PROFESSIONAL SUMMARY:

• Over 7 years of experience in Pharmaceutical Industry working as a Validation Analyst in Validating the Quality Data Management(QDMS), Laboratory Management System (LIMS), and Clinical Trial Management Systems (CTMS), and Drug Safety applications in Compliance with all the GCP, GLP, GMP and 21 CFR PART 11 Rules.
• Excellent testing experience in all phases of software development life cycle (SDLC) and stages of testing with good practical knowledge of testing disciplines, tasks, resources and scheduling.
• Knowledge and implementation experience of Quality Assurance, Testing Principles and Configuration and Change Management Disciplines.
• Knowledge of Cleaning Validation and Process Validation
• Experience in Prospective and Retrospective Validation.
• A good understanding of the principles of Software Validation in Regulated Industries including 21 CFR Part 11, GxPs regulations.
• Expertise in creating and executing Computer System Validation Plans, SOPs, protocols and validation test scripts and document test results in accordance with FDA standards.
• Experience in performing risk assessment using GAMP5.
• Ability to prepare Validation Master Plan and Test scripts for IQ, OQ, PQ.
• Strong hands on experience with testing tools such as Quick Test Pro and Quality Center.
• Expertise in developing Validation Plans, Test Strategies, Test Scenarios and Test Scripts for automated, as well as, manual testing for various applications to ensure proper business compliance.
• Extensive experience in Software Testing and Documentation, analysis of the Business Requirements and the Software Requirements Specifications.
• Strong hands on experience in preparing and executing OQ, PQ, Validation Plans, Test Cases, Test Scripts and Test Reports.
• Proficient in various types of testing such as functionality, Back End Testing, Smoke Testing, Regression Testing.
• Hands on experience in setting up the environment for User Acceptance Testing.

SKILL:

Testing Tools: Quality Center

Web Technologies: HTML, XML

Tools: TOAD, MS Office 2000x

Databases: Ms - SQL Server, Oracle, MS Access

Languages: J2EE, .Net

O/S: Windows Vista/NT 4.0/XP/2000/ME/95/98, UNIX

PROFESSIONAL EXPERIENCE:

Confidential, NJ

Validation Specialist

Responsibilities:

• The project involved to implement a new e-commerce portal to be launched in North America to replace the existing portals for Medical Device and Diagnostics and consumer products sectors.
• Responsible for all criticalvalidationactivities related to Project Confidential and its integrated systems.
• Experience in writingValidationmaster Plan (VMP) to document the intent of validation effort in accordance with FDA regulations.
• Provide support and guidance to Business team and IT Risk Assurance team and collect requirements to develop proper system development lifecycle (SDLC) documentation.
• Responsible for presenting Master Change Request (MCR) following the SDLC process at the Change Review Board (CRB) meetings to obtain approvals for change control.
• Expertly determine the gap between documented requirements and functionality of legacy applications and technical design specifications
• Responsible for reviewingvalidationprotocol, OQ and PQ test casesfor various applications.
• Responsible for authoring deviation reports to documenting defects in the defect tracking system identified during thevalidation process.
• Responsible for executing OQ test casesand log defectsin HP Quality Center 9.2.
• Supervise the appropriate review, approval and completion of all steps for the document.
• MaintainedRequirements Traceability Matrix (RTM) totrack requirements and correlate with the conducted test cases using QC.
• Interacted regularly with Supervisors, Analysts and Quality personnel to assessQuality control protocols.
• Involved in preparation of documents for computer systemsvalidation(CSV) in accordance to 21 CFR Part 11 and GxPs
• Experience in documentingValidationSummary Reports(VSR) and Compliance Report (CR)

Environment: Quality Center Suite 9.2, Documentum, Windows XP, MS Office, MS Visio, MS Access, Sharepoint, Java

Confidential, East Hanover, NJ

Sr. Tester / Validation Engineer

Responsibilities:

• Made sure functional requirements adhere to the validation requirements.
• Analyzed the application, Functional Requirement document and formulated the Test Plan.
• Used QC to store and organize various test cases.
• Involved in creating requirements as per testing requirements in the Master test plan and associated them with corresponding tests.
• Created and Executed Test scripts using QC
• Involved in manual testing of the GUI with regard to layout, usability and standards.
• Tested the application under the federal regulation of 21 CFR Part 11
• Assured that all validation documents such as OQ & PQ was in compliance with GxPs.
• Created the reports from test agents in QC on issues like bugs without test cases, regression testing using QTP.
• Defects wrote in QC and linked it to the requirements
• Performed (OQ/PQ) for systems to verify that they were in compliance with 21 CFR part 11 regulations.
• Tracked the validation progress through Validation Assessment Reports.
• Checked whether the execution of the e-signs were audit trailed.
• Created the Validation Summary Report to establish documented evidence that the system was validated according to the standards of CFR Part 11
• Created System requirements specifications, Traceability matrix documents, SOPs and WI in accordance with the GxPs.
• Executed the OQ and PQ test cases during the validation
• Reported Bugs through QC, interacted with developers and functional area experts and manual testing team and validated bug fixes and modifications.

Environment: Quick Test Pro, Quality Center, Documentum, HTML, Java, Java Script, XML, Oracle, Windows XP, Java

Confidential, Baltimore, MD

Validation tester

Responsibilities:

• Worked withValidation Manager in defining the boundaries ofValidationactivities in Planning.
• Created and reviewed Operation Qualifications (OQ) and Performance Qualification, test cases for different modules of LIMS based on the User and Functional Requirement specifications.
• Developed, reviewed and executed the system related IQ OQ and PQ.
• Validated Login screens and access profiles in LIMS based on the user requirements for User Interface (UI) testing.
• Reviewed, coordinated and maintainedCSVChange Controls. Prepared Periodic Reports for outstanding Change Controls.
• Translated technical information into clear, concise instructions that are standardized easily followed and understood.
• Drafted new SOPs as per Good Documentation Practices (GDP) and impact of 21 CFR Part 11 compliant data systems on day-to-day functions.
• Wrote and executed test scripts based on the test plan and in accordance with Good Documentation Practices (GDP).
• Performed backend testing by executing SQL commands using TOAD.
• Reported Variances using Defect tracking tool and re-executed upon resolution using Quality Center.
• Documented test execution report and prepared Requirement Traceability Matrix (RTM).
• Performed risk assessment using GAMP5 and FMEA.
• Performed Gap Analysis and prepared Remediation plan.
• Involved in auditing the application for 21 CFR Part 11 compliance related to Electronic Signatures and Electronic Records for a closed System.
• Maintained Change control and qualification records and maintained paper archives, controlled documents, and electronic databases.

Environment: Quality Center, Oracle, SQL, XML, J2EE, MS Office, Windows

Confidential

Validation Tester

Responsibilities:

• Analyzed system requirement specifications and developed Test Plans, Test Cases to cover overall quality assurance testing.
• Created System Requirements Specifications, Traceability matrix documents, SOPs and WI in accordance with the regulations.
• Used Quality Center for defect management tools to tracing changes and sending defect e-mail messages.
• Prepared Standard Operating Procedures (SOPs) according to required specification.
• Assured that all validation documentation such as OQ & PQ was in compliance with regulations.
• Tracked the Validation progress through Validation Assessment Reports.
• Created the Validation summary report to establish documented evidence that the system was validated according to the regulations.
• Executed the OQ, and PQ test cases during the validation.
• Involved in deviations investigation, SOPs and quality system development.

Environment: Quality Center Suite 9.0, TOAD, Windows XP, MS Office, MS Project.