SUMMARY:

• More than 6 years of experience in the Pharmaceutical and Bio - Pharmaceutical Domain on Computer System Validation, Technical Documentation, Quality Assurance as a Validation Engineer and Quality Analyst.
• In depth knowledge of SDLC- Software Development Life Cycle and various methodology such as Agile, Waterfall model, V model.
• Well versed with all stages of validation and testing for application such as Laboratory Management Information System (LIMS), Electronic Document Management System (EDMS), Adverse Effect Reporting System (AERS).
• Thorough understanding of FDA regulation 21 CFR Part 11, 210, 211.
• Excellent understanding of GLP, GCP, cGMP, GDP Regulation.
• Thorough knowledge of 21 CFR Part 11 Electronic record as well as Electronic signature.
• Strong experience with development and reviewing of Validation Deliverable such as Validation Master Plan, Requirement Traceability Matrix, Validation Protocols, Validation Summary Report, Remediation Plan, Gap Analysis, Plans.
• Expertise in development of Validation Protocols such as Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) Documents for GAMP-4 based computer system application.
• Hands on experience of reviewing and modifying User Requirement Specification (URS) and Functional Requirement Specification (FRS).
• Good Experience on Change Control Management Process for the Validation of Computer System.
• Proficient in creating and maintaining Validation Matrix along with Qualification Documents, Validation Status Report.
• Hands on experience reviewing, developing and executing Test Plans, Test Cases, Test Scripts, Test Scenario, Work flow Diagrams as per the FDA compliance guidelines.
• Strong experience with Automation tool such as HP Quick Test Pro, HP Win Runner and Load Runner.
• Expertise in preparation of Backup and Disaster Recovery plan.
• Thorough knowledge of Corrective and Preventive Action reporting, handling and closing using software system like trackwise.
• Hands on experience to perform Risk Assessment, Risk Analysis and Risk Mitigation strategy as per the compliance guideline.
• Good working Knowledge of Database Testing using SQL Queries.
• Thorough knowledge of various phases of Validation Life Cycle.
• Specialization in System testing, Integration Testing, Performance testing and Regression Testing.
• Capable to work independent as well as team player.
• Facilitated project status meetings, collected and reported status of testing progress and sign offs.
• Excellent interpersonal communication and writing skill.

TECHNICAL SKILLS:

Test Management Tool: Hp Quality Center, Test director 7.8/8.0

GUI: MS office, Visual Basic

Automation Test Tools: Win Runner 7.0/7.6, QTP 8.2/9.2, Load Runner 7.5/8.0/8.1

Test Management Tools: HP Quality Center 8.2/9.2, Test Director 7.8/8.0

Platforms: Unix, Windows NT/95/ 98/2000/ Vista/Window 7, MS DOS

Web Technology: HTML, .NET

Language: Java, SQL, C++

PROFESSIONAL EXPERIENCE:

Confidential

Validation Analyst / QA Analyst

Responsibilities:

• Facilitated the Computer System Validation Risk Assessment to identify Risk associated with System and developed Risk Mitigation Strategy.
• Performed Functional Risk Analysis and Risk Management for AERS during project and assigned level of severity and priority to the Risk Identified.
• Worked closely with Technical team and Business Analyst for review and update User Requirement Specification and Functional Requirement Specification.
• Reviewed Validation Deliverables throughout the entire Validation Lifecycle of the Adverse Event Reporting System (AERS).
• Developed Validation deliverable such as Requirements Specification, CSV Risk Assessment, Validation Plan, Qualification Documents, Requirement Traceability Matrix, Test plan, Test Summary reports.
• Prepared Standard Operating Procedure (SOP’s) for Deviation Handling, Revalidation, Change Control, System Administration as per the 21 CFR Part 11 Guideline.
• Assisted for developing Validation Master Plan for Oracle Adverse Event Reporting System as per the compliance guideline.
• Strictly followed SOPs and pharmaceutical industry best practice for the Validation Life Cycle Phase.
• Created all Testing Deliverable like Test Plan, Test Cases, Requirement Traceability Matrix and Testing Strategy.
• Reviewed and Prepared Qualification Protocols such as Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
• Executed Installation Qualification, Operational Qualification and Performance Qualification during Validation Life Cycle.f
• Verified Functional requirements for Graphical User Interface of the AERS Study module using the HP Quick Test Professional tool.
• Co-ordinated the Validation activities to reduce protocol execution time and to meet project milestones.
• Assisted in planning, implementing as well as documenting user acceptance testing during the validation life cycle.
• Thoroughly used HP Quality Center to track, analyze and create defect report for Test script.
• Closely worked on vendor/software assessments for compliance to 21 CFR Part 11.
• Performed back end testing for the Oracle database by pulling SQL Script.
• Created Disaster Recovery Plan to make sure that System Recovered and will start operating as required in appropriate time line.
• Created Change request using Trackwise software, Assisted in Back up and performance Monitoring and structured Change control Procedure for validated AERS.
• Developed Validation Summary Report and Overall Test Summary Report and forwarded to the Quality Assurance Team for further review.
• Provided Weekly Status Report for the project as per the management requirements.

Environment: AERS, Unix, HP Quality Center, Oracle 8.0i, Visual Basic 6, HP Quick Test Pro10.0, Window 2000, ASP, HTML

Confidential

Validation Engineer / QA Tester

Responsibilities:

• Performed Risk Assessment for the system and developed Risk Mitigation Plan for the Laboratory Information Management System (LIMS) validation.
• Worked on Gap Analysis and defined Remediation Plan to bring the system back in compliance with 21 CFR Part 11 Regulation.
• Worked with Business analyst and Technical team to developed compliance Requirement Specification as per the FDA 21 CFR Part 11 guideline.
• Participated in preparing SOPs for the Administration and Security for the validation of LIMS.
• Performed Vendor/Software Assessment for compliance with 21 CFR Part 11 and involved in the development and review of Validation Document templates.
• Developed, analyzed, reviewed and summarized Validation Documentation, Test method Data, Specification Changes.
• Developed Validation Master Plan flow chart which synthesized activity and shorten project completion time as per21 CFR Part 11 guideline.
• Developed Validation Protocols such as Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Test Plan, Validation Registry, Test Execution Report.
• Analyzed User Requirement Specification and wrote Test Cases and Test Script for Operational Qualification and Performance Qualification for LIMS.
• Executed Graphical user Interface Testing to verify Functional requirement and Regression testing using the HP Quick Test Pro and prepared execution test report.
• Actively executed test script for Functional, Regression and Integration manually as well as Automation and also created Test Execution Report as per the compliance requirement.
• Executed Performance Qualification in the Production Environment and verified User Requirements.
• Developed and maintained Requirement Traceability Matrix to reflect any changes in qualification and requirement specification documents.
• Worked on Deviation investigations, Quality System development, Documentation Control and Equipment Qualification as per the compliance requirement.
• Worked on Change Request to implement changes in the validated system as per the Change Management Process to determine impact of any changes on Validated Laboratory Information Management System.
• Traced, analyzed defect and generated bug report using HP Quality Center.
• Extensively performed backend database testing using SQL Queries.
• Created and maintained Validation Registry and Validation Summary Report.
• Thoroughly used MS word and MS Excel and PowerPoint for the presentation, Graphs, Flow charts and extensive Documentation and Reporting.
• Attended Status meeting and provided project status every week.

Environment: Window 2000, SQL-server, LIMS, ASP, Visual Basic, HP Quality Center 9.2, HP Quick Test Pro9.2

Confidential

Validation Engineer / QA Tester

Responsibilities:

• Facilitate Failure Mode and Effects Analysis for EDMS to identify associated risk to the system and provided Remediation strategy plan.
• Performed Gap analysis to rectify the gap of the current system and implemented Change Control Process as per the Change Control Management System.
• Reviewed User requirement specification and Functional Requirement Specification for EDMS by interacting with Business and Technical team.
• Created Standard Operating Procedures for Backup, Periodic Review and Change Control Management as per the FDA 21 CFR Part 11.
• Performed Software Vendor Assessment and GxP Assessment for software as per 21 CFR Part 11 guideline.
• Reviewed Computer System Validation Protocol such as Validation Master Plan, Validation Summary Report, Qualification Documents, Requirement Traceability Matrix).
• Developed and enhanced Validation Master Plan and Validation Summary Report as per the FDA compliance guideline.
• Responsible for writing Test Case and Test Scripts for the Installation Qualification (IQ) and Operational Qualification (OQ) as per the FDA Guideline.
• Created Test Plans, Test Scenarios and Detailed Test Cases based on the Use case documents, Business requirements and Functional Specification.
• Performed Functional Testing, Performance Testing, Integration Testing, System Testing according SOP’s and assured validation in compliance with cGxP’s.
• Developed and maintained Requirement Traceability Matrix to verify requirement are being met during Test Execution Phase.
• Assisted in technical writing of the User Manuals for the EDMS application as per compliance requirement.
• Executed Data-driven testing for the E-signature verification using HP Quick Test Pro by pulling different values from external file (Excel).
• Executed test cases for System testing and tracked, analyzed bug and prepared bug report in Test Director 7.0.
• Extensively used SQL queries to perform Back-end database testing using SQL Management Studio 2008.
• Assessed 21 CFR Part 11 requirements for Electronic Records and Electronic Signatures to access data security issues like authorization and login.
• Developed Business Continuity plan and also reviewed Disaster Recovery plan.
• Assisted in development of Periodic Review strategy plan to verify the system is still in validated state as per compliance requirement.
• Worked for planning, implementation and documenting User Acceptance Test cases and Test Scenario.
• Drafted Requirement Traceability Matrix to trace back Requirement with test cases.
• Collected list of all validation deliverable and created Validation Registry.
• Assisted in development of Validation Summary Report and concluded all deviation as per FDA guideline.
• Discussed project status in weekly Project meeting and process review meeting and reported Test execution results.

Environment: Windows 2000, EDMS, HP Quality Center, MS office, Visual Basic, .NET, SQL management Studio 2008, HP Quick Test Pro 9.2

Confidential

Validation Consultant

Responsibilities:

• Created Functional Risk assessment and Computer Risk assessment documents and performed risk analysis of risk identified.
• Reviewed Standard Operating Procedure (SOP’s) for the Revalidation, Disaster Recovery, Back-up Plan and Deviation Handling
• Worked closely with the Business analyst and Technical Team to gather user Requirement and translate into specification.
• Reviewed Validation Document such as Validation Master Plan, Validation Registry and Validation Summary Report.
• Reviewed and Developed Validation Protocols and Validation Summary Report as per the FDA Compliance Guideline.
• Reviewed Testing Deliverables such as Test Plan, Test Cases, Testing Strategy.
• Developed detailed Test Plans and associated Test Scripts to support, execute system/acceptance and end to end testing of all system changes.
• Executed Installation Qualification (IQ) and Operational Qualification (OQ) protocols as per the Functional Requirements and User Requirement Specification.
• Tracked requirements and developed Requirement Traceability Matrix (RTM) against System requirement specification document.
• Reviewed test script for Installation and Operational Qualification.
• Designed and maintained traceability matrix for better tracking and improve the testing process to meet the deadlines.
• Executed Functional Testing, System Testing and Integration testing as per the test scenario using Test automation tool HP Winrunner
• Created Qualification test execution report and overall test summary report throughout project life cycle.
• Performed Risk Analysis and Risk Assessment suggested remediation plan for the Data Acquisition and Reporting System.
• Provided Assurance standard operating procedure and other related documents are compliant with internal policies and cGMPs.
• Applied basic validation engineering principles to the design and implementation of system and process modification.
• Wrote SQL queries to retrieve data from the database tables to verify backend data.
• Actively involved in weekly meeting to discuss the on-going progress of the project.

Environment: .NET, Window 98, Oracle, Java, Microsoft office 2003, Visual Basic, HP Win Runner 8.2