Owners and Scrum Teams. Experienced in SAFe (Scaled Agile Framework), working closely with Product Owners, Agile Release Trains (ARTs), and cross-functional teams to define business requirements, manage product backlogs, and ensure alignment with PI objectives. Participated actively in process improvement initiatives, driving efficiency, reducing redundancies, and optimizing workflows. Demonstrated proficiency in handling multiple projects concurrently, ensuring timely delivery, quality outcomes, and stakeholder satisfaction. Mentored junior analysts and team members, enhancing their analytical skills, business understanding, and technical competencies. Managed User Acceptance Testing (UAT) processes, developed test cases, created Test Plan, coordinated test execution, logged defects in Defect Log, and compiled Test Summary Reports to ensure project readiness. Conducted End-to-End (E2E) testing using Test Scripts and Requirement Traceability Matrix (RTM) to validate system integrations and ensure all functional requirements were met. Worked on automated testing tools such as Postman (API testing), and JMeter (performance testing). Ensured data accuracy and validation for migration projects, verifying data integrity during transitions. Used data profiling and cleansing techniques to maintain quality standards. Collaborated with UX/UI teams to validate wireframes, mock-ups, and prototypes, ensuring alignment with stakeholder expectations and project requirements. Ensured thorough documentation maintenance, including repositories like SharePoint, with updated version control and accessibility. Proficient in MS Project, JIRA, Confluence, Salesforce, and Office 365 tools such as Excel, PowerPoint, and SharePoint, ensuring seamless project tracking, reporting, and cross-functional collaboration. Contributed to project roadmap development, executive reporting, and budget/CBA analysis for technology initiatives to support data-driven decision making. Experienced in defining business requirements for API-driven integrations, collaborating closely with technical and business stakeholders while maintaining API Documentation and Data Mapping Specifications for RESTful APIs, SOAP-based web services, and microservices architecture. Defined API requirements, including data mapping, endpoint validation, JSON/XML payload definitions, API versioning, and efficient information exchange across multiple applications and cloud-based platforms. Used SQL for querying, data extraction, and reporting, supporting data-driven decision-making. Analyzed complex datasets using advanced SQL queries, stored procedures, and functions to inform business decisions and identify trends Used reporting and visualization tools such as Tableau, Power BI, and Excel Dashboards to develop dashboards, Regulatory Reporting Templates and business reports for senior management. Business Skills Requirements Gathering, Stakeholder Management, Business Process Analysis, Risk Assessment, Compliance Analysis, Regulatory Reporting, Data Analysis, Impact Assessment, Gap Analysis, Change Management, UAT Coordination, Workflow Optimization, Financial Modelling, Dashboarding, Documentation, Cybersecurity Frameworks, API Integration, Identity Access Management, Cloud Security, Incident Response, Reporting Automation, Business Process Reengineering, System Integration, Data Governance, Risk Mitigation, Process Mapping, Business Intelligence, ERP Systems PM Methodologies Waterfall, Agile, SDLC: Waterfall, Scrum, Iterative, SAFe, Hybrid Systems Salesforce, Zoho, Document Management, Change Management, Dealer Management, Program Management, CAPEX Disbursement. Project Management Tools MS Project, JIRA, Confluence, SharePoint, MS Office Suite (MS Excel, Word, PowerPoint, MS Teams Data Analysis, Visualisation, BI and Reporting Tools PowerBI, Tableau, MS Excel, Power Automate Compliance & Regulatory Standards FDA 21 CFR 11, GxP, GDPR, EU Annex 11 Databases mySQL, Microsoft SQL Server, PostgreSQL. Requirement, Test and Defect Management JIRA, Confluence, Postman, Swagger. Cloud Technologies AWS, Microsoft Azure Cloudely Inc April 2025 Present Santa Clara, California Senior Business Analyst/Project Manager Project 1: Regulatory Document Management System for Pharmaceutical Industry Konfeeg Pharma Document Management System (K-PDMS) is designed for regulated industries, especially pharmaceuticals and life sciences, to digitally manage, control, and govern documents across their entire lifecycle. The system replaces paper-based processes with a centralized, automated, and compliance-ready platform, ensuring audit readiness, data integrity, and operational efficiency. Roles and Responsibilities: Gained a deep understanding of project requirements, scope, and objectives by collaborating with key stakeholders from Quality Assurance, Quality Control, Manufacturing, others and IT teams to ensure alignment with business goals, regulatory mandates, and technical feasibility. Facilitated comprehensive requirement elicitation workshops and Joint Application Development (JAD) sessions with Quality Assurance, Quality Control, Manufacturing, others and IT teams, clearly documenting business, regulatory, and technical requirements in Business Requirements Documents (BRD) & Functional Specifications (FSD/FRD). Conducted detailed gap and impact analysis between current-state Document workflows and future-state integrations, clearly identifying 21 CFR 11 compliance gaps and operational improvement opportunities. Acted as a primary liaison with senior stakeholders and regulatory compliance teams, ensuring continuous alignment of project deliverables with compliance requirements and regulatory expectations. Managed multiple project priorities concurrently, balancing requirements across regulatory compliance, quality systems, manufacturing operations, and validation-driven system implementations. Developed and maintained detailed project artifacts and documentation within central knowledge repositories in Jira and Google Docs, ensuring compliance-related documentation was readily accessible for audits and regulatory reviews. Performed regulatory impact assessments to ensure alignment with evolving industry standards, internal policies, and applicable compliance guidelines. Collaborated with business, risk, and IT teams to define and implement standardized processes and identity verification workflows, ensuring alignment with enterprise compliance and operational requirements. Delivered structured training and demos to business users and stakeholders through engaging PowerPoint presentations, facilitating the smooth adoption of new systems and processes. Prepared detailed stakeholder reports and dashboards using Power BI, effectively summarizing project status, data-driven insights, and key performance indicators for senior business and technical stakeholders. Used JIRA and MS Project to track project progress, manage risks, and document project artifacts. Provided post-implementation support and audit readiness, ensuring seamless handover of compliance frameworks to risk management teams. Environment: Hybrid SDLC, Agile Methodologies, REST APIs, SQL Databases, Power BI, Confluence, SharePoint, MS PowerPoint, MS Word, MS Excel Microsoft Teams Infionic Inc OCT2022 Mar2025 India/USA Senior Business Analyst/Project Manager, Client Services Project 1: Document Management System Client: Hetero Labs, Azista Pharma, ZIM Laboratories DMS is designed for regulated industries, especially pharmaceuticals and life sciences, to digitally manage, control, and govern documents across their entire lifecycle. The system replaces paper-based processes with a centralized, automated, and compliance-ready platform, ensuring audit readiness, data integrity, and operational efficiency. DMS provides a robust, compliant, and scalable solution for managing regulated documents. By combining lifecycle management, workflow automation, security, and compliance controls, it enables pharmaceutical organizations to streamline operations while maintaining the highest regulatory standards of 21 CFR 11, GxP. Project 2: Quality Management System Client: PI Industries, Novatris Delivered an end-to-end Quality Management System to digitize change request intake, impact/risk assessment, approvals, and closure with full traceability from initiation to implementation. Enabled audit-ready reporting and controlled workflows, improving change cycle time by ~25% and reducing post-release issues through standardized reviews. Project 3: Dealer Management System Client: GC Dental Global The Dealer Management System (DMS) designed to centralize dealer onboarding, order management, and service workflows, providing end-to-end visibility across sales, logistics, and finance operations. The platform enabled scalable dealer engagement, improved operational transparency, and data-driven decision-making across multi-region dealer networks. Project 4: Laboratory Information Management System Client: Appco Pharma Delivered a STARLIMS LIMS implementation to support compliant sample management, test execution, and result reporting in alignment with GxP and audit requirements. Defined functional workflows, validations, and user access controls to ensure data integrity and traceability. Enabled inspection readiness through standardized processes and electronic records. Project 5: Capital Expenditure Disbursement System Client: PI Industries Delivered a Capital Expenditure Disbursement System to automate CAPEX request intake, multi-level approvals, funding release, and payment tracking with end-to-end audit trails and role-based controls. Improved spend visibility and governance by reducing disbursement/approval cycle time, strengthening compliance reporting, and minimizing post-production exceptions through structured hypercare and change control. Project 6: Program Management System Client: PI Industries Delivered an end-to-end Program Management System overhaul to replace a legacy platform with standardized KPI tracking, executive dashboards, and centralized portfolio reporting. Led go-live readiness and hypercare stabilization, improving onboarding time by 30% and increasing reporting accuracy through controlled UAT, governance, and post-production incident management. Project 7: PSSR (Pre-Startup Safety Review) Software System Client: PI Industrie Led the delivery of a PSSR (Pre-Startup Safety Review) Software System for the EHS organization of a large chemical manufacturing facility, translating regulatory and operational requirements into a structured, compliant digital workflow. Enabled controlled initiation, role-based approvals, checklist execution, and audit-ready documentation, ensuring safe and compliant startup and restart of equipment and processes. Roles and Responsibilities: Elicited and documented business, functional, and regulatory requirements through stakeholder interviews, workshops, and cross-functional collaboration across quality, manufacturing, engineering, and enterprise systems.. Managed stakeholder expectations and competing priorities by planning and prioritizing compliance deliverables, maintaining requirements traceability matrices (RTM), resolving requirement gaps, and clearly communicating project timelines, validation milestones, and regulatory commitments. Performed detailed gap analyses and regulatory impact assessments, documenting compliance requirements and ensuring alignment with GxP, FDA 21 CFR Part 11, EU Annex 11, and internal quality standards. Acted as a liaison between business stakeholders, IT teams, quality, validation, and regulatory groups, translating regulatory and operational requirements into clear business and functional specifications to ensure cross-functional alignment. Created process flow, system architecture, and data flow diagrams to visualize manufacturing system integrations, controlled access, and data integrity across validated on-premise and cloud environments. Participated in risk assessments and impact analysis sessions to identify system dependencies, assess compliance risks, and define mitigation strategies within ERP, DMS, and quality systems. Collaborated with system architects and administrators to configure role-based access controls, audit trails, and system monitoring, ensuring data integrity, traceability, and inspection readiness. Optimized slow-running SQL queries, reducing report generation time by 40% and improving overall database performance Designed and executed UAT and validation plans, including test scenarios and acceptance criteria, to validate system functionality, data integrity, and regulatory compliance across integrated platforms. Performed post-implementation validation and periodic compliance reviews, assessing system performance against regulatory and quality requirements, and documented continuous improvement recommendations to support ongoing compliance. Led compliance and validation documentation using Confluence and reporting tools, creating audit-ready repositories and dashboards to track compliance status, validation progress, and operational readiness. Maintained controlled, traceable documentation repositories for requirements, validation artifacts, test evidence, SOPs, and audit records to support governance, inspections, and knowledge transfer Conducted data analysis and reporting using Excel and translated insights into clear executive-level presentations, enabling informed decision-making by senior quality, operations, and program stakeholders. Environment: Hybrid SDLC(Agile/ Waterfall), Azure Cloud, ERP System, Tableau, Microsoft Project, SQL, Confluence, MS PowerPoint, MS Word, MS Excel, GxP, FDA 21 CFR Part 11, EU Annex 11 My Enterprise Biz Automation Jan2009-Oct2022 Hyderabad, India Associate Business Analyst - Asst Manager(CRM Implementation) - Business Analysis Project 1: Marketing Cloud Implementation Client: Nikon MEA Delivered a Salesforce Marketing Cloud based solution for Nikon MEA, modernizing the digital engagement platform for recognized professional photographers. Implemented an integrated Experience Cloud solution to streamline the selection, approval, disbursement, and tracking of promotional and loaned equipment, improving governance, visibility, and operational efficiency across regional marketing and operations teams. Project 2: Support/ Service Cloud Implementation Client: Multi Commodity Stock Exchange of India. Delivered a Service Cloud go-live to modernize enterprise support operations, implementing segmented, multi-tier SLA frameworks, automated case routing, and standardized escalation workflows for high-volume support teams. Led end-to-end UAT, cutover planning, and post-go-live hypercare, improving first-response time, stabilizing operations, and ensuring a controlled launch with traceable requirements and minimal production defects. Project 3: ERP System for U.S. Medicinal Marijuana Client: TheraCann International. Delivered a regulated Seed-to-Sale ERP platform for TheraCann International, supporting end-to-end cultivation, manufacturing, and retail operations with state-compliant traceability, audit-ready audit trails, and controlled, validated workflows. Led go-live readiness, cutover, and hypercare stabilization, improving release success and post-launch reliability while strengthening regulatory compliance, operational transparency, and end-to-end visibility.. Project 4: Sales Management System. Client: Mauritius Commercial Bank. Delivered a Sales Management System for Mauritius Commercial Bank, streamlining the end-to-end sales lifecycle and KYC-enabled customer onboarding through compliant, standardized workflows, customer profiling, and SLA-driven service activation. Led go-live readiness and post-production stabilization, achieving faster onboarding, improved auditability, and seamless integration with core banking and downstream operational systems. Project 5: Support Management System. Client: Tata Business Support Services. Implemented a sales/service management system for TBSS to standardize case handling, routing, escalations, and SLA governance across support operations. Supported go-live readiness and hypercare stabilization, improving operational efficiency and reducing rework through traceable requirements, controlled UAT, and post-production incident management. Roles and Responsibilities: Collaborated with senior business and IT stakeholders to capture CRM business and system requirements, supporting roadmap planning, feature prioritization, and release readiness. Authored and maintained CRM requirements documentation (BRDs, functional specifications, data mappings), ensuring traceability, version control, and alignment across CRM lifecycle phases. Conducted gap and impact analyses to assess enhancements, integrations, and data migration impacts within CRM platforms and connected enterprise systems. Created CRM process flows, data flows, and system interaction diagrams using MS Visio to clarify lead, account, case, and transaction workflows and support cross-team alignment Extracted and manipulated large volumes of raw data from the data warehouse to create customized reports and visualizations in Tableau Partnered closely with CRM developers and system analysts to ensure accurate implementation of business rules, automation logic, and data validation within the CRM platform. Assisted CRM change management and stakeholder communications, clearly articulating new workflows, feature changes, and user impacts to drive adoption. Supported CRM UAT activities, including test case creation, execution support, defect tracking, and validation against defined acceptance criteria. Participated in post-release reviews, gathering user feedback, validating CRM outputs, and identifying opportunities for continuous platform and process improvement Managed multiple CRM workstreams and priorities simultaneously, maintaining clear status reporting, timelines, and deliverable tracking using project and CRM management tools. Assisted in CRM reporting and dashboard development, monitoring transaction efficiency, data quality, adoption metrics, and operational performance using Excel and visualization tools (e.g., Tableau). Collaborated on CRM training materials and user documentation, supporting effective onboarding and adoption across sales, service, and operations teams. Facilitated stakeholder alignment and review sessions, capturing key decisions, follow-ups, and action items using MS PowerPoint for presentations and MS Word for detailed documentation, ensuring transparency and cross-functional communication. Environment: Waterfall SDLC, CRM Systems (Salesforce, Zoho, Sugar, Vtiger) AWS Cloud, MS Office Suite (Excel, PowerPoint, Access), PMO tools, SharePoint, Tableau, MS Visio Certified Scrum Product Owner. Certified Business Analyst. Anaplan level 1 Modelling. IBM Certified Product Manager (Level 1) Bachelor of Engineering, Electronics and Communications | Himalayan University, India Keywords: user interface user experience business intelligence rlang information technology golang green card microsoft mississippi