Ten years of diverse experience in Business Analysis, Validation, Quality Assurance, Validation, Document Management System, LIMS, Experience includes project successes in the areas of requirement gathering, documentation, UML diagrams, Market analysis, Project Management, vendor software implementation, business intelligence, and quality assurance and testing. Possess strong analytical, design, development, validation, documentation, maintenance, issue- resolution and change control procedural expertise in the Information Technology, Health Care and Pharmaceutical industries.
Career summary:

• Computer software system validation experience in compliance with FDA standards referred 21 CFR Part 11, Electronic Records/ Electronic Signatures.
• Authored and implemented various standard operating procedures (SOPs)
• Managed Requirements Gathering through JAD sessions, Storyboard sessions, interviews and workshops with clients, developers, and QA Analysts.
• Evaluated and deployed different vendor solutions including COTS and SaaS solutions.
• Ran JAD sessions periodically withstake holders, end-users, subject matter experts, Project Managers, QA teams and Development Teams.
• Created andorganized deliverables utilizing various reporting and requirement management tools i.e, Business Analysis Documentation, Business Requirement Documentation (BRD), Functional Requirement Document (FRD),Project/ Product Definition Document (PDD), System Requirement Specification (SRS), andChange Management Documentation (CMD).
• Evaluated AS IS process and developed TO BE model.
• Created, edited and managed process improvements and process reengineering documentation.
• Utilizing Visio, Blueworkslive, and MS Excel, created many data flow diagrams and flow charts.
• Implemented industry best practices.
• Well versed in dealing with Relational Database Management Services using Oracle, MS SQL Server, DB2 and MS Access.
• Expert with industry standard methodologies like Agile, SCRUM, XP, Rational Unified Process (RUP), Waterfall and industry specific Hybrid models.
• Developed detailed market analysis reports for upper management for market measurement on weekly, monthly, and ad hoc basis.
• Developed and maintained the Requirements Traceability Matrix (RTM).
• Performed CSV Risk Assessment.
• Extensively worked with various vendors in the Main Frame environment.
• Performed Data analysis and wrote data migration plan.
• Performed GAP and cost-benefit analysis as required.
• Developed Installation, Operational and Performance Qualification (IQ, OQ and PQ) Validation Protocols.
• Worked extensively with application programmers to develop proposed solution prototypes.
• Wrote use cases and Developed Test Plans and created Test Cases.
• Obtained expertise in performing System, Acceptance, Regression, Integration and Functionality Testing.
• Generated many customized reports using various tools like Cognos.

CERTIFICATIONS:

• FDA- 21cfr, Code of federal regulations part 11-electronic records and electronic signatures
• Good manufacturing practices (GMP)
• Good Laboratories Practices (GLP)
• Good Clinical Practices (GCP)
• Requirement Analysis
• Requirements gathering & authoring user and functional specs
• Test planning and Test management
• Defect investigation and reporting

Summary of the Technical Skills

Operating System:Windows 2000/XP/Vista, UNIX RDBMS:Mainframe, DB2, MS SQL Server, Oracle, and MS-AccessTesting Suite:Mercury Quality Center, QTP, Load Runner and Rational SuiteWeb Tools:MS Visio, Rational Rose, Rational Requisite Pro, Rational Clear Case, Rational Clear Quest, and DOORSProject Management:MS Project, Team Track, MS Excel, MS office Suite, MS SharePoint, ISO, CMMIProgramming Languages:HTML, XML, Java, SQL, JavaScript, Visual Basic, SAS, C, and C++Other Tools/applications:Blueworkslive, eRoom, Documentum, Filenet, Content Management, Rational Rose, Test Manager, UML, ETL, SPSS, EDMS, Facets, Cobit, CAPA, QMS, QSR, ISO, Track wise, LIMS, SAP, ICIS, Xybion, and reporting tools etc.

Sr. Business Analyst/System Analyst Washington, DC 12/11- present
Confidential 
Responsibilities:

• Involved in interaction with Clients, Business Analysts and IS leaders to make overall IT policies better based on the industry standards.
• Created process improvement.
• Developed process reengineering master plan.
• Developed IT Governance policies.
• Used Filenet as content management tool.
• Developed over all IT policies based on the industry standards and best practices.
• Analyzed system and document audits.
• Performed GAP Analysis.
• Worked on Risk assessment.
• Developed Traceability Matrix (RTM) to track all the work flows and policies.

Sr. Business Analyst/Project Manager Washington, DC 06/10- 09/11
Confidential 
Responsibilities:

• Involved in interaction with Clients, Business Analysts and Benefits Leads for better performance of unemployment benefit distribution life cycle.
• Developed process and business reengineering documentation based on system requirement.
• Used EDI Gateway and EDI standards extensively to exchange data
• Imported data or converted codes into application open interface tables so that application program interfaces (API) can validate and update Oracle application tables for inbound transactions
• Wrote documentation for all aspects of the unemployment benefits life cycle.
• Evaluated different vendor solutions (including COTS and SaaS solutions).
• Developed test protocols, scenarios, and scripts to test business critical applications QAS.
• Worked heavily on Main Frame.
• Wrote integration master plan.
• Qualified the protocols regularly.
• Developed migration plan.
• Analyzed user and Functional requirements.
• Used agile development methodology extensively.
• Performed UAT prior to deployment of QAS software.
• Worked on deployment and implementation of automatic unemployment benefit process.
• Met with project team to point out deficiencies in requirements and ways to improve them
• Developed Requirements Traceability Matrix (RTM) to track requirements during the QA Testing Phase.

Confidential, WV Apr’09 – Mar’10
Sr. Business Analyst/System Analyst 
Responsibilities

• Designed the business requirement collection approach based on the project scope and SDLC methodology.
• Studied existing business application and processes, collected end user requirements and suggested the improvised business process model.
• Developed process and business reengineering master plan.
• Used Filenet as contentment tool.
• Worked on Claims, Customer services, Members, Billing-Enrolment interfaces and extensions for FACETS as a part of FACETS implementation team.
• Worked on Facet implementation team and involved in process modeling, prepared Business Process Models that includes modeling of all the activities of the business from the conceptual to procedural level.
• Involved in gathering business requirements and collaborated on creation of documents such as the Vision, business requirements (BR) and business with systems design (BSD) documents.
• Worked on 837 institution and professional, 834, EDI Gateway and EDI standards ANSI ASC X12N Health Care Claim (837).
• Analyzed data architecture, documented and delivered data mapping, and performed risk analysis.
• Analyzed and documented the System specifications, Business requirements and detail design of the software for full understanding of the business and used Requisite Pro for the requirement tracking and analyzing.
• Experienced consumer driven health carethat allow members to use personal Health Savings Accounts (HSAs), Health Reimbursement Arrangements (HRAs).
• Managed traceability matrix to trace Business Requirements, Functional requirements and System test scripts using requisite pro, clear case and clear quest.
• Used Rational Rose to model the process using the Unified Modeling Language (UML) to create use case diagrams, activity diagrams, sequence diagrams and collaboration diagrams.
• Worked with CEO, VP Operations, VP Marketing and subject matter experts (SME) to develop business strategy, mission and guiding principles.
• Developed timelines for project delivery, and managed projects and resources to successful completion.

Confidential WI Oct’07 – Feb’09
Sr. Business/QC Analyst II

• Involved in interaction with Clients, Business user and Validation Leads for better performance of Validation life cycle.
• Managed detail project plans which includes; resources planning, tasks planning, budgeting, milestones set-up, and performed GAP Analysis, Impact Analysis, Cost Benefit Analysis & Risk Analysis.
• Worked across international team while gathering and documenting requirements.
• Led the requirement gathering process and facilitated international meeting.
• Evaluated and deployed different vendor solutions (including COTS and SaaS solutions).
• Used agile development methodology extensively.
• Ran JAD sessions periodically withStake Holders, End-users, SMEs, ProjectManagers,QA team and Development Team.Drafted SOPs, IQ/OQ/PQs for creating validation documents.
• Worked on Facets functionality, data model and the data hierarchy.
• Developed requirements including planning and prioritization, resource and issue management, change control, version management and test data management.
• Developed business and process reengineering master plan.
• Created andorganized deliverables in a secure retrievable area: such as BAD (Business Analysis Document), BRD(Business Requirement Document),FRD (Functional Requirement Document),SRS(System Requirement Specification) andChange Management Documents.
• Wrote many use cases.
• Used automated testing tools like Rational Suite and RUP.
• Analyzed and implemented Business Process Analysis and Design (AS-IS and TO-BE).
• Analyzed Test Scripts to verify complete functionality, which needed to be in compliance with 21CFR Part 11 enforced by the FDA.
• Wrote and validated IQ/OQ/PQ and SOP documents for all analytical instruments and associated tests.
• Generated reports using Tox-reporting.
• Acted as the SME for the business domain and conducted the knowledge transfer with the testing and development teams.
• Assured Process Validation and Software Validation in compliance with cGXP’s (cGMP, GLP, GCP, GMP).
• Assisted the development and testing teams during the execution phase with functional expertise as required.
• Used Filenet extensively as contentment tool.
• Assisted the implementation team in conducting the User Acceptance Testing of the developed solution.
• Developed Requirements Traceability Matrix (RTM) to track requirements.

• Facilitated JAD sessionswith Stake Holders, End-users, SME’s, Project Manager, QA team and Development Team.
• Ensured and implemented GxP (GCP, GLP, and GMP) environment.
• Responsible entire business and functional analysis.
• Developed business and process reengineering plan along with the SMEs.
• Conducted frequent meeting with project team to point out deficiencies in requirements and ways to cover it.
• Developed Installation, Operational and Performance Qualification (IQ, OQ and PQ) Validation Protocols.
• Worked on DOORS.
• Generated various customized reports using Tox-reporting.
• Facilitated the development of multiple solution options to address the business needs.
• Wrote Use Cases and developedUnified Modeling Language (UML) and Data flowdiagrams (DFD) for process mapping in RUP methodology.
• Developed test protocols, scenarios, and scripts to test business critical applications.
• Wrote Validation/Testing master plan.
• Created templates and wrote all sorts of documents, SOPs, Memos etc and converted them into PDF and Archive them in EDMS.
• Worked on Documentum and used it for Version Control.
• Analyzed Test Scripts to verify complete functionality, which needed to be in compliance with 21CFR Part 11 enforced by the FDA.
• Developed Requirements Traceability Matrix (RTM) to track requirements.

Confidential PA June’06 – Dec’06
Business Analyst/ Validation Specialist

• Reviewed the User Requirements Document, Blue Print Summaries and prepared the Detailed Test Plan and Test Criteria.
• Analyzed User and Functional Requirements.
• Developed process reengineering document.
• Participated in analysis and design of the proposed solutions.
• Wrote documentation for all aspects of the computer systems validation lifecycle, in accordance with FDA regulations, particularly CFR 21, part 11, including: Validation Plan and Protocol, Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ).
• Coordinated with System Analyst and Project Manager to setup the pre-validation and Validation environment to execute the scripts.
• Assisted the development and testing teams during the execution phase with functional expertise as required.
• Maintained the Requirements Traceability Matrix (RTM) to track requirements.

• Wrote documentation for all aspects of the mortgage cycle.
• Evaluated different vendor solutions (including COTS and SaaS solutions).
• Wrote integration master plan.
• Wrote functional specification.
• Developed process reengineering document.
• Qualified the protocols regularly.
• Developed migration plan.
• Analyzed user and Functional requirements.
• Used agile development methodology extensively.
• Performed UAT prior to deployment of the new software.
• Worked on deployment and implementation of automatic loan process.
• Met with project team to point out deficiencies in requirements and ways to improve them.
• Trained all employees into new market and capital trends.
• Educated employees in Risk Measurement including market analysis.
• Maintained risk assessment to pre-qualify the mortgage applications.
• Did many regression analysis and empirical studies using SAS and SPSS.

• Master of Science in Communications Technology
• Master of Arts in Applied Economics