SUMMARY

• Having Over all 7+ years of experience as a Business Analyst in Pharma Industries.
• Extensive knowledge of SDLC with different methodologies, such as Waterfall, Scrum, RUP, Extreme Programming and Scrum - Waterfall Hybrid.
• Proficient in authoring Business Requirement Document (BRD) and deriving Functional Requirement Document (FRD).
• Experience with the implementation and post production support of LIMS-Empower interface.
• Strong knowledge in FDA regulations, GxP suites (GAMP4 & GAMP5, GDP), Computer System (CSV) & Equipment Validation, Documentum, LIMS and Track wise.
• Experienced in reviewing all SDLC documents, protocols and SOPs to ensure they meet GxP and FDA regulations.
• Experience in managing and participating in configuration and design of Labware LIMS and various lab applications for the Genetic Quality.
• Experience in Creating business cases, followed GxP, 21 CFR part 11 regulations providing deliverables to the pharmaceutical.
• Strong understanding of GxP quality guidelines on Good Manufacturing Practice, Good Laboratory Practice (GLP).
• Strong Knowledge in FDA 21 CFR Part 11, 210, 211, 820 and ISO 13485 for medical and pharmaceutical industries.
• Experience in coordinating with R&D, clinical trials, manufacturing, regulatory affairs and know the process of NDA application.
• Experienced and professional employee with knowledge in regulatory compliance, GMP, Quality Assurance Audits, Document control, Quality Assurance/Quality Control activities in the pharmaceutical.
• Experienced in working on Clinical Care Management web application system enhancement by conducting thorough analysis on the app usability.
• Strong knowledge of FDA QS 21 CFR 820, 211 for Pharmaceutical, Life Science, GMP, GCP, GLP, CAPA, GRP, EMR, EHR & QMS.
• Strong Knowledge in developing new business initiatives, business analysis, strategy development, regulatory approvals for marketing, newMarketAccess to international business partners.
• Experienced in Clinical, EMR, EHR, PACS, HR, Pharmacy and Interfaces.
• Experience in using of UFT, Test Complete, Conformiq automation tool to prepare Test Framework utility Functions and Generic Functions (Object Repository/Name Mapping, Synchronization, Actions, Parameterization and Recovery Scenarios etc.,)
• Instrumental in clarifying business requirements, experienced in performing Gap Analysis, Impact Analysis, Risk Analysis, Traceability Matrices, SWOT Analysis, and Cost Benefit Analysis.
• Experience withProjectManagement, in the areas ofProjectPlanning includingProjectestimations (cost, dates, resources) using MSProject(MPP).
• Proficient at creating and transforming business requirements into software requirement specification (SRS) using Rational RequisitePro and designing business models using UML diagrams such as use case model, Class Diagrams, Activity Diagrams, Sequence Diagrams and Collaboration Diagrams in Rational Rose and MS Visio.
• Good understanding of Agile (Scrum) software development lifecycle include sprint planning meeting and sprint backlog, scrum meetings, daily stand up and Retrospective.
• Deep experience with the design and development of Tableau visualization solutions.
• Experience with various elicitation techniques and JAD sessions for requirement gathering.
• Experience in Using JIRA for User Story requirements management throughout the Agile Sprints and development life cycle
• Experience in business process modelling, requirements gathering, As-Is and To-Be Analysis, Fit-Gap analysis and feasibility study and Impact Analysis.
• Experience of working closely with testing teams for identifying Test Scenarios also writing and executing Test cases.
• Expertise in organizing and managing UAT sessions like planning, training and validating results.
• Actively involved Postproduction support and conducting end user training sessions.
• In-depth knowledge of Rational Unified Process (RUP) risk engineering data modelling and mapping and design using UML, Rational Rose, Visio, and other related tools.

PROFESSIONAL EXPERIENCE

Confidential, Woodcliff Lake,NJ

Sr. Business Analyst

Responsibilities:

• Worked on gatheringbusinessrequirements by interviewing the Subject matter experts (SMEs), conducting JAD sessions with stakeholders and documented them in a format that could be reviewed and understood by both businessand technical teams.
• Performed as a business and technical analyst by translating user requirements into practical / integrated process-based solution.
• Meeting with subject matter experts to identify and document all functional requirements for LIMS, MES and Oracle EBS.
• Worked with the team Involved in the computer system validation (CSV) lifecycle, which matches with FDA regulations particularly 21 CFR part 11 and validation requirements like reporting features, password regulatory rules, password aging and session time-out for the LIMS system.
• Started working onPharmaand Operation report grouping and identified what are thegenericareas each group
• Worked on Labware LIMS v7 and Emerson Syncade (MES) Integration and Oracle EBS project.
• Provide support for Manufacturing/ Quality Systems like Laboratory Information Management System (LIMS) and Open Array Manufacturing Order Processor.
• Attended trainings such as EDC-Rave, Oracle Argus Suite and Electronic Document Management Systems (EDM), Change Management and Control, Validation with respect to a specific project.
• Configured laboratory information management systems, such as Lab Vantage SQL LIMS, developing validation master plans and validating LIMS implementations.
• Business analysis consulting with business partners to identify, define prioritize business systems and functionalrequirements forPharma RevenueManagementsolution.
• Provide core Revenue Management reports necessary for everyday work of Revenue Management team using SQL.
• Conducted JAD sessions, created Use Cases, workflows, screen shots and Power Point presentations for the Web Applications and maintained product quality under GMP requirements.
• Created business cases, followed GxP, 21 CFR part 11 regulations providing deliverables to the pharmaceutical.
• Represented department in cross-functional teams, projects, and GXP-related problem resolution.
• Review of promotional materials as per the Label specifications compliance with GxP GLP, GCP, GMP and GDP FDA Compliance Regulations.
• Coordinated with R&D, clinical trials, manufacturing, regulatory affairs and know the process of NDA application.
• Wrote BRD, FRD, use cases, test scenarios, test cases for testing the functional requirement.
• Worked on implementation of CRM, CLM, and Contracting modules forMarketAccessTeam.
• Created and reviewed Validation Deliverables for Data Integration between Clinical Trial Management System (CTMS) and Drug Shipment Tracker and between TrialTrak and Electronic Data Capture (EDC).
• Created a Requirements Traceability Matrix (RTM) kept a track of product backlog, sprint backlog, and time estimates using agile tools like Jira.
• Managed Electronic Document Management System (EDMS) for automating R&D and Regulatory document repositories for submissions to the FDA.
• Involved in data migration from the existing system Cerner (Internal Application for Account Receivable and Coding) to new system IMS (Intelligent Medical Software).
• Manufacturing Practices (GMP) and Good Clinical Practices (GCP).
• Participated in continuous improvement projects for a Medical andPharmaceuticalDelivery Contract Manufacturing Organization.
• Responsible for reviewing and approving glass syringe product transfer activities from R&D to Commercial Operations.
• Reported the overall progress periodically to the Project Management andbusinessstakeholders.
• Worked extensively with the QA team for designing Test Plan and Test Cases for the User Acceptance Testing.
• Reviewed Stored Procedures for reports and wrote test queries against the source system (SQL Server) to match the results with the actual report against the Data mart (Oracle).
• Involved in Analyzing and successfully completed the full product development life cycle of a high visibility, high throughput screening Laboratory Information Management System (LIMS).
• Utilized corporation developed Agile SDLC methodology. Used Scrum Work Pro and Microsoft Office software to perform required job functions.
• XML is used extensively to communicate with web service component and to populate data at the client side.
• Involved in mentoring specific projects in application of the new SDLC based on the Agile Unified Process, especially from the project management, requirements and architecture perspectives.
• Created RUP activity diagrams and sequence diagrams to analyse the requirements and recommend solutions.
• Assisted the technical team in translating application functionality into application architecture.
• Clarified QA team issues and reviewed test plans and test scripts developed by QA team to make sure that all requirements will be covered in scripts and tested properly.
• Conducted User Acceptance Testing (UAT), gathered and documented User Manuals and Business Rules.

Confidential, Corona, CA

Business Analyst

Responsibilities:

• Interfaced with the client as part of the Requirements Engineering team to finalize the project scope.
• Conducted user interviews, gathered Requirements, analysed the Requirements and managed changes using Rational Suite.
• Managed the project documentation using the Confluence document management system during the entire project cycle.
• Conducted JAD sessions with business users and Subject matter expert and stakeholders to define project scope, to identify the business workflows & task analysis and determine whether any current or proposed systems are impacted by the new development efforts.
• Involved with the team managing the planning and requirements phase for the implementation of a Laboratory Information Management System (LIMS).
• Involved in Writing and reviewing Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) protocols for theLIMSapplication.
• Participate in the analysis of the User Requirements and Functional Requirements for Agile PLM andLIMS.
• Involved in design and development of Clinical Trials Management System (CTMS) integrated with EMR and customized to suit protocols following CDISC, GCP and other FDA standards.
• Worked on Documentum for Version Controlling, to maintain up to date changes in the Documents.
• Supervised training and directing a group of highly skilled IT professionals operating R&D and Corporate GxP.
• Involved in Assured Process Validation, Cleaning Validation, and Software Validation in compliance with GXP (GMP, GLP).
• Involved in developing and reviewing Computer System Validation deliverables in compliance with FDA 21CFR Part11, CFR Part 210 and GxP GLP, GCP, GMP Compliance Regulations.
• Worked with Documentum Enterprise content management (EDMS) using pharmaceutical GxP standards to capture, store, preserve and deliver content and documents related to organizational processes with Every Document Now Available (EDNA).
• Well-versed in documentation of Business Requirements Documentation (BRD), Functional Specifications Documentation (FSD), Current-State and Future-State Process Models, Performance Indicators.
• Created Process Flow diagrams, Use Case Diagrams, Class Diagrams and Interaction Diagrams using Microsoft Visio and Rational Rose.
• Managed and prioritized user stories using JIRA. Worked with the development team to identify blockers and provide resolution.
• Administration of Clinical R&D software including Oracle clinical, Clinapps PMD, Forecasting and sales and marketing software Spotfire and Cognos.
• Prepared the Validation Summary Report (VSR) summarizing the validation activities that were performed for theLIMSapplication.
• Involved in mentoring specific projects in application of the new SDLC based on the Agile Unified Process, especially from the project management, requirements and architecture perspectives.
• Maintained and enhanced Next Gen Electronic Medical Records (EMR), Electronic Practice Management (EPM), and Imaging Control System (ICS) software.
• Used JIRA for User Story requirements management throughout the Agile Sprints and development life cycle.
• Assisted with user testing of systems, developing and maintaining quality procedures, and ensuring that appropriate documentation is in place.
• Used SQL to test various reports and ETL load jobs in development, QA and production environment.
• Performed User Acceptance testing & End to End testing in interaction with Offshore QA/Dev teams for various system releases & pushed them to production.
• Data mapping, logical data modelling, created class diagrams and ER diagrams and used SQL queries to filter data within the Oracle database.
• Responsible for writing the Test Cases and Test Scenarios based on the Functional Specification and technical Specification and documented in Mercury Quality Centre.

Confidential, South San Francisco, CA

Business Analyst

Responsibilities:

• Demonstrate detailed understanding of the department and a broad knowledge of other areas of the business.
• Reconcile incoming Chargebacks submissions based on frequency of distributor submission schedule (Daily, Weekly, and Monthly) and process resubmissions.
• Responsible for gathering, analyzing, documenting and validating requirements for the development of a Laboratory Information Management System (LIMS) for clinical laboratory processes within the Hospital.
• Worked as a BusinessAnalystfor ETL projects that extract data from various source systems for subject areas - Revenue, Billed Membership, Medical Claims, Pharmacy Claims, and Capitation.
• Involved with the IT team to develop software for interpretation of LIMS Data.
• Assist with tracking, analyzing and reportingRevenueManagementcontact centre and agent performance statistics.
• Working on clinical trials/drug safety systems in Global Pharmacovigilance group to manage the study, data activity, analysis, financial, reports, product, market/sales on Argus Safety DB, and reporting tools.
• Involved in mentoring specific projects in application of the new SDLC based on the Agile Unified Process, especially from theprojectmanagement, requirements and architecture perspectives.
• Strong capability within the organization to enable Automation from Test Design to execution by using the innovative concept of using Conformiq.
• Used JIRA for User Story requirements management throughout the Agile Sprints and development life cycle.
• Prepared, processed and filed clinical documentation and reports. Provided recommendations on LabwareLIMSprocesses while focusing on industry best practices and commercial off the shelf functionality.
• Worked very closely with business and other important stakeholders (MarketAccess Policy/COE leaders) in understanding current business process flows and future capabilities.
• Create Business Process Flow diagrams using Swim lanes in Microsoft Visio.
• Created new orders in the Laboratory Inventory Management System (LIMS) & Electronic Medical Records (EMR).
• Executed Test Cases in System, Integration, Backend, Front-end, Regression, E2E, and UAT using SQL queries and UI testing on applications.
• Created business cases, followed GxP, 21 CFR part 11 regulations providing deliverables to the pharmaceutical.
• Interpret and apply FDA regulations as they pertain to GxP computer systems, lab equipment and process validations GxP.
• Worked with UAT testing team to setup data, share test cases, and provided results walkthroughs.
• Well versed in Business Process Modelling with expertise in creating User Cases, Sequence Diagrams, Class Diagrams, Activity Diagrams, writing User Stories.
• Provide leadership to other team members and transfer knowledge across departments, Operating Companies, etc.
• Redesigned the JIRA workflow and schemas in late 2016 in order to produce a more agile framework and standardization. Migrated over 50 projects to the new workflow while producing buy in from IT Leadership.
• Created documents of the use cases and created the use case, activity, logical, component and deployment diagrams using MS Visio and Rational Rose, Data warehouse to communicate clearly with the development teams.
• Involved in creating Business Requirements Gathering sessions in the form of questionnaires and business scenarios with the end users, subject matter experts (SME) and the developers. Gathered user and business requirements through interviews, surveys and prototyping.
• Demonstrated skills in critically conducting the GAP Analysis throughout the projects in evaluating/ analyzing the existing standards and policies to determine the improvements.
• Authored functional requirements based on the needs of users. Authored a governance plan detailing the rules and policies for the SharePoint Project.
• Redesigned web services methodology for the application while implementing reusability from different servers. Liaised with the technology team to derive Functional Requirements.
• Serve as a liaison between software development and other internal teams, including product management, quality assurance and client services to ensure successful implementation.
• Integrated Confluence-JIRA Spring 2017. Application owner for JIRA and Confluence.
• Played a pivotal role in conducting Functional testing, Regression testing, Integration testing, Smoke testing and UAT (User Acceptance Testing).

Confidential - Rahway, NJ

Business Analyst

Responsibilities:

• Involved in Conducting JAD sessions for communicating with the all Project Managers and stakeholders.
• Worked as an Interface between the users and the different teams involved in the system development.
• Involved in Assisted patients in minimizing medical expenses by recommendinggenericalternative prescription medications.
• Followed agile methodology, being Business Analyst as Product Owner for better Collaboration among Scrum Master, Scrum Team and Business Stakeholders.
• Involved in Mapping of data for the early-stage development clinical trials study through an application named Trial Setup.
• Carried out GAP analysis to prepare As-Is and To-Be state of the system/application post feature implementation by preparing business process flow diagrams.
• Involved in UML standards like Use case diagrams, Activity and Swim lane diagrams using MS Visio and Lucid Chart. Conducted Prototype demos, wireframes and walk through sessions.
• Involved in writing Use Cases to precisely document the flow and function of specific UI and system features.
• Prepared business requirements document (BRD) for the analysed feature and conducted.
• Used the Office Suits extensively which included MS Word, MS excel, MS Access, MS Visio also Smart sheet for various documentation and analysis reports.
• Involved in assigning, monitoring, and coordinating the workload to the team members as a lead software tester/validation engineer in the testing, validation and support efforts of MES (WERUM's PAS-X) and Labware LIMS applications in FDA Controlled environment.
• Coordinated in design phase Data Mapping with team for FSD and worked on CDM, LDM& PDM.
• Involved in organizing UAT, activities like strategy, Planning, Designing and Training sessions.
• Worked closely with QA team for identify and prepared Test case scenarios, Test Cases and test data based on business process.
• Report defects in test management tool and manage them throughout their lifecycle using JIRA.
• Involved in mentoring specific projects in application of the new SDLC based on the Agile Unified Process, especially from the project management, requirements and architecture perspectives.
• Involved in creating RUP activity diagrams and sequence diagrams to analyse the requirements and recommend solutions.