SUMMARY

• About 8+ years of experience in executing software validation with emphasis on Computer Systems Validation and with profound knowledge of current validation practices, FDA 21 CFR Part 11, 58, 210, 211, 312, 820, GAMP 4 and 5 guidelines, cGXP (cGMP, cGCP, cGLP, GDP), QSR, ISO and SOX.
• Good knowledge of Validation Life Cycle (VLC) and Software Development Life Cycle (SDLC) with Waterfall, Agile, Spiral, V - Model, SCRUM and Rational Unified Process Model (RUP).
• Excellent experience in validating wide variety of applications and infrastructure - SAP R/3, Excel spreadsheets, EDMS: Documentum, EQMS: TrackWise, LIMS, Learning Management System (LMS), and Laboratory Information Management System(LIMS), Data Migration, and Adverse Event Reporting System (AERS).
• Experienced in development of Validation Master Plan (VMP), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) Validation Summary Report (VSR) and Requirements Traceability Matrix (RTM) in validation deliverables.
• Experience in handling Analytical instruments like the HPLC, GC, GC-MS, LC-MS, ICP-MS, NMR and use of this knowledge in LIMS application.
• Good experience in Requirement Traceability Matrix (RTM), and Validation summary report writing.
• Good experience at System support and maintenance validation procedures such as Change control, Change Notification Form, and Incident and problem management like CAPA.
• Experience in both AERS: Oracle’s ARGUS safety and ARIS G software tools.
• Thorough knowledge of system integration for process automation with compliance to CFR Title 21 Part 11 of the FDA regulations.
• Comprehensive knowledge and extensive experience in preparing and reviewing Test Plans, Validation Protocols (Installation Qualification - IQ, Operational Qualification - OQ and Performance Qualification - PQ), Test Summary Report and Requirement Traceability Matrix(RTM).
• Proficient in developing Test Scripts, Test Cases, Test Plans, Test Procedures, Test requirements and testing standards
• Skilled in developing Standard Operating Procedures (SOP’s), policies and working instructions to comply with FDA regulations.
• Experience in GAP analysis and Preparing Remediation plans with the knowledge of Project Management.
• Extensive experience in performing ERES Risk Assessment and other Risk Based methodology and risk management tools such as FMEA and PHA.
• Proficient in performing integration testing, functionality testing, unit testing, System testing and User acceptance testing (UAT), D2D testing, E2E testing and black-box testing.
• Strong hands on experience in using automated testing tools like UFT, TestComplete, Win Runner and Load Runner.
• Good Knowledge of MS-Project, HP Quality Center, MS Visio, Live Link and Documentum.
• Positive and Negative testing on various equipment’s.
• Expertise in using SQL for data validation and manipulation and managing records.
• Excellent adaptation quality to work in both individual and team work settings.
• Experience in providing authorship and oversight of thevalidation deliverables, Standard Operating Procedures, Work Practices, Policies documents, Job Aids and Business Practices.
• Sound knowledge of ITInfrastructure, Relational Database Systems, Internet Technologies, Content and Document ManagementSystems.

TECHNICAL SKILLS

Systems validation: 21 CFR part11, 210,211, GxP, SDLC, Validation Protocols (IQ, OQ, PQ), URS, FRS, UFT, validation master plan, Test scripts, SOP’s, RTM, AERS, TrackWise, Sample Manager, LIMS, summary reports, executing test scripts for validation, LMS, ELN.

Test Tools: EmPower,TestComplete,Cucumber,QualityCenter/HPALM,UFT/QTP,Load runner and Win Runner.

Medical Instrumentation: Agilent chemstation (HPLC/GC: LC-MS), Waters Empower (HPLC), UV-VIS, Rigaku-IV(PXRD), Incubators, Centrifuges, Sterlizers, and Autoclaves e.t.c.

Operating Systems: Windows Server, XP/2000/ME/98,Mac, UNIX/Linux

Programming: C, C++, SQL, PL/SQL, HTML.

Browsers: Internet Explorer, Netscape Navigator, Firefox

Office tools: MS Word, MS Excel, MS PowerPoint, Project, Chemdraw, JMP-SAS (statistical tool for DOE), SharePoint, Visio, Documentum, Crystal Reports, Oracle-SQL, SAP, MES.

PROFESSIONAL EXPERIENCE

Confidential, Philadelphia, PA

Validation Engineer

Responsibilities:

• Developed detailed Project Plan, reviewed User Requirement Specifications (URS) and Functional Requirements Specifications (FRS)
• Reviewed and discussed Business Requirements and System Requirements with Business Analyst (BA), Project Manager (PM), IT Team members and End Users
• Reviewed Risk Assessment Documentation to check the areas with deficiency, reviewed Corrective and Preventive Action (CAPA) and drafting Remediation Plans for the project management approval after the GAP Analysis
• Developed Test Plan, Test Cases, Test Script, and Test Result Report for Manual as well as Automatic Testing
• Documentation of various stages of AERSvalidationlifecycle, in accordance with FDA CFR Part 11 regulations
• Designed and developed documentation for test strategy and test plan by understanding the business logic and user requirements for manual and automated testing
• Prepared Standard Operating Procedures (SOPs) for System Administration, Backup and Recovery, Security, Change Control, disaster Recovery, and Error and Defect Resolution
• Provided status updates for the project as per the management requires
• Developedvalidationand quality assurance programs including templates forvalidationrelated documentation such asValidationProtocols, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Experience with troubleshoot of IQ, OQ, PQ.
• Performed all phases of end-to-end testing like User Acceptance Testing, Functionality Testing, Regression Testing, GUI Testing, Negative Testing, System Testing
• Developed and Maintained the Requirement Traceability Matrix (RTM) to check the system fulfill all requirements
• Tracked, analyzed and reported the system bugs in Defect Tracking Database by Defect tracking Tool and HP Quality Center
• Performed front-end and backend testing for the Empowersoftware
• Developed Disaster Recovery Plan to make sure if the system would be recovered and will start operating as required in appropriate time line
• Assisted in Change Management Activities, Back-up and Performance Monitoring and Structured Change Control Procedures for validated AERS.
• Worked as a liaison between Business and Infrastructure groups in coordinating and supporting server patches and maintenance activities.

Confidential, Durham, NC

Computer Validation Engineer

Responsibilities:

• Performed Computer System Validation Assessment for Track-wise system to identify the validation deliverables for the project implementation
• Prepared documents for all aspects of the computer system validation life cycle and SDLC (Agile, Waterfall), in accordance with FDA design control and regulations, particularly 21 CFR Part 11.
• Developed and executed IQ, OQ and PQ protocols, prepared the VSR to summarize all the documentation and instrument validation activities.
• Reviewed and updated end to end validation documentation for TrackWise to ensure compliance with company policies and procedures.
• Gathered URS and FRS for the Chemstation Software and its integration with LabWare LIMS.
• Managed and organized requirement coverage, Test Case Management and Defect Management by communicating between Team Lead, Developers to resolve the technical issues.
• Prepared CAPA plan, test cases, test scripts, test summary reports for overall product, part wise assessment and improvement and reported concerns if any to the suppliers
• Involved in developing Requirement Specification Document, System Requirement Specification, and Design Specification.
• Created Requirement Traceability Matrix (RTM) which helped to see whether the user requirements were met with the business requirements.
• Extensively used Enterprise Data Management platform Documentum for maintaining validation life cycle documents.
• Developed test cases and wrote test scripts to perform system testing.
• Assisted in initiating and conducting Gap Analysis and Remediation Plan for lab equipment and software interfaced with LIMS for 21 CFR Part 11 compliance and prepared Deviation Reports.
• Maintained reports for devices through DHF and DMR.
• Prepared UAT test cases and mentored execution of UAT test cases to business users.
• Reviewed and Positive testing, Negative testing, Regression testing for the Chemstation software using Quality Center tool along with Back-End integration testing to ensure data consistency on front-end.
• Involved in up gradation of the software’s of the laboratory instrumentation and overcame the technical obstacles.
• Organized, developed, and managed multiple projects with effective time management and conducted meetings to discuss compliances with the FDA rules and regulation.

Confidential, Phoenix, AZ

Validation Specialist

Responsibilities:

• Designed, implemented and validated 21 CFR Part 11 compliance strategies for LabWare LIMS
• Developed Functional Assessment and Computer System Risk Assessment for LIMS after discussed it with higher level management
• Analyzed Business, User and Functional requirements to develop Test Plans, Test Cases and Test Scripts and organized requirement coverage using HP Quality Center
• Interaction with Business Owners, System Owners, Business Analyst and Technical Writers
• Requirement analysis, developed strategic, assist designing test plan, identified test conditions, designed test cases, reviewed test cases, test scripts and executed test cases
• Played a major role in performing Part 11 Assessments, especially contributing to the components involved in maintenance of Electronic Records (ER), Electronic Signatures (ES) and Audit Trails in accordance with 21 CFR Part 11 regulations
• Prepared Technical Design Specification charts using MS Visio
• Wrote and reviewed Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) protocols for the LIMS application
• Identified discrepancies causing failure in the OQ scripts and re-writing the OQ scripts
• Executed test cases and test scripts using automated testing tool Quick Test Professional
• Defect tracking and generating reports
• Performed Operational Qualification (OQ) activities for the LIMS application
• Re-executed the OQ scripts to make sure the scripts are updated with the current system specification and the system meets the functionalities specified in the URS and FRS
• Used Quick Test Professional (QTP) to automate the Regression Test cases and executed for different releases
• Developed the release notes at the end of the build with the list of the defect summary and the test cases executed
• Performed database verification, data manipulation, reading data models
• Reviewed Corrective and Preventive Action (CAPA) and drafting Remediation Plans for the project management approval after the GAP analysis
• Reviewed and documented all Change Control Request to make sure that proposed change was on the system or not
• Developed and maintainedValidationRegistry as per FDA compliance

Confidential, Morgan Town, WV

Validation Consultant

Responsibilities:

• Analyzed user requirements and functional design documents to prepareValidationPlan to define objective, scope andvalidationstrategy of the project
• Participated in collecting user and functional requirements
• Authored documents independently such as Validation Master Plan (VMP), Function and User Requirements Specification, Test Plan, Test Scripts, Test Summary Report
• Developed software Validation protocols (IQ, OQ, PQ)
• Qualification and development to new system and software for different laboratory instruments
• Executed manual testing and documented results as per GDP as part of Validating Documentum
• Performed GAP Analysis and developed Remediation Plan for compliance with FDA regulations
• Performed System testing and documented results as part of IQs, OQs and PQs
• Executed and reviewed the Test Scripts & Operational Qualifications for the formalvalidationwith implementation of cGMP
• Maintained Requirements Traceability Matrix (RTM) to track requirements
• Reported to the developers about updates and change defects in the execution of the test scripts and test cases using HP Quality Center
• Prepared documents for Computer System Validation (CSV) in concurrence with 21 CFR Part 11
• Contributed to project review meetings and walkthroughs

Confidential, Hauppauge, NY

Validation/Compliance Analyst

Responsibilities:

• Developed Manufacturing Execution System (MES)Master Validation Plan
• Developed and executed IQ, OQ & PQ Protocols for Manufacturing Execution System (MES)
• Performed Gap Analysis, documented and defined the gaps and wrote Remediation Plan to bring the system in compliance with 21 CFR Part 11 Regulation and participated in preparing the implementation plan
• Prepared customer requirements for the system and compiling them in to Functional Requirements specifications (FRS), System Requirement Specifications (SRS), Security requirements, Electronic records and Electronic Signatures Requirements
• Experience invalidationtesting activities including User Acceptance Testing, System Testing, Integration Testing, Stress and Stability Testing
• Product evaluation with respect to requirement specifications, identifying the list of configurations which need to be standardized to prevent customization
• Responsible for conducting pilot sessions with various business areas within the organization and get the requirements, analysis and finalize the configuration parameters
• Developed enhancement for the application for new functionalities by coordinate with client and offshore technical development team for change management
• Prioritize, analyze and resolve technical issues during system implementation and release development
• Setting up test environment for each business area and demonstrate traceability to requirements
• Escalating functional problem areas of the application with vendor for enhancements and improvements and implementation of releases
• Analyzed and identified Execution and Protocol Generation Errors related to the Operational Qualification and End to End Test scripts
• Re-executed the OQ scripts for the Phase 1 project to make sure the scripts are updated with the current system specification and the system meet the functionalities specified in the URS and FRS.
• Documented the Requirement Traceability Matrix (RTM) document to track the URS and FRS are fulfilled by executing the OQ and PQ scripts
• Reported the Test Results in a structured way to Project Management or Test Coordination
• Establishing & monitoring the processes for Issue Management, Change Management and Quality Management

Confidential

Validation Analyst

Responsibilities:

• Coordinated with the project manager to write the Validation Master Plan.
• Maintained and executed validation guidelines for testing the GMP, GCP, GLP sensitive transactions.
• Developed IQ, OQ and PQ test scripts to test the application following strict GDP and 21CFR Part11.
• Responsible for the overall coverage of requirements of User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).
• Developed and analyzed Test Scripts to check the functionalities of the application for 21CFR part 11 Compliant.
• Responsible for developing the Requirement Traceability Matrix (RTM) to track requirements during QA testing phase.
• Performed Risk Assessments to verify whether the systems are Quality impacting and Part 11 compliant.
• Analyzed and documented detailed program information working and interfacing with software developers and members of various other dependent departments.
• Performed Manual Testing of the application prior to automate testing using Win Runner.
• Responsible for allocation of test assignments to the team members.