SUMMARY

• A highly motivated individual with 7 years of experience as Quality/Validation Analyst and Validation Specialist in the field of Information Technology in diverse domains of Pharmaceutical, Healthcare, Finance, Retail and Insurance
• Extensive experience providing quality assurance, business analysis, end user and system documentation in a regulated Software Development environment
• Knowledge about FDA regulations like 21 CFR Part 11 (Electronic records and signatures), 210, 211 and 21 CFR Part 820
• Experience in GMP (Good Manufacturing Practices), GCP (Good Clinical practices), GLP (Good Laboratory practices) and GDP (Good Document Practices)
• Expertise in creating and reviewing URS (User Requirement Specifications) and Business Requirements and writing Test Plans, Test Scripts and Test Summaries
• Performed Impact Assessment, RTO Assessment, Tailoring Form, and Compliance Risk Profile for assigned applications to define associated compliance risk
• Ability to perform GAP analysis and preparing Remediation plans with knowledge of project Management and maintaining Requirements Traceability Matrix (RTM)
• Exposure in HIPPA regulations and claim transaction like 837I, 837P, 820, and 834
• Expertise with Corrective and Preventive action (CAPA) investigation and Deviation management using Trackwise
• Expertise in Reviewing, Writing, Executing and Summarizing Validation Master Plan, Validation Protocols (IQs, OQs and PQs) and Validation Summary Report
• Profound understanding of Testing/Validation Life Cycle and Software Development Life Cycle (SDLC) and multiple software development models including but not limited to Waterfall, Agile and RUP
• Experienced in developing Test plans, Test cases design, Test Summary Reports for the specific business requirements and documentation of both Manual and automated tests.
• Expertise in testing GUI Objects, Functionality and System testing including Integration, Performance, Stress, Load, Backend and Regression Testing of Client/Server and web based applications
• Excellent skills in Tera - Data, DB2, SQL Server 2005/2008 and Oracle 9i/8i RDBMS
• Expertise in Manual Testing, Automation Testing using Mercury/HP tools such as Quick Test Professional, Quality Center, Load runner, JIRA, and Bugzilla
• Proficient in Unix/Linux shell Scripting
• Proficiency in Defect Management, including Defect creation, modification, tracking, and reporting using Industry standard Tools like Quality Center, Clear Quest
• Extensive experience in writing and executing SQL queries to perform back end testing
• Experience in supporting customers by gathering their requirements, understanding their issue, investigating the issues in-house and providing them the solutions

TECHNICAL SKILLS

Validations: FDA Regulations - 21 CFR Part 11, Part 210, Part 211 and Part 820, cGMP, cGLP, cGCP, cGDP

Operating Systems: Unix, Win200X/XP/NT/7, and Linux

Programming Languages: C, C++, Core Java, Visual Basics, Bash shell Scripting

Testing Tools: Quick Test Professional (QTP), Load Runner, Win Runner

Bug Tracking/Reporting: Quality Center, Test Director, ALM

SDLC/Methodologies: Waterfall, Agile, Scrum, RUP

Databases: Teradata, Oracle 9i/10i, SQL Server 2005/2008

Web Technologies: HTML, PHP, XML, and JavaScript

Software/System Knowledge: Documentum, SAP, Oracle, MS-Office products, MS Sharepoint

Other Tools: Dreamweaver, Eclipse, Photoshop, CMDB, Service Center, IPRM, Trackwise system

PROFESSIONAL EXPERIENCE

Confidential, MA

Computer System Validation Specialist

Responsibilities:

• Interacted with Project Manager, Developers and Business Analyst to analyze and understand the user requirements.
• Created and maintained validation documents ensuring compliance with regulatory requirements.
• Involved in developing test strategies, writing validation documentation, and supporting computer system validation projects subject to 21CFR11 guidance
• Developed software testing strategies, validation test plans, writing test cases and test scripts, coordinating test script execution, analyzing test results, and writing test summery reports
• Created IQ's, OQ's, and PQ's documents and make sure were approved by assigned signatories
• Involved in writing system architecture document, Configuration specification documents
• Ensured that all validation deliverables confirm with accepted practices and testing is performed accurately, consistently, and on the project schedule
• Scheduled and lead meetings with core project team members to gain consensus on test script content, test script execution, and resolution to failures in order to meet test script objectives and updated overall status to Project manager, Confidential directors and other related assignee
• Involved on System Testing, Regression Testing and helped business users to perform the User Acceptance Testing (UAT)
• Assisted in FAT and SAT testing
• Created test data, performed Dry Run on Installation qualification scripts, System verification scripts and Test scripts to test the functionality of application in various environments

Environment: HP Quality Center 10.0, Windows XP/7, MS office suite, Oracle 11g, E-WorkBook 9.2.2

Confidential

ERP-SAP Validation Analyst

Responsibilities:

• Ensured documentation and practices meet quality standards, applicable regulatory compliance, company guidelines/policies, and SAP validation master plan
• Reviewed requirement documents and developed test cases appropriate to the stated requirements including positive and negative testing
• Review the accuracy and completeness of software validation deliverables (e.g., Requirements, IQ, OQ, UAT, Data Migration, SOPs, and Work Instructions)
• Created Validation Matrices linking approved requirements to test cases in HP QC (both system and manual)
• Collaborated with Data Migration Team, supporting for data verification audit of Hypercare Entries
• Provide support to data verifiers during production cutover; Review data verification testing and related defects
• Authored Data Migration Protocol, Data Migration Summary Report for various Confidential sites and Data Verification Summary Report for various releases
• Reviewed and Approved of MFG\QM Test Scripts using HP Quality Center and RFCs using Service Center
• Updated Right First Time Metrics and Validation Matrix to track Validation activities
• Interpreted and finalized customer requirements with SME, uploading it in 7489 Matrix and then in HP Quality center
• Expertise in the review of all deliverables across the project lifecycle, ranging from requirements documentation to final protocol reports
• Reported the status of Validation to appropriate Stakeholders
• Worked with fellow validation and project team members in a dynamic environment with shifting priorities and responsibilities
• Supported validation activities to different locations for SAP Release 6.0

Environment: HP Quality Center 10.0, Windows XP/7, MS office suite, Oracle 10i, IPRM SystemCMDB System.

Confidential

Validation Specialist

Responsibilities:

• Working closely with the Business Line / Project Manager and Technical Writers to complete the industry standard life-cycle Tailoring Form and scale deliverables (as needed)
• Reviewing industry standard life-cycle requirements documents and ensuring compliance requirements are included wherever required
• Performed Impact Assessment, RTO Assessment to help project team and business sponsor to define the risk of related application
• Ensuring the completion of all deliverables as agreed in the industry standard life-cycle Tailoring Form and approving the appropriate deliverables according to the required deliverable signature matrix(DSM)
• Authoring or reviewing Compliance Risk Profiling as part of the Requirements phase of the project of High or Medium compliance risk category
• Authoring or Reviewing regulatory and process documentation as required
• Working closely with project teams in remediating out all outstanding compliance related issues & deviations before project closure, if possible
• Reviewing procedural records for projects and standard operationalized processes
• Ensuring the completion of training related to projects and guide project teams (as needed)
• Reviewing Test cases and Traceability Matrix in conjunction to one another to ensure that compliance requirements are tested, mapped correctly ( if in scope)
• Expertise in generating Compliance Requirements (CRS), guiding teams in dispositioning them and approve them in IPRM
• Involved in Change Control Processes, Gap Analysis and subsequent Remediation Plan
• Extensive experience in authoring deliverables like Compliance Summary Report and Application Declaration of Validation Memo documents at the closure of the projects
• Extensive experience to review and approve assigned RFC’s using Service Center
• Managed Project Document Hardcopies and Electronic Documents at assigned repositories and make sure all are approved by assigned signatories
• Working with project teams and various records management / retention teams to ensure that the project deliverables get approved and uploaded to the correct folder in standard repository

Environment: HP Quality Center 10.0, Windows XP/7, MS Office Suite, Oracle 10i, IPRM SystemCMDB System.

Confidential, Frisco, TX

Validation QA Tester

Responsibilities:

• Expertise in writing the documentation and execution for Computer System Validation Lifecycle in compliance with FDA regulations that include: 21 CFR Part 11, IQ, and OQ, PQ
• Authored Validation Master Plan and Validation Summary Reports
• Developed test cases, wrote test scripts and conducted Manual Testing for all the functionalities of the application
• Used Quality Center to track and report Change Requests and was also engaged in writing Deviation reports
• Managed system upgrades, enhancements and maintenance in a cGMP environment
• Created and managed documents at Sharepoint site for Project Team
• Writing test cases using business requirement, design and use case documents
• Responsible for designing test steps, requirement mapping to tests, executing tests manually, defect logging and defect reporting in HP Quality Center
• Coordinated very closely with the developers regarding functionalities and defects
• Worked with development team to resolve the testing issues
• Assisted the QA team in reviewing test cases, test plan and tested the final application for usability testing to verify whether all the user requirements were met
• Extensive experience in writing SQL queries to perform various validations
• Performed Smoke Testing, Functional Testing, System Testing, Integration Testing, Positive and Negative testing and Regression testing
• Performed End-to-End testing of different web based applications
• Involved in cross platform testing and System testing
• Documented Test Cases corresponding to business rules and other operating condition
• Developed and maintained Requirement Traceability Matrix (RTM) to cross reference the functionality to the required test cases and scripts
• Developed Data Migration Test Plan, authored and validated Data Migration Test Script
• Resolved technical issues pertaining to any hardware or software related problem

Environment: HP Quality Center 9.2, Oracle, Toad, MS Visio, Windows XP, MS office, MS Excel, HTML, JavaScript, CSS

Confidential, Pleasanton, CA

QA Tester

Responsibilities:

• Prepared test cases and prioritized them as per critical functionality that is affecting the project deliverable
• Executed the test cases and evaluated their Pass or Fail criteria
• Maintained and updated Test Plan, Test Cases and Test Environment
• Involved in testing data and to perform Smoke, Functional, Regression, Integration, System and End-to-End Testing
• Logged and tracked defects in Quality Center
• Involved in writing and execution of QTP scripts for automation testing and analyzing the automation result
• Developed and maintained test scripts and write Automation Scripts
• Checked for data validations with boundaries/limits and incorrect input of data
• Facilitated the creation, preparation, and conduct of quality assurance reviews
• Developed SQL queries and stored procedures for data integrity
• Prioritized resolution of software and specification defects along with documenting all phases of QA process using HP Quality Center
• Debugged and troubleshoot existing websites and correct errors as required for clients

Environment: HP Quality Center 9.2, QTP, Oracle, Toad, MS Visio, Windows XP, MS office, MS Excel, HTML, JavaScript, CSS.

Confidential

Software Test Engineer

Responsibilities:

• Involved in Developing various SDLC deliverables including Test Strategy Document, System Design Specifications and Test Summary Documents
• Active participant of project meetings, release meetings, and QA status meetings.
• Created Test scripts and Test scenarios using Business Requirements Document, Use Case Documents and made sure they reflect the requirements which are to be verified according to Test Plan
• Created test reports to summarize Test results from testing activities and documented open and unresolved issues in Test Summary Report
• Developed and Executed Test Cases for Integration Testing in Test Director
• Authored Test Cases for Use Acceptance Testing (UAT) and reviewed Test Scripts for the same and performed ‘Dry Run’
• Participated in developing templates, SOPs and Training materials for Project Team
• Created regression test cases in Test Director
• Logged and tracked defects in Test Director
• Involved in Creating Defect Summary Report and share it with Project Team with Weekly basis.
• Interacted with developers and various members of team to discuss and resolve defects arose during the execution with the help of Test Director.
• Worked with Test lead to develop the Requirement Traceability Matrix (RTM) for future references and audit trail

Environment: Test Director, Windows XP, MS Office Suite, HTML, JavaScript, CSS.