SUMMARY:

• Highly accomplished IT professional with over 10+ years of multifaceted experience in IT industry with expertise in Validation with strong background in Computer System Validation, Manual Testing, Database Testing, User Acceptance Testing, Regression Testing, Web Application Testing and Automation Testing. Experience in leading and working with Onsite and Offshore teams round the globe and Pharmaceutical/Medical, Retail and Industrial Automation domains.
• Excellent experience in the validation of highly regulated enterprise level business systems SharePoint Tools, TrackWise, HP Service Center, SAP and Inventory Management System.
• Work experience in ALM, HP Service Center, SQL server, Clear Quest.
• Validation Deliverables: Validation Plan, Summary Report, Test plan, URS, FRS, RTM, IQ, OQ, PQ protocols in compliance and conformance with FDA Regulations.
• Proficiency in Validation including specialization in 21 CFR part 11,210,211,820 compliance and GAMP, GxP’s (GMP, GLP and GCP), Regression Testing, Web Application Testing, Manual testing & Mobile Application Testing, User Acceptance Testing.
• Experience in reviewing and approving the Validation Documents including SOPs, IQs, OQs and PQs.
• Expertise in evaluating Computer System Validation (CSV) risk assessments involved in the project in accordance with FDA compliance.
• Used Track Wise tool for quality management issues and tracking applications for Corrective and Preventive Action.
• Excellent Experience in Software Development Life Cycle, Software Testing Life Cycle, Defect Life Cycle and project documentation along with Agile Methodology.
• Experience with Content Management system such and Document Management System. Experience in Developing and Executing Test Plans, Test Cases, Test requirements.
• Working experience in database systems SQL and DB2.
• Excellent experience in using Quality center 9.2, 10.0, 11.5, ALM and Clear Quest.
• Experience in leading offshore and onsite teams located in USA, Europe and Asia.
• Working experience in AutoIt and Selenium.
• Having strong analysis skill to identify the Automation opportunities in the project and provide User Inputs to implement the Automation.
• Expertise in Business Rules Management’s and Change request management process.
• Expertise in Defect Life Cycle Management and documentation.
• Expertise in problem analysis and providing solutions.
• Expertise in tracking Traceability Matrix.
• Expertise in creating Validation, Risk Assessment, Test Approach, Test Condition, UAT Test Plan, Sign - Off documents.
• Expertise in User Acceptance Testing (UAT) Planning and Execution. Expertise in development of UAT deliverables, UAT Test Approach, UAT Test Conditions, UAT E2E Test Plan, Implementation planning and UAT Reports.
• Well versed with Software Development Life Cycle, Test Life Cycle and Defect Life Cycle.
• Expert in conducting business reviews, walkthrough sessions and facilitated monthly and weekly meetings/reviews.
• Excellent organizational, interpersonal, written and oral communication skills.
• Proficient in working individually and as a part of a team.

COMPUTER PROFICIENCY:

Languages: Core Java

RDBMS: SQL and DB2

Testing Tools: Selenium, Clear Quest, Telelogic Doors and Mercury Quality Center, ALM, HP Service Center

Life Sciences: 21 CFR Part 11 (210/211, 820), GxP (GMP, GDP, GLP), GAMP, IQ, OQ, PQ, RTM, SOP, Summary Reports, Audit Trails

Operating System: Window 95/98/NT/2000, Windows XP, Windows 7, UNIX

Validation Deliverables: Validation Plan, Test Plan, URS, FRS, IQ, OQ, PQ Protocols, Sop’s/Work instructions, System problem reports and System Certification Summary/Compliance Report

Manual Testing: Test case Authoring & execution, Compatibility, functional and Regression testing, User Acceptance Testing, Bug reporting & Documentation, Test Approach, Test Plan and Test Strategy preparation and End to End Test Management

Bug trackers: Clear Quest, Quality Center, ALM and Teleology DOORS

Packages: MS Word, MS Visio, MS PowerPoint, MS Excel and MS Outlook

Release management: CVS, VSS

EXPERIENCE

Confidential, Collegeville, PA

Validation Consultant/Quality Analyst

Tools: & Technologies: Application Lifecycle Management, HP Service Center.

Responsibilities:

• Analyzed the Business requirements and assisted in preparing the Validation Plan.
• Authored and reviewed all validation deliverables: Validation Plan, URS, FRS, Trace Matrix and Qualification.
• Followed good test practices to document the test evidence (Screen Prints), Deviations,
• Resolutions and Corrective Actions.
• Performed validation for Medical Device.
• Performed change controls by assessing proposed changes to validated processes and identify the validation requirements after execution of the change using the HP Service Center.
• Developed the test scripts to test the Security User Profiles and Audit Trail to meet the
• Part 11 regulations.
• Developed and executed IQ, OQ, PQ protocols and reported deviations using ALM.
• Authored and Reviewed Qualification Interim Reports, Qualification Final Reports and Validation Summary Reports.
• Communicated audit findings and proposed remediation efforts to support resulting observations/CAPAs.
• Performed the comprehensive design failure mode effect analysis (DFMEA) and the process failure mode effect analysis for the product and the process risk assessments.
• Gathered, analyzed and created Functional Requirements Specifications (FRS).
• Conducted training to end users about System Functionality, Integrity and Configuration Requirements.
• Review and approve change control documentation.
• Maintained and updated the traceability matrix.

Confidential, Miami, FL

Quality Analyst

Tools: & Technologies: Quality Center and HP Service Center

Responsibilities:

• Analyzed the Business requirements and assisted in preparing the Validation Plan.
• Authored and reviewed all validation deliverables: Validation Plan, URS, FRS, Trace Matrix and Qualification.
• Written User Requirements specifications, Functional Requirements specifications document in compliance with 21 CFR PART 11 Requirements.
• Responsible for writing and executing Installation qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols to check installation and successful operation of the application.
• Writing test scripts for all the deliverables.
• Performed front end testing, positive and negative testing, GUI testing, and regression testing.
• Performed GAP Analysis and prepared Remediation Plans.
• Conducted reporting and tracking of defects using Quality Center.
• Utilized Documentum and created documentation in all phases of the SDLC.
• Performed Risk analysis.
• Created and maintained the Requirement Traceability Matrix (RTM) for the application.
• Responsible for storing and maintaining the documents to comply with 21 CFR Part 11 requirements.
• Responsible for developing the Data Migration Plan.
• Involved in creating System operational and Administration SOP’s.
• Executed test cases based on the test plan and in accordance with Good Documentation Practices (GDP).
• Responsible for reviewing and executing IQ/OQ/PQ test scripts.
• Responsible for performing User Acceptance Testing (UAT) for the application.
• Developed User manuals and Training manuals.

Project#2: SharePoint2010/TrackwiseV8.5.2-SharePoint2013 (Mar’11 - Aug’13)

Confidential

Quality analyst

Tools: & Technologies: Quality Center

Responsibilities:

• Analyzed and implemented the Company’s Computer Systems Validation Policy and Computer Systems Change Control Policy.
• Prepared and reviewed Validation Master Plan (VMP) and Validation Summary Report (VSR).
• Followed SDLC Methodologies and industry standard practices to Validate Computer Systems.
• Coordinated with the end users and, Gathered and documented User Requirements Specifications (URS) for various systems.
• Gathered, analyzed and created Functional Requirements Specifications (FRS).
• Developed and maintained the Requirements Traceability Matrix (RTM) in support of Validation.
• Performed Relational Security Assessment Module (RSAM), and Detailed Risk Assessment (DRA) for the Computer Systems.
• Coordinated with technical team and drafted Data Migration Plan (Clone and clean) and assisted them to complete Design review and Unit testing for all systems.
• Authored and Reviewed Application Qualification Protocol (AQP) and developed and executed Installation Qualification (IQ), Operational Qualifications (OQ) and Performance Qualifications (PQ) Protocols.
• Reviewed and approved the test execution scripts using quality center and ALM.
• Coordinated with the technical team, testers and quality team to resolve, re execute and close the defects.
• Authored and updated Operations Process Manuals and User Guidance Procedures for all SharePoint Tools.
• Routed all the documents in Product Life Cycle Management (PLM) for approvals and completed Final Document Processing after approvals.
• Coordinated with Business and IT compliance quality (QA) teams during the internal audit conducted for the SharePoint Projects.
• Provided all required documentation and HP ALM Reports whenever required.
• Authored Phase Gate Metrics Evaluation Reports and conducted meetings to decide go live.
• Authored and initiated necessary Change Control Requests for proposed improvements/ enhancements.
• Coordinated closely with entire team to meet project guide lines and time lines.
• Ensured that all Quality, training requirements are met as per Standard Guidelines.
• Worked as a liaison between development team and IT compliance quality team (QA).
• Involved in Providing technical training sessions about the functionality, integrity, configuration requirements to the end users.

Confidential

Quality Analyst

Tools: & Technologies: Quality Center

Responsibilities:

• Analyzed User and Regulatory Requirements for Computer Systems.
• Reviewed and modified existing Standard Operating Systems (SOPs) for Document management system, System Administration, Change Control Procedures and Testing SOPs.
• Designed and developed test plans, test cases, involved in both manual and automated testing.
• Developed applicable test cases for integration test, system test and acceptance test. Defects are tracked while processing testing and reported using HP Quality Center and paper based manual testing.
• Assist in project management and in the execution of functional testing, system testing, regression testing and acceptance testing.
• Written and reviewed Requirement Traceability Matrix (RTM).
• Developed and Executed Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepared a Final Validation Report.
• Reviewed various validation documents including User Requirements, System Specifications, and Validation Plan and testing documents to develop a Remediation plan.
• Worked on change control documentation such as Change Request Form (CRF’s), Change Control Implementation Plan, Change Control Summary Report.

Confidential

Programmer Analyst

Tools: Java, SQL server 2005 and Quality Center

Responsibilities:

• Designed and prepared test to validate the functionality.
• Involved in Functional and Regression test suites.
• Closely worked with on-shore and offshore interfaces in resolving the issues & Defects.
• Worked in Risk plans and mitigation approaches.
• Defect Analysis and Reporting for each build using QC.
• Preparation of weekly status reports and detailed reports using Quality center.

Confidential

Quality Assurance Engineer

Tools: & Technologies: Selenium, SQL server and Telelogic Doors

Responsibilities:

• Designed and prepared test to validate the functionality.
• Involved in Functional and Regression testing.
• Involved in the designing and preparation of Automation framework using Selenium and AutoIT.
• Involved in the debugging of the automation scripts.
• Involved in the preparation of test bed and test data.
• Involved in meetings, walkthrough's and test design & Peer reviews and documented in Quality center and Telelogic DOORS.
• Preparation of weekly status reports.
• Closely worked with on-shore and offshore interfaces in resolving the issues & Defects.

Confidential

Quality Assurance Engineer

Tools: & Technologies: .Net, JAVA, AutoIt, Selenium and Telelogic Doors

Responsibilities:

• Delivered insurance domain knowledge to team members.
• Designed and prepared test suite to validate the functionality.
• Involved in Functional UAT and Alpha testing.
• Involved in meetings, walkthrough's and test design & Peer reviews
• Preparation status reports.
• Closely worked with on-shore and offshore interfaces in resolving the issues and Defects.
• Involved in the preparation of risk mitigating approach.
• Defect Analysis and Reporting for each build.

Confidential

R&D Engineer

Tools: & Technologies: Embedded

Responsibilities:

• Involved in Designed and prepared test to validate the functionality.
• Involved in Functional and Regression testing.
• Involved in meetings, walkthrough's and test design & Peer reviews.
• Preparation of Daily status and quality reports using Mercury Quality Center.
• Closely worked with on-shore and offshore interfaces in resolving the issues and Defects.