SUMMARY:

• 9+ years of experience in TrackWise, on Analysis, Configuration, Development, Upgrade, Integration, Maintenance and Testing
• TrackWise Integration experience to design and build the unidirectional and bidirectional Interfaces using TrackWise Web Services (TrackWise Inbound and Outbound) and Java\J2EE components.
• Proficient to prepare various validation documents such as System Design Specification (DS), IQ.
• Experience working in all the phases of Software Development Life Cycle using Agile and Scrum methodologies.
• TrackWise Process Design and Configuration experience:
• Deviation, Change Control, Change plan, CAPA, Action Item, Audit Management, Service Order, Complaints, Complaint Evaluation, Decision Trees, Regulatory Reports, Event

TECHNICAL SKILLS:

Product: Trackwise V6.0, 7.x, 8.x,9.x (Enterprise Quality Management Software)

Java/J2EE: Core Java, JSP, Servlet, Web service, JavaScript

Databases: Oracle, SQL server

PROFESSIONAL EXPERIENCE:

TrackWise SME

Responsibilities:

• Worked with BA and converted the requirements to FS
• Installation of TW components on cloud architecture
• Performed E2E TW configuration for CAPA process including but not limited setting up of fields, config form set up, creation of admin queries automation and notifications
• Executed seamless delivery for every sprint and performed Business Demo on the development
• Authored System Design Specification (DS) documents, performed Unit Testing and authored IQ documents
• Identified gaps in design and fine - tuned automations
• Mentoring offshore team members throughout the course of the project delivery
• Regular interfacing with customers and guiding the business in preparing the training materials
• Worked with different stakeholders to troubleshoot and fix the issues identified
• Assistance in preparing the OQ test scripts and provided support and guidance for OQ and PQ execution
• Planned, drafted and executed the cutover and project Go-LIVE activities
• Transitioned the knowledge to Operations team for post Go-LIVE

TrackWise Lead

Responsibilities:

• Full responsibility for management of the project team including resource management, one-on-one status reports, weekly status calls
• Gathered and analyzed business requirements from cross-functional client groups in an effort to design, develop and optimize software applications
• Involved in Customer interaction for understanding the requirements, change request, enhancements and Onsite-Offshore coordination.
• Implemented the following record types: Complaints, Complaint Evaluation, Decision Trees, Regulatory Reports
• Resolve Configuration and Testing issues during and after implementation. Assist in post-implementation problem analysis and production support as required
• Completed major data migration project that combined two instances of TrackWise
• Re-keyed configuration into new environment
• Managed consultants to develop data migration code
• Delivering E2E Status report for Migration Project to client
• Prepared Cost/Effort estimate for all new projects & identify resources
• Interaction with different business users, vendors and stakeholders for Project Handover

Technical Consultant

Responsibilities:

• Requirement gathering and translating into design
• Lead a team of developers and testers overseas to define application features, design, technical specification, configuration and validation testing.
• Lead the complete development team from requirement gathering to release by tracking progress against schedules, scope management and capacity planning.
• Develop technical solutions using the core TW product and utilities, create workflows, Migrate updates and handle installations/upgrades
• Implemented the following record types: Deviations, Event, CAPA, Action Item, Change Control, Tasks, Change plan, Audit Management, Product Quality Complaint
• Responsible for Installation and developing Crystal Reports
• Prepared validation documents to deploy TrackWise system into production like, Requirements Spec., Design Spec., System Test plans, Test scripts Summary Reports, RTM etc.)
• Executed IQ and OQ scripts for TrackWise upgrade
• Develop and Support interfaces with external systems
• Create/Update the design, release, test and other quality documents to stay in compliance with the GOI Quality standards.
• Quality Management for all SOX/GxP applications in an FDA regulated environment
• Conduct meetings with Business, third party vendors and several other stakeholders and manage/ensure stakeholder signoff
• Define user experience for features and build user experience prototypes

SOFTWARE DEVELOPER

Responsibilities:

• E2E management of Java/J2EE Web Application includes Analysis, Design, Development, Integration and Implementation of multi-tier applications
• Extensive knowledge in Java, J2EE, JSP, JDBC, Servlets.
• Expertise in database programming to include PL/SQL, packages, stored procedures, functions and triggers
• Experience in Java & J2EE Design Patterns like Front controller, Business Delegate, Service Locator, Session Facade pattern, Strategy pattern & various other J2EE Design patterns and MVC Framework
• Experience in developing web services applications using SOAP Architecture
• Experience in using Junit, Selenium, SOAP UI for application unit testing
• Experience in configuring and deploying applications to servers like JBoss, Tomcat, WebSphere and Web logic
• Projects Summary

Application Consultant

Responsibilities:

• Analysis, design and development of Application based on J2EE and Design Patterns.
• Developed presentation tier using JSPs, Action Tags, JSTL, Struts Tag Libraries, HTML, Java Script, and CSS.
• Used the Struts framework for managing the navigation and page flow.
• Created templates using design patterns (Business Delegate, Service Locator, and Session Façade) extensively.
• Worked with Web logic to develop and deploy complete application.
• Developed the EJB-Session Bean acts as Façade, will be able to access the business entities through their local home interfaces.
• Developed EJB-CMP Entity Beans to perform the account transactions business logic.
• The view JSP accesses the response DTO to build the user response.
• Used web services for data exchange using SOAP and XML.
• Used JIRA for Software Development issue tracking
• Wrote complex SQL Queries, PL/SQL procedures.

Systems Analyst

Responsibilities:

• Involved in the development, enhancement and maintenance of backend services and development of interfaces to interact with the backend content services.
• Designed application using object-oriented concept and design patterns.
• Development of the Services Layer component of the Application and its integration with Spring Framework, Hibernate Framework.
• Extensive use of various design patterns Singleton, Factory, Façade, etc.
• Development of service and DAO layer components using spring bean container.
• Design and Development of DAO Framework for the application using Spring Framework support over Hibernate.
• Development of DAO layer for the application using Hibernate ORM.
• Development of the Services layer and Integration with the Web Services component.
• Worked on Restful web services to consume response of API.
• Design and Development of Unit Testing framework for the Application which includes JUnit.