SUMMARY

• Over 7+years of experience in Computer System Validation (CSV) in both Implementation and change control of Standard, Configurable and Custom Developed Systems.
• Good knowledge on GAMP Guidelines and Risk Based Validation approach.
• Experience in validating variety of enterprise level business applications - Quality Management System (Track wise), Laboratory Instrument Management System, Learning Management System (ISO Train), Electronic Document Management System (Document), SAP Modules, Argus Safety, and Excel spreadsheets.
• Good expertise in developing the following validation deliverables - Risk Assessments, Regulatory Assessments, 21 CFR Part 11 Assessments, Gap Analysis documents, Validation Plans, Qualification Protocols (IQ/OQ/PQ test scripts), Validation Summary Reports, Deviation/Incident, & Change Controls.
• Excellent knowledge on Good Documentation Practices, Test Execution Practices, Testing Methodologies, Strategies and Software Development Life Cycle (SDLC).
• Good Experience in developing and executing Test Plan, Test case Specification and Test Release Reports for all phases of testing i.e. unit testing, Integration testing IQ, OQ, PQ and UAT Testing.
• Skilled at developing functionality Test Scripts to test functionality based on approved system requirements.
• Experience in working on various modules of LIMS, especially hands on experience in working on Sample Management with a thorough understanding on how the life cycle of samples are handled in QC.
• The way samples are run, viewed, reviewed, authored and activated.
• Good understanding on functioning of samples from sample module, Batch Module and Lot Module.
• Experience in handling in Change Control and developed Change Notification Form (CNF).
• Expert in using Quality Center for managing tests and defects.
• Thorough knowledge of system integration for process automation with compliance to CFR Title 21 Part 11 of the FDA regulations.
• Extensive experience in performing 21 CFR Part 11 Gap Analysis, and develop Remediation Plans.
• Good understanding of various life cycle methodologies Water Fall and Agile.
• Skilled in developing Standard Operating Procedures (SOPs) Policies, and Work Instructions to comply with FDA regulations.
• Experience in providing training to business users on SOPs.
• Proficient with excel to manage different testing and other activities.
• Demonstrated capabilities to quickly gain a detailed understanding of a process in order to optimize efficiencies, reduce cost, and improve quality.

TECHNICAL SKILLS

Operating System: Windows2000/2003/XP/Vista, MS-DOS

Tools: HP QC, Documentum, MS Visio, MS Project, MS Office (Word, Excel, PowerPoint, Access)

Regulations: 21 CFR (part 11, 50, 58, 210,211), Audit trail, SOX, ITIL and GAMP4/5.

PROFESSIONAL EXPERIENCE

Confidential, Plainsboro, NJ

Sr.Validation Analyst

Responsibilities:

• Developed detailed Validation Plan, reviewed User Requirement Specifications (URS) and Functional Requirements Specifications (FRS) and authored Validation plan.
• Experience in working on various modules of
• LIMS, especially hands on experience in working on Sample Management with a thorough understanding on how the life cycle of samples are handled in QC.
• The way samples are run, viewed, reviewed, authored and activated.
• Good understanding on functioning of samples from sample module, Batch Module and Lot Module.
• Discussed, reviewed and documented 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 AERS validation lifecycle, 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 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
• Developed validation and quality assurance programs including templates for validation related documentation such as Validation Protocols, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (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
• 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

Confidential, Vernon Hills, IL

Validation Analyst

Responsibilities:

• Assisted in Change Management Activities, Back-up and Performance Monitoring and Structured Change Control Procedures for validated AERS.
• Involved in the Global Implementation and Validation of Global IT applications ISO train, CAPA, CCM Workflows and IRMS.
• Responsible for maintaining the system investigation request and closing the issues after appropriate approvals.
• Authored Validation Summary Report, Test Summary Report, System Investigation Request.
• Full scale validation support at UAT phase by providing training and creation of training memos for the testers.
• Assisted in QA approval for the pre-requisites for UAT execution.
• Performance testing (Dry Run)of LIMSin DEV environment to capture defects and reported the defects to concerned departments.
• Working Cross functional in liaison between the site and global team.
• Involved in maintaining of Version control of the company’s SOP and Guidelines.
• Reviewed and updated end to end validation documentation for IRMS, Track wise (CAPA, CCM) to ensure compliance with company policies and procedures.
• Hands on review of the following deliverables - Regulatory Assessments, Risk Assessments, Validation Master Plans, Qualification Protocols, Design Reviews, User/Functional Specifications, IQ/OQ/PQ, Validation Summary Reports, Final Reports, Gap Analysis/Remediation Plans, User Manuals and Training Materials.
• Developed OQ and PQ test cases for Track wise.
• Drafted IQ test cases for verifying configuration of Track wise workflows.
• Coordinated the execution of Operational Qualifications Test Scripts with different modules and specifications.
• Conducted Regression testing and run the scripts in validated environment for performance of the application.
• Wrote IQ, OQ and PQ and developed Data migration protocols and conducted the dry run in (ALM).
• Developed Detailed Risk Assessment documentation for managing the risk levels used before validation.
• Developed Trace Matrix document for mapping the URS, FS, DS (Design Specification), IQ, OQ and PQ.
• Developed test scenarios for testing workflow paths in Track wise.
• Proficient with Corrective Action Preventive Action (CAPA) workflow including Investigation, Investigation Task, Action, Request, Request Extension and Closure phases.
• Conducted reporting and tracking of defects using Quality Center.
• Developed and maintained Traceability Matrix documents of all systems.
• Implemented cGxP’s (GMP, GLP, and GCP) and GAMP5 guidelines in the systems.
• Involved in the development of the Information Protection and Risk Management assessment.

Confidential, Indianapolis, IN

Quality Assurance Analyst

Responsibilities:

• Review and approve validation documentation including Function Specification documents, Configuration documents, Operational and Performance Qualification Protocols (OQ and PQ), test cases, deviations and reports, and requirements traceability matrices. .
• Reviewed and approved post execution of OQ and PQ test cases and defects.
• Ensure documentation meets quality standards, applicable regulatory compliance and company guidelines.
• Monitor and advise on quality of all deliverables and report to management.
• PQ test scenarios building and prelim work on traceability, to ensure all requirements are covered and tested.
• Manually Tested Functionality of Asset Accounting and its Account Determination
• Develop effective control and concepts by examining and evaluating business reports.
• Review requirements and specifications in medical device environment.
• Provide expertise in review of all deliverables across the project lifecycle.
• Ensure documentation meets quality standards, applicable regulatory compliance and company guidelines.
• Review and approve Post execution of OQ test cases and defects.
• Track configuration changes, validate and approve the transports in the validated SAP client.
• Reviewed and approved validation documentation including OQ, test protocols, test cases, defects and reports, and requirements traceability matrices.
• Experience in working on various modules of LIMS, especially hands on experience in working on Sample Management with a thorough understanding on how the life cycle of samples are handled in QC.
• The way samples are run, viewed, reviewed, authored and activated.
• Good understandings on functioning of samples from sample module, Batch Module and Lot Module.
• Prepared workflow in HPQC Quality center for approval of test case and defects.
• Used HPQC Quality Center to review and approve test cases, results, and defects.
• Prepared reports and charts in HPQC Quality Center for defects and test execution process
• Conducted presentation for daily meeting on defect status and execution process to the plan.
• Provided guidance and training to ITS department on the development and execution of validation plans.
• Provided expertise in review of all deliverables across the project lifecycle.
• Ensured documentation meets quality standards, applicable regulatory compliance and company guidelines.
• Reviewed and approved both Pre-execution and Post execution of OQ test cases and defects.
• Worked on pre-execution approvals for UAT test scripts that are automated for Regression Testing.
• Worked on post-execution approvals for UAT scripts, which involves Manual and also automation.
• Reviewed defects and closed in Mexico Regression test cycle.

Confidential

Validation Engineer

Responsibilities:

• Responsible for developing Validation Plan, IQ/OQ/PQ protocols and Validation Summary Report.
• Developed Risk assessments and 21 CFR Part 11 assessments
• 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.
• Performed data migration using Migration utility tool.
• Performed the import and export of data using Track wise integration manager.
• Involved in creating System operational and Administration SOP’s.
• Performed Periodic Reviews on regulated production computer systems.
• Developed test plans, test strategies, test scripts for validation testing along with the Test Summary Report.
• 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 coordinating User Acceptance Testing (UAT) for the application.
• Developed User manuals and Training manuals.
• Attended weekly status meetings with Team lead, Project Manager and Subject Matter Experts to update work progress.
• Extensively involved in testing phase, which includes various testing activities, like Regression Testing, Black box Testing.
• Defined various scenarios for testing the application to meet the critical requirements.
• Interacted with the Developers and Subject Matter Experts (SME) to better understand the workflow and functionalities on different modules.
• Responsible for writing Validation Summary Report to establish documented evidence that the system was validated according to the standards of 21 CFR Part 11.

Confidential

Validation Tester

Responsibilities:

• Used ECM live link document solutions to document all the deliverables
• Met clients and collected information required in order to set the minimum standards of the document
• Scheduled and conducted interviews in order to check the document requirements are met for that particular application.
• Generated and reviewed standards of CSV deliverables, documented those deliverables in compliance with 21CFR Part11, with the help of the team.
• Reviewed/Modified User Functional Requirements Specifications (UFRS).
• Developed IQ/OQ protocols as per user requirement and functional requirement specifications (URS and FRS).
• Revised Standard Operating Procedures (SOPs) to govern the development, change management, testing, release, deployment, training, document control in its Software Development Life Cycle (SDLC).
• Created flow charts in MS Visio. Assisted with Project Schedules and Task Lists. Used MS Project for scheduling and planning project activities.
• Involved in creating and maintaining Requirement Traceability Matrix (RTM) for the application.
• Involved in preparation of Validation Strategy Document.
• Developed test plans, test strategies, test scripts for validation testing. Used Test director for testing. Used Test Director as test management tool.
• Wrote Validation Summary Report to establish documented evidence that the system was validated.
• Involved in reviewing and executing PQ test scripts. Involved in System Testing with testing team, used QTP and Test director.
• Performed User Acceptance Testing (UAT) for the application.
• Performed GAP analysis, Risk assessment and documented these in live link repository.
• Developed training manuals for operating, auditing, and monitoring functions of the management system.