SUMMARY:

• Over 7 years of experience in Validation/Quality and testing of process and applications in regulated Industry.
• Good experience in using Risk Based approach to validate Category 3, 4 tools and custom developed systems.
• Excellent experience in validating wide variety of applications and infrastructure - Medical Device Tools, Business Intelligence Reports, Argus Safety, SAP, Excel spreadsheets, Electronic Document Management System (Documentum), Track Wise, LIMS, and ArisG
• Good expertise in developing the following validation deliverables - Risk Assessments, Regulatory Assessments, 21 CFR Part 11 Assessments, Gap Analysis documents, Validation Plans, Qualification Protocols, Validation reports, IQ/OQ/PQ test scripts, Deviation/Incident Reports, Change Controls and Problem Reports.
• Expert in using Quality Center for managing tests and defects.
• Experience in providing training to business users on Good Documentation and Test Execution Practices.
• Developed functionality Test Scripts to test the system functionality based on approved system requirements.
• Authored design inputs, functional requirements for legacy non-device software systems.
• Excellent knowledge of testing methodologies, strategies and Software Development Life Cycle (SDLC).
• Involved in Change Control process and Periodic Review
• Thorough knowledge of system integration for process automation with compliance to CFR Title 21 Part 11 of the FDA regulations.
• Develop 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.
• Strong hands on experience in using Quality Center, UFT and Load Runner.
• Performed various boundary tests as well as data validation to ensure record retrieval and search engine tests.
• Experience in executing software validation protocols (installation and operational qualifications.)
• Excellent knowledge of GCP, GLP, cGMP and GAMP guidelines.
• Demonstrated capabilities to quickly gain a detailed understanding of a process in order to optimize efficiencies, reduce cost, and improve quality.

PROFESSIONAL EXPERIENCE:

Confidential, Kalamazoo, MI

Validation Lead/Analyst

Environment: SAP - MDM and Data Conversion, Microsoft SharePoint, HPALM, SOLMAN, VersionOne and DocuSign.

Responsibilities:

• Guided the Global ERP implementation team to ensure that SAP system implemented as part of our Quality Management System and satisfies regulatory requirements of the FDA and other authorities like 21 CFR part 11 and 21 CFR part 211.
• Analyze Business and Technical requirements for feasibility study and propose solutions in various Integration scenarios.
• Develop Integration Solutions for cross-platform applications across the enterprise using a wide range of products.
• Lead an Off-Shore team in managing the CSV deliverables.
• Review SOPS, system documentation and User Training Manuals.
• Involved in internal audits.
• Develop and implement procedures to include Regulation into current business and product development.
• Review Functional Specifications, Design Specifications, and User Manuals and Training records.
• Managed and maintained document naming convention of all the document deliverables.
• Coordinate with Process teams for defect resolution throughout the testing cycle for Integration solutions.
• Perform Risk Assessments on computer systems, modules and individual programs. Composes and documents validation strategies, Risk Assessments, Requirements Traceability Matrices (RTM’s), Roles & Responsibilities, Installation Qualifications (IQ’s), Operational Qualifications (OQ’s), Validation Summary Reports (VSR’s), and other validation documents as needed.
• Worked with testers during the Testing cycles in various phases of testing throughout the Defect Tracking and Resolution cycles.
• Managing and organizing requirement coverage, Test Case Management and Defect Management using Quality Center.

Confidential, Minneapolis, MN

Sr. Validation Specialist

Environment: Infrastructure Qualification, Software development tools Seapine TestTrack, Surround, QA Wizard Pro, SVN, MS SQL server, TeleResponse, NetResponse, Pathway builder, Template builder, etc.

Responsibilities:

• Contributed in Planning, implementation and completion of validation projects for new implementations and enhancements.
• Worked on Data Center migration project, hand on experience in Infrastructure Validation.
• Validated Windows, Unix servers and central monitoring applications for each system.
• Worked with QA Team and subject matter experts to define and document specifications.
• Review and assess vendor validation documentation and security procedures.
• Analyze information systems and data across Enterprise platforms. Co-ordinate with the Subject Matter Experts and end-users to gather requirements, develop the application and implement the application.
• Review SOPS, system documentation and User Training Manuals.
• Coordinate with Process teams for defect resolution throughout the testing cycle for Integration solutions.
• Create Design Documents, Test Plans and Deployment plans for the Applications throughout the Integration Cycle.
• Work with testers during the Testing cycles in various phases of testing throughout the Defect Tracking and Resolution cycles.
• Author design inputs, functional requirements for legacy non-device software systems.
• Written documentation for all aspects of computer systems validation life cycle, in accordance with FDA regulations, particularly CFR Part 11.
• Guidance provided for Verification and Validation, Traceability of non-product software, manufacturing software, quality system software and software technologies used in the development, creation or production of Medical devices.
• Involved in reviewing corrective Action and Preventive Action (CAPA) and drafting Remediation plans for the project management after GAP analysis.
• Documented Validation Scope Questionnaire to determine the In-scope and out of Scope tools.
• Leads and supports validation efforts and deliverables for projects requiring validation SVN, QA WizardPro, Seapine TestTrack, etc,.

Confidential, Ann Arbor, MI

Sr. Validation Analyst

Environment: LMS (Compliance Wire), SAS, Spreadsheets, JD Edwards, Microsoft Share Point and Server Qualifications.

Responsibilities:

• Contributed in Planning, implementation and completion of validation projects for new implementations and enhancements.
• Participated in the validation of systems such as Enterprise LMS, SAS upgrade, Regulated Spreadsheets, JD Edwards and several R&D server qualifications.
• Helped in implementation of risk-based System Validation for several projects.
• Provided interpretation and guidance on corporate policies and SDLC methodologies.
• Participated in department quality improvement initiatives and actively applied quality principles.
• Created, maintained, summarized and reviewed deliverables against good documentation practices, completeness, traceability, accuracy, coverage and testability of system requirements, software defect detection, compliance risk mitigation, change management, roles and responsibilities.
• Reviewed business and technical designs, mock-ups, and other work products for new functionality/features and provided feedback as needed.
• Proactively escalated issues and risks appropriately through proper channels.
• Developed and reviewed VP, URS, FRS, TP, IQ, OQ, PQ, QR and VSR deliverables for several systems to bring them to Compliance State and to maintain validated state.
• Generated IVTP, IVPR, IVOT and VSR for several FDA regulated Spreadsheets.
• Extensive experience in prospective and retrospective Validation for Software applications.
• Involved in Remediation effort as part of Consent Decree issued by FDA
• Performed the GAP Assessment to find the gaps and generated the appropriate documentation to resolve the GAPs identified in the GAP Assessment.
• Generated SDFs (which are part of Quality Enhancement Plan) for various systems to outline the scope and status of validation for those systems providing objective evidence.
• Followed the processes and documented for compliance for GxP systems.

Confidential, NC

Sr. Validation Analyst

Environment: Trackwise, SharePoint

Responsibilities:

• Involved in the Global Implementation and Validation of SharePoint and Trackwise Audit Management Workflows.
• Reviewed and updated end to end validation documentation for SharePoint, Trackwise 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.
• Proficient with Audit workflow including Initiation, Scheduling, Action, Review, Request Extension and Closure phases.
• Developed OQ and UAT test cases for Track wise
• Reviewed and tested Crystal Reports and Business Objects reporting functionality
• Coordinated the execution of Operational Qualifications Test Scripts with different modules and specifications.
• Assisted in documentation and development of SOPs for Track wise and SharePoint applications.
• 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 Quality Center.
• Developed Detailed Risk Assessment documentation for managing the risk levels used before validation the system.
• Developed Trace Matrix document for mapping the URS, FS, DS (Design Specification), IQ, OQ and
• Developed test scenarios for testing workflow paths in Track wise.
• Conducted reporting and tracking of defects using Quality Center.
• Developed and maintained Traceability Matrix documents of all systems.
• Involved in the development of the Information Protection and Risk Management assessment
• Reviewed and updated IQ/OQ/PQ Summary Reports, Validation Final Reports and Go Live memos.

Confidential, MA

Validation Analyst

Environment: Documentum, Labware LIMS

Responsibilities:

• Involved in developing Requirement Specification Document, System Requirement Specification, and Design Specification.
• Performed Computer System Validation Assessment for Lab ware LIMS system to identify the validation deliverables for the project implementation
• Regarding documentum
• Involved in creation of Master Test Plan to strategize the test approach in various test cycles.
• Developed IQ/OQ/PQ Scripts.
• Involved in complete manual testing of the application by executing all the test cases and to check the functionality of the application.
• Involved in the documentation for protocols, Operation Qualification (OQ) and Performance Qualification (PQ).
• Managed and organized requirement coverage, Test Case Management and Defect Management using and communicating between Team Lead, Developers to resolve the technical issues.
• Conducted Installation Qualification and documented the test results, deviations and corrective actions.
• Conducted Functionality testing and Interface testing during the Operational Qualification.
• Performed the Back-End integration testing to ensure data consistency on front-end.
• Involved in executing test scripts and documented test results in Test Summary Report.
• Created Traceability Matrix to keep track of all the requirements and test scripts.

Confidential, MA

Validation Consultant

Environment: SAP R/3, DOCUMENTUM

Responsibilities:

• Developed Master Test Plan to strategize the testing approach to test SAP R/3 modules to meet the requirements defined in FRS.
• Close interaction with designers and software developers to understand application functionality and navigational flow.
• Created the strategy document that defines the SAP test environment, phases of testing, entrance and exit criteria into different phases of testing and resources required conducting the effort.
• Prepared test data for Positive and Negative testing.
• Developed test plans and test cases for Functional and Regression Testing
• Involved in executing the test scripts of SD, MM, PP, WM, IM modules of the SAP implementation.
• Followed good test practices to document the test evidence (Screen Prints), Deviations, Resolutions, and Corrective Actions.
• Developed the Test Execution Guidelines to train the business users to execute the scripts as part of UAT.
• Developed the test scripts to test the Security User Profiles and Audit Trail to meet the Part 11 regulations.
• Involved in executing the test scripts to test the interface between SAP and LIMS system (QM-IDI interface).
• Involved in validating various SAP smart forms, reports and ALVs developed using ABAP/4 language.
• Executed and reviewed the test scripts for new SAP transactions, Customized transactions, tables.
• Developed the Test Scripts to generate the Audit Trail reports to verify the creation, modifications to the records are captured in audit trail table logs.