SUMMARY:

• 9 + years of experience in Analysis, Design, Development and Implementation of distributed system using Documentum product suite and Vendor Products like Insight publisher, FirstDoc, LIV (eCTD Viewer), Lorenz DocuBridge and CARA.
• 7+ years of experience in Pharmaceutical industry for all aspects of the computer systems validation lifecycle.
• 7+ years of Strong working knowledge (functional, technical) of various home grown and/or COTS regulatory systems (e.g. FirstDoc, CARA, Documentum, Liquent InSight and Lorenz Docubridge etc.)
• Exposed to system analysis and design, system development, integration, installation, deployment, client interaction, software development process.
• Provide support on Insight publisher, FirstDoc, LIV (eCTD Viewer), Lorenz DocuBridge, ISI Writer, Validation tools and Publishing tools to the regulatory publishers.
• Experience Documentum Administration, Support and development using Documentum Web Clients like WebTop and DFC. He has strong knowledge in Documentum product suite which includes DFC, WebTop, WDK, DAB, BPM, DQL, BOF and DA.
• Hands on experience in Cya replicator restore, CMU and backup tool.
• Deployed/supported applications on Application and Web Server‘s such as WebLogic, JBoss and Apache Tomcat Web server.
• Strong Database development experience in writing queries, functions, stored procedures, triggers, and views and Sequences in Oracle, SQL, DQL and MS Access.
• Proficient in developing applications using Eclipse 3.1, MyEclipse, NetBeans.
• Expertise in core Java, J2EE, Multithreading, JDBC and JMS.
• Proficient in using Java API’s for application development.
• Proficient in application development on Windows, UNIX and Linux environments (AIX).
• Extensively used log4J for logging and JUnit framework for unit testing across various applications.
• Knowledge & experience of Software Development Life Cycle including design, data modeling, software implementation, documentation and SOA architecture.
• Quick learner with good analytical and communication skills coupled with a proactive attitude and good team spirit.

TECHNICAL SKILLS:

Programming Languages: JAVA 1.3/1.4 / 1.5/1.6, C, C++.

EMC Documentum Tools: DFC, WebTop, WDK, DAB, BPM, DQL, BOF and DA.

J2EE Technologies: Servlets, JSP, JSTL, Struts 1.2, Hibernate, EJB, Web Services, SOAP, WSDL, JDBC, JNDI, JMS.

Web Development: HTML, JavaScript, CSS, XML, XSLT, HTML.

XML Technologies / Tools: XML, XSD, JAXP.

Application Server/ Web Server: BEA WebLogic 8.1/9.2/10gR3, JBoss 4.2, Apache Tomcat Server

Software Modeling Language: UML, Design Patterns

IDE: Eclipse, MyEclipse, NetBeans, TOAD, DQMAN.

Database: Oracle 11g/12c, PL/SQL, SQL Server 2005, MySQL, DQL

Build/Version Control Tools: SVN, CVS, VSS

Operating Systems: MS - DOS, Unix, Windows

Log Management tool: Baretail

Vendor Products: Liquent Insight, Lorenz Docubridge, LIV, Insight Validator, ISI Writer, Firstdoc, CARA and QUMAS DocComplaince

PROFESSIONAL EXPERIENCE:

Confidential, Foster City, CA

Software Developer

Responsibilities:

• Deployment and configuration of Submission Publishing System (SPS) using Lorenz Product (5.11)
• Deployment of Liquent and Lorenz tools (Insight5.1, IR server, eValidator, iSubmit etc.) Deployment and Configuration of Vendor product Liquent Insight from 5.1 version to 6.1
• Deployment of Liquent tools (Insight5.1, IR server) and Providing new builds for RDMS system
• Vendor coordination on bug fixes
• Installation and configuration of Vendor product CARA to upgrade RDMS System from Firstdoc.
• Defined and executed technical solutions while deploying the SMS, SPS and RDMS applications.
• Working on Deviation and CAPA’s for SMS, SPS and RDMS systems.

Confidential, MD,

System Analyst

Responsibilities:

• Lead for Clinical and Regulatory application support team.
• Provide “Service Desk” support for the SMART, PMD and TARDIS systems for resolving events that are beyond the technical capabilities of the Subject Matter Experts (SMEs) and Application administrators.
• Providing technical support to the submission publishers on publishing USFDA, EU submissions.
• Maintaining proper documentation (SOPs, Support Instruction, Work Instructions etc.,) in the appropriate eDMS system.
• Experience in creating the Validation Protocols (IQ, OQ, PQ), Test Plans, and Test Scripts
• Deployment of new Java-based vendor application system for Clinical and Regulatory business group.
• Patch deployments for applications based on change requirements by business and product bug fixes.
• Product versions upgrade deployments and maintenance support activities.
• Maintain the network server and network structure that will support the SMART System.
• Maintained user accounts.
• Meeting customers face to face and handling & prioritizing problems.
• Installing and configuring applications using different build technologies like Ant and DBA.
• Perform routine backups & archival of files to assist with disaster recovery.
• Escalating and identify any critical issues.
• Debugging issues by using Baretail log management tool.
• Hands on ITIL Service Support areas of Incident, Problem, Change, and Configuration Management
• Weekly standup meetings with Business users on support issues.
• Coordinate outside system service activities with the technology vendor.
• Working as System Analyst - Pharma
• Risk Assessment - IT Risk assessments
• Liquent Insight, LES, Smart link for word/pdf eCTD Submissions tools support
• Software installation/ up gradation
• Good Knowledge of GxP’s and 21 CFR part 11
• Hands on user access tools like Service-Now, open-air, Issue tracker, Cognos, onthego, Citrix, eLMS etc.
• Coordinating with client onsite and remote teams with the delivery of work.

Confidential

Lead Developer

Responsibilities:

• Module lead for Authorization process.
• Designed new components and customized various WebTop components to meet business user requirements.
• Handled change requests for existing Documentum WDK components and InputAccel processes.
• Provided support for phases delivered, like Claims Reimbursement, Authorization, Network claims applications.
• Process Design using Documentum Process Builder.
• Developed AXIS2 Web Services (Consumed) to integrate with different KPI interfaces.
• Code implemented for Workflow Auto activities.
• Code implemented for creating SBO’s.
• Code implemented for creating Documentum Jobs.
• Customization of Inbox and Search WDK Components.
• Generated reports using WDK components.
• Generated Excel Reports using Apache POI.
• SIT and UAT Support and bug fixing.

Confidential

Java & Documentum Developer

Responsibilities:

• Developed Custom Web Services using DFS for content archival and retrieval
• Deployed the custom web services in JBoss Server.
• SIT and UAT support and bug fixing