OBJECTIVE:

Diversified experience in Healthcare/Pharmaceutical/Insurance domains. I possess a great passion to contribute my skills in a competitive milieu. Learnt and contributed immensely in Project planning, complete SDLC (UML/RUP, Agile, and Scrum). Experienced in Web Technologies and client/server architecture, providing a well balanced understanding of business relationships, business requirements, worked for functional and technical solutions and helped the team at all levels until final product release.

SUMMARY:

• Expertise in implementing the agile, Rational Unified Process and Waterfall Methodologies throughout the Software Development Life Cycle of the project.
• Interacted with the Stakeholders, End Users to understand and gather stakeholder requirements and create the Business Requirements Document (BRD) and Functional Requirement Document (FRD) and communicating it to the entire team involved
• Implemented Unified Modeling Language (UML) methodologies to design Use Case Diagrams, Data Flow Diagrams, Activity Diagrams, Sequence Diagram and ER diagrams
• Lead JAD session and requirements review meetings with all functional groups and participate in industry events
• Prepared and executed validation activities for equipment and utilities such as biosafety cabinets, gases, laboratory systems, incubators, stability chambers, freezers and refrigerators for the start - up facility; actively involved in the implementation of the Labware Laboratory Information Management System (LIMS) Project for Pharmica Biotechnology.
• Prepared and executed validation activities for equipment and utilities such as biosafety cabinets, gases, laboratory systems, incubators, stability chambers, freezers and refrigerators for the start-up facility; actively involved in the implementation of the Labware Laboratory
• Experience in validating Laboratory Information Management System (LIMS), Adverse Event Reporting System (AERS), and Chromatography Data System (CDS).
• Experienced in performing Gap Analysis for 21 CFR Part 11 and remediation.
• Configuring and validation Laboratory Information Management System(LIMS)
• Strong knowledge of Software Development Life Cycle (SDLC) Computer System Validation and QA Methodologies.
• Thorough knowledge of GRC regulation and policies
• Extensive experience in reviewing and analyzing functional requirement specifications (FRS) and system requirement specifications (SRS) and writing detailed Test Plans, Test Cases, and Test Scripts.
• Excellent experience in working with FDA regulated environment, GxP (GCP/GLP/GMP) guidelines .
• Strong Working Knowledge of SDLC, GRC 21CFR Part 11 and software FDA validation practices.
• Functional experience in Manual and Automated testing tools including planning, design and implementation of tests and test cases, integration, system and regression testing and test efforts documentation management.
• Extensive experience as a validation analyst involved in all phases of SDLC. Conversant with all aspects of computer systems validation from Requirements to System and User Acceptance Testing and change control.
• Experienced in application 21CFR part 11, GxP and CSV guidelines.
• Good Documentation skills and well versed in all phases of Validated and non validated testing like Test Planning, Test case estimation, Test Strategy, test case scripting and test case tracking.
• Reviewed and analyzed the data design and data flow between various interfaces from Visio documents and Design documents.
• Strong experience writing Test Plans and Test cases using requirements, use cases and design documents.
• Expertise in manual and automated testing tools (Mercury and Rational Suite of Tools).
• Experienced in software Analysis, Requirements Management, Quality Assurance and maintain Traceability.
• Excellent customer relational skills.
• Excellent Team player and capable of working independently, with excellent written-communication and interpersonal skills.
• Excellent interpersonal and customer relational Skills. Proven communication, presentation skills and Leadership Qualities.

TECHNICAL SKILLS:

Methodologies: SDLC, RUP, UML, Agile, Waterfall

Testing Tools: Test Director / Quality Center, QTP, Win Runner Mercury Test Suite and Rational Suite

Change Management Tools: Rational Clear Quest, PVCS, Rational Clear Case Process Modeler

Quality / Statistical Tools: Six Sigma, SPSS

Business Modeling Tools: Rational Rose, MS Project, MS Visio(2007)

Programming Language: C, C++, Visual Basic, .Net, JAVA, SQL, PL\SQL, UNIX XML

Project Management: Microsoft Project, Microsoft Office (2007)

Database / Data warehouse Tools: Oracle 9i/10g, MS SQL Server 2000 DB2, Sybase, Informatica, Erwin, SQL*Loader

Documentation Tools: MS Office, Adobe Acrobat

Web Technologies: CSS, HTML, XSL, XML, ASP, JavaScript MS Front Page and Dream weaver 2004

Requirement Gathering Tools: Requisite Pro

PROFESSIONAL EXPERIENCE:

Confidential, Peapack, NJ

Business Analyst

Responsibilities:

• Clearly understood the client’s business requirements by interacting with stakeholders, Subject Matter Experts
• Created Project Scope and Vision Document for the project.
• Facilitated JAD sessions to gather requirements and drafted minutes of the meeting with Action Items and Parking Lots.
• Created Business Requirement Document from the JAD sessions.
• Participated in creating and documenting GAP analysis.
• Took instructions from the Project Manager and Team leads and helped them in scheduling Project
• Using MS Project to ensure on time delivery.
• Created Use case documents with the help of these documents created use case diagrams and
• Clearly identified the actors and the use cases.
• Guided new business analysts to create screen mockups for some requirements.
• Using Visio drew Activity diagrams to describe the dynamic behavior of the system Assisted Functional lead and the functional team in creating FDD.
• Under the guidance and instructions of test and development teams, assisted them to create TDD to some extent from FDD.
• Handled change request from the client by using the Change Request Form and followed the documented procedure.
• Facilitated weekly team meetings. Also scheduled bi-weekly meetings with clients.
• Created System Retirement Plan, Data Migration Verification, Data Management Report and Final Retirement Report for Electronic Systems such as Calibration Manager, LIMS, Foxboro, CAPA, Chromatography Data System, Manufacturing Data, Management and Series Batch Assignment.
• Develop documentation and deliverables dictated by the System Development Life Cycle (SDLC) and client Integration Life Cycle (IPLC).
• Development and implementation of the Global LabWare LIMS system for Confidential
• Working on the development of the Environmental Monitoring Program in LIMS. Analyze specifications, design logic and write code for customization of the software using LIMS Basic and SQL.
• Conducted highly interactive meetings with project’s stakeholders such as users, QA analysts, and project management team, identifying and resolving issues.
• Involved in walkthroughs and meetings with development team to discuss related issues.
• Jointly worked with Test lead to create Test Plan.
• Worked together with test team to prepare Traceability Matrix.
• Conducted User Acceptance Testing (UAT) along with users and stakeholders and documented the results for same.
• Involved in the project for implementing Best Practices for Business Analysis in the organization and instrumental in the transition plan for Agile Development methodology using SCRUM.
• Actively participated in creating manual, conducted knowledge transfer sessions and
• Handled change request and change management issues.
• Created User Manuals and participated in End User .

Environment: Microsoft® Visual Basic 6.0, ASP,.Net, Citrix Meta Frame™ 1.8 and Citrix™ 1.5, AT&T T1 Internet Service, Oracle10g, Quality Centre 10.0,SQL Server, Visual Source Safe, Unix and IE 6.0,Microsoft office suite 2007,Internet Explorer, Agile Environment.

Confidential, Atlanta, GA

Business Analyst

Responsibilities:

• Facilitated collection of User Requirements and Business Requirements from Business User Group such as to document Business/User/Functional/Technical Requirement Specification using MS Word and MS Visio that provided appropriate scope of work for technical team to develop prototype and overall system.
• Identified system integration requirements, coordinated the collection and verification of business needs to reach the Requirement Analysis (Requirement Validation Specification), Detailed System Design Documentation Milestones.
• Involved in the day-to-day implementation of the Waterfall methodology of application development with its various work flows, artifacts and activities.
• Reviewed and Authored Standard Operating Procedures (SOP) and trained all users on these systems and the implications and impact of 21CFR part 11 compliant data systems on day-to-day functions.
• Implementation and deployment of MES (Manufacturing Execution System) system for Kaiser.
• Collaborated with business partners and clients to define requirements.
• Installed and configured application based on Citrix, IIS technology. Analyzed specifications, designed logic, wrote code and customized software to implement batch records in MES.
• Responsible for authoring/reviewing validation documents and SOPs.
• Involved in Independent verification and validation of requirements (IV and V) to ensure that all the requirements are satisfied and meet the security objectives
• Developed Traceability Matrix using Rational Requisite Pro.
• Design and deployment of MES system to replace paper based or manual systems including weigh & dispense and material tracking in a pharmaceutical environment.
• Gather user requirements in relation to controlling and recording manufacturing activities.
• Assess manufacturing processes and develop/configure Electronic Batch Records (EBR).
• Implement MES solutions and integration with ERP and or/control equipment.
• Documentation and validation of EBRs.
• Handled Change Requests and taken care of Approved Changed Requests from impact analysis to delivery.
• Developed and reviewed test, Validated test cases and business functional scenarios in Quality Center.
• Conducting test team meetings and involved in developing test plan to accomplish the overall objectives for the time period.
• Actively Participated in the Weekly Defect Status meetings, to review and prioritize the defects with in a Functional area.
• Performed detailed analysis of data issues encountered during business acceptance testing.

Environment: Windows XP, MS Office (MS Word, MS Excel, MS PowerPoint, MS Visio ), MS Access, UML, SQL, Requisite Pro, waterfall, Quality center.

Confidential, PA

Business Systems Analyst

Responsibilities:

• Conducted JAD sessions with business units and stakeholders to define project scope, to identify the business flows and determine whether any current or proposed systems are impacted by the new development efforts.
• Created different documentations based on CMMI standard model.
• Responsible for business system analysis of customizing the BPS Risk Management product with involvement through the whole SDLC
• Managing personnel allocation and SDLC process for systems projects enhancements
• Acted as liaison between development team, testing team and Business SMEs to generate and standardize Functional requirements specification documents, Use cases, Vendor Specification documents and Architectural documents. Converted Business requirements into Functional requirements so that designers and developers can understand.
• Also performed the Data Analysis and Data Mapping for different source system including Mainframe system, Data Warehouse and Database to target system, database and application for the Medicare Part D - Prescription Drug claims.
• Employed UML methodology in creating Use Case diagrams, business/process flow diagrams, and Activity/State diagram to assist development and engineering in understanding the requirements.
• Defined Functional Test Cases, documented, Executed test script in Facets system.
• Designed High level design, for New process, integrating with legacy and Facets
• Responsible for integrating with Facets .Designing test scripts for testing of Claims in Development, Integration and production environment.
• Responsible for writing Functional Requirement Specifications (FRS) and User Requirement Specification (URS).
• Responsible for writing detail requirements for the technical team from BRD’s, such as Functional Design, HLD, LLD, Use Cases, Test Plans, Preparation of Test Data.
• Supported the business and the technical team in the product development and delivery process and successfully managed cross- departmental relationships by Coordinating & writing Test cases with the Development & Testing team.
• Wrote PL/SQL statement and stored procedures in Oracle for extracting as well as writing data.
• Assisted development team with design and testing efforts and assisted them on resolving the reported bugs and various technical issues.
• Developed customized SQL reports and queries for management decision-making and operational management.
• Assisted in preparing and executing Test Cases, and reviewed Test Execution Procedure Document (EPD) document prepared based on the Business Requirement Specifications (URS), Functional Requirement Specifications (FRS) to cover overall quality assurance.
• Participated in the team meetings to discuss the issues arising out of testing. Reported weekly and monthly project status updates to project manager and senior management.

Environment: Microsoft Office Share Point 2007, MS Office, SQL Server, Agile, Rational Clear Quest, Rational Clear Case, Rational Requisite Pro, Rational Rose, UML,RUP, MS Excel, MS Word, Microsoft Power Point, Visio.

Confidential, San Diego, CA

Business Analyst

Responsibilities:

• Gathered Business Requirements by interacting with Business users to author Business Requirements Document (BRD) using MS Word.
• Analyze the requirements and converted them to system requirements.
• Facilitated JAD sessions to get more details about requirements.
• Created Use Case Documents based on requirements.
• Developed Activity Diagrams using MS Visio.
• Conducted Meetings periodically with SMEs at various phases of the Software Development Life Cycle (SDLC) to discuss open issues and resolve them.
• Used MS Project to manage schedules, deadlines, and resources collaborate on the project.
• Coordinated with the System Analyst to author System Requirements based on the Business Requirement Documentation.
• Organized Functional Design Documents (FDD) handoff meetings with the Business and technical team, explaining them the requirements, review the Functional Designs and getting a formal signoff .
• As a part of the validation strategy, created Validation Master Plan, validation approach and checklists such as 21 CFR Part 11, maintenance of electronic records etc in order to show compliance with FDA requirements.
• Worked on the team for LabWare LIMS enhancements and Environmental Master Data. Analyzed specifications, designed logic and wrote code for customization of the software, which included configuration in LIMS Basic, Crystal Reports and SQL. Responsible for assigning work to team members, providing weekly status to Project Manager.
• Consultation with other developers to ensure compatibility with other modules and applications as well as with users and stakeholders to ensure that requirements were met.
• Assessed Change Controls and implemented necessary changes in LIMS.
• Development and implementation of the Global LabWare LIMS system for Confidential .
• Working on the development of the Environmental Monitoring Program in LIMS. Analyze specifications, design logic and write code for customization of the software using LIMS Basic and SQL.
• Involved with the investigative site on issues concerning current clinical trials
• Collaborate with stakeholders to determine user requirements. Translate requirements into a global LIMS and lead the design of solution and its review with all stakeholders.
• Configure analytical analyses in LIMS/EMPOWER for the product release testing.
• Review validation documents and troubleshoot LIMS issues.
• Validated technical designs created by IT developers against functional specifications.
• Handled change requests and updated documents related to change.
• Reviewed system-testing results with the project and technical teams.
• Tested application manually and verified actual with expected results.
• Conducted UAT to validate that developed system meets the required design.
• Involved in test cases review to analyze the functional coverage and reviewed defects status in JIRA.
• Conducted UAT to validate that developed system meets the required design.

Environment: Windows XP, MS Office (MS Word, MS Excel, MS PowerPoint, MS Visio 2007), UML,SQL,LIMS, Agile.

Confidential, Minneapolis, MN

Business Analyst

Responsibilities:

• Identified and validated high potential business oppurtunities for stakeholders and develop customized business strategies that are aligned with corporate strategic objectives
• Interviewing business area experts, asking detailed questions and carefully recording the requirements in a format that can be reviewed and understood by both business people
• Conducted JAD sessions to develop an architectural solution that the application meets the business requirements, resolve open issues and change requests
• Prepared business process models that includes modeling of all the activities of business from conceptual to procedural level
• Followed the UML based methods using Rational Rose and Vision to create use cases, activity diagrams/ state chart diagrams, sequence diagrams, collaboration diagrams
• Assuring that all validation documentation such as IQ’s, PQ’S, Process validation, cleaning validation and software validation are in compliance with CGMP’s
• Wrote documentation for all aspects of the computer systems validation lifecycle in accordance with FDA regulations particularly CFR 21, part 11, validating processes and equipment utilized to manufacture active pharmaceutical ingredients in FDA environment
• Performed unit and system testing before integrating all the separate modules for further testing to assure an efficient operation
• Involved in weekly walkthroughs, inspections and verification meetings with various stake holders in the project
• Conducted periodic software Quality Assessment meetings to come up with test metrics and guage the progress of the testing effort.

Environment: JAVA,JSP, Oracle clinical, CSS, cGMP, FDA Regulations, Windows NT, MS Office, Rational Rose, Requisite Pro