SUMMARY:

• I am a seasoned Computer System Validation professional with about 6+ Years of experience in managing multi - disciplinary teams of varying sizes and complex programs of Process Compliance
• Quality Assurance, Project Management, Business Process Analysis, Process Framework development, Risk Assessment and Profiling, Process Re-Engineering, Reviews, Audits, GxP, Regulator
• Compliance against FDA - 21 CFR Part 11 and GAMP 5.0 Framework in Pharmaceutical / Medical Device IT Compliance & Quality environment.
• Experience in Validation of Electronic Learning Management System (ELMS), Enhance Traffic Management Systems (ETMS), Statistical Analysis Software (SAS)
• Cell Bioassay Instrument software (Magellan), Excel spreadsheets, SDLC, STLC, SAP, Argus Safety Management, Laboratory Information Management System (LIMS), NuGenesis, Network and Infrastructure Qualification. Created deviation reports, exceptions and non-conformance reports.
• Adept in preparation and documentation of Validation Master Plan, IQ/OQ/PQ protocols, reports and Validation Summary Reports.
• Experience in tracking and resolving defects using Test Director and HP Quality Center (HPALM) by working closely with developers throughout Software Defect Life Cycle.
• Extensive experience in reviewing URS (User Requirement Specification), FRS (Functional Requirement Specification) and executing of IQ/OQ/PQ test cases in a GXP environment.
• Extensive experience on Test Method Validation (TMV) for attribute and variable and analytical test methods.
• Worked in PLM environment (Enovia/Agile PLM, Wind chill PDM, Omnify).
• Executed quality assurance testing for all SDLCphases of the Temenos LMS products. Conducted design analysis for new software features. Created regression test plans for new software features.
• Expertise in Manual and Automated Testing in Functional aspects of the Client-Server and Web Based Applications on multiple levels of SDLC and STLC.
• Experience of the full Software Testing Life Cycle (STLC), including - Requirements, Module, Design, Interface, Integration and Regression - Testing. Tasks include but not limited to Web based and Client server Application, Test Analysis, Test Planning, Test Case Development.
• Excellent working knowledge of Computer System Validation (CSV), developing and reviewing Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
• Good understanding for the development and review of Test Plans, Test Cases, executed protocols and final CSV reports
• Strong knowledge about FDA pharmaceutical/medical device regulations like 21 CFR Part 11, Part 210, Part 211, Part 820, ISO 13485 & 14971.
• Created Data Lifecycles for the laboratory system/equipment to identify the data integrity control checkpoints.
• Created remediation plans to describe the approach and methodology used in remediating the compliance gaps.
• Adept in using automated testing tools such as Win Runner, QTP (Quick Test Professional), Load Runner and HP Quality Center.

TECHNICAL SKILLS:

• IQ/OQ/PQ) Protocols, FDA Regulations, 21 CFR part 11
• GAP Analysis, Risk Mitigation, Remediation Strategy
• GxP (cGMP, CP, GLP, GDP)
• Environments, VMP, HP ALM
• Test Method Validation(TMV)
• Oracle Agile PLM, Axway/Cyclone
• RTM, SOP, and Summary Reports., WIN
• Mac OS, Quality Center
• Quick Test Professional, LIM
• ETQ’s AERS, ETMS, EDMS & SAP R/3.

PROFESSIONAL EXPERIENCE:

Confidential

Computer Systems Validation Engineer

Responsibilities:

• Designed, implemented and validated 21 CFR Part 11 compliance strategies for LabWare LIMS.
• Developed Functional Assessment and Computer System Risk Assessment for LIMS.
• Reviewed GxP Criticality Assessment Document, Change Control Document, 21 CFR Part11 risk assessment, Deviation Reports and Validation Summary Report. Reviewed IQ, OQ, PQ protocols, Test Plans, Change requests and manuals.
• Monitoring ETMSLab system functionality and applications suite on a daily basis.
• Installing and testing ETMS Operating System upgrades, weekly adaptations and software/patch updates.
• Applying and creating risk management plan and Analysis(SWOT) to reduce cost and waste.
• Performed Validation and Verification activities for Medical devices.
• Performed attribute and variable test method validations (TMV) in accordance to procedure.
• Completed test method and process validation(TMVs) for new instrumentation, raw material properties and component qualifications.
• Authoring SDLCDocuments like QAP, QASR.
• Reviewing the documentation for Change Request - Change Management Review.
• Proposing remediation in SDLCdocumentation for the controls that are found to be not met.
• Reviewed PFMEAs and Master Validation Plans (MVP) prior to Validation activities.Created new SOPs for new test methods and processes.
• Write various technical document such as deviation report, CAPA and root cause analysis.
• Validation Engineers to finish validation deliverable documentation and archiving for the SharePoint, Pilgrim and QC ALM document management systems.
• Validated the Weber Legitronic Labelling application for printing the serialized Labels.
• Performed requirement analysis, developed strategic planning, assisted 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.
• Working with vendors (Axway/IBM) for open issues and their fixes.
• Working on preparing the import file and the mapping document for loading data into the Agile PLM tool. Performing the data load in Agile PLM tool using the in build import function.
• Drafted documents for Computer System Validation (CSV) in compliance with 21 CFR Part11, 210,211.
• 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.
• Performed functional tests on the software that's used with Manufacturing Equipment (i.e. Bartender Label and Uson iQ Sprint).
• 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.
• Performed Functional Testing, Integration Testing, Regression Testing, System Testing, Data Driven Testing, User Acceptance Testing, front-end and back-end Testing.
• Executed test scripts in HP QC/ALM.
• Performed ISO 13485 Quality System review and ISO 14971 Risk Management audit review of medical devices, IAW 21 CFR 820
• Verify product labelling, printed materials for manufactured and marketed API's and finished pharmaceutical products.
• Work with Validation and QA teams to ensure GxP compliance and address any deviations and amendments
• Create Change Controls and CAPA's to ensure past changes, corrective actions and action items or completed.
• Performed Operational Qualification (OQ) activities for the LIMS application.
• Strong knowledge about pharmaceutical/medical device regulations/guidelines including 21 CFR Part 11, Part 210, Part 211, Part 820, ISO 13485 & 14971.
• 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.
• Analyzed Business, User and Functional requirements to develop Test Plans, Test Cases and Test Scripts and organized requirement coverage using HP Quality Center.
• Prepared Traceability Matrix between the Business Requirements and Functional Specifications.
• Lead or assist in the risk analysis process. Execute risk assessment as needed and facilitate development and completion of risk management file documentation
• Perform ECO's and Documentation remediation per ISO 13485 & FDA 21 CFR 820 with Agile PLM System
• Used Quick Test Pro (QTP) to automate the Regression Test cases and executed for different releases.
• Developed Load Runner scripts to test the load stress, execute it on Load Runner and maintained the Load Test Results.
• Closure of CAPAs as related to support validation projects.
• Create, print barcodes using BarTender software and validate print outs by using Webscan Trucheck software.
• 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.
• Responsible for Test Director Administration, assistance in test environment setup.
• Reviewed Corrective and Preventive Action (CAPA) and drafting Remediation Plans for the project management approval after the GAP analysis.
• Developed and maintainedValidationRegistry as per FDA compliance.

Confidential, Waltham, MA

Validation Engineer

Responsibilities:

• Developed validation deliverables for all phases of Systems Development Life Cycle in accordance with FDA regulations
• Defined problem statements for each Quality System Systemic CAPA per 21 CR 820.100.
• Created IQ/OQ/PQ Test Plans and test Scripts based on User and Functional Requirements Specifications (UFRS)
• Executed test scripts and document the results in accordance with Good Documentation Practices
• Reviewed risk assessments of all computerized systems
• Utilized Agile PLM and Microsoft Excel for product auditing
• Prepared validation plan (VP) for validating analytical laboratory equipment and also Labware LIMS integration with ELN.
• Manage the medical Axway/Cyclone EDI/XML data transmission system including system maintenance, enhancements, and 3rd level customer support.
• Ensuring that the clinical and medical device documents are in compliance with cGMP and GLP guidelines.
• Create validation documentation like GxP risk assessment, IQ/OQ/PQ protocols and Data Migration plan.
• Analyzed Test Scripts to check if it has covered the functionalities, which need to be in compliance with 21CFR Part 11
• Responsible for developing validation deliverables such as Validation Strategy Document (VSD), Risk Assessment, IQ/OQ/PQ Test Plans and Test Summary Reports, Requirements Traceability Matrix (RTM) and Validation Summary Report (VSR).
• Developed Test Plans, Test Cases using HP ALM.
• Perform test method Test Method Validation (TMV) to ensure use of adequate test methods.
• Supported in SOPs writing, CAPA, OOS Investigation, root cause analysis. Reviewed Test Method Validation (TMV) for all functional and interface test methods for Disposable products.
• Maintain the company Corrective and Preventive Action system (CAPA) in ETQ’sfor investigating and resolving quality problems.
• Work with cross functional teams in aligning labelling and artwork requirements meeting milestones.
• Represent regulatory affairs on labelling, advertising and promotional review and develop SOP's.
• Work with cross functional areas such as IT, Manufacturing, Engineering, Quality Control, Quality Assurance, Regulatory Affairs, Technology Development and Supply Management on validation projects
• Create and manage change orders for a client using Agile PLM software
• Completed all pending process audits/CAPA's to place SQ in compliant regulatory standing per FDA report.
• Developed and analyzed Test Scripts to check the functionalities of the application for 21CFR part 11 compliance
• Involved in Execution of the Test Scripts and writing Test Summary report
• Worked as Test Coordinator during Execution of the scripts
• Led in validation of Labware LIMS system to in corporate into company regulated computer system.
• Responsible for developing the Requirement Traceability Matrix
• Utilized HP ALM (Application Life Cycle Management) as testing tool.
• IT Validation Team lead for projects defining validation strategy, timeline and risk analysis and mitigation team
• Manage projects and timeline of direct reports and contractor, provide strategy and timelines for projects and provide validation evaluation for Change Request
• Review and approve Requirements Specifications, Design Specification, Commissioning forms and report, trace matrix and risk assessment for Building Monitor System, Building Management System, Utilities application
• Review protocols and reports for Building Monitor System, Facilities Management System, Utilities application, cleaning validation and equipment qualification
• Develop LabWare LIMS using LIMS BASIC, SQL, etc. (Currently LabWare V7)
• Revised and authored SOPs for Validation to align with regulatory and corporate Quality requirements
• Perform investigations for deviations and address CAPA

Confidential, Wilmington, NC

Validation Test Engineer

Responsibilities:

• As a member of Computer Systems Validation team, responsible for documenting and reviewing all the validation deliverables as part of validation package
• Performed regulatory and risk assessment of the computer systems.
• Performed a comprehensive Quality effectiveness audit (risk based) to the open CAPA system.
• Authored VMP (Validation Master Plan) with risk based approach for validation, leveraging documented risk assessments.
• Implement process Validation(IQ, OQ, PQ, and TMV) activities to meet cGMP requirements on time, on budget and quality to ensure that programs are compliant with inspection agencies' requirements and DSM Quality Modules.
• Responsibilities includes system qualification, assist in the design, analysis and approval of IQ, OQ, and PQ protocol scripts
• Generated and released controlled documentation to support design freeze in the Agile PLM system.
• Responsible to get QA approval for validation deliverables and Vendor Audit.
• Developed Test Plans, Test Cases using HP ALM.
• Designed, developed and implemented Test Plans using the detailed business requirements document.
• Understood data mappings and Created Test Cases and procedures.
• Configured laboratory information management systems, such as LabVantage SQL LIMS,developing validation master plans and validating LIMS implementations
• Responsible for mapping of IQ to Design Specification, OQ to Functional Specification and PQ to URS
• Communicated validation approach and requirements to team and business owner
• Maintained the Traceability Matrix between Requirements, Test cases and Defects
• Extensively involved in Defect tracking, reviewing and analyzing and reporting test result using Quality Center.
• Executed the test cases stored in the Test Plan, imported locally to the Test Lab in QC and reported the defects.
• Performed change control by assessing proposed changes to validated processes and identify the validation requirements necessary to maintain the validation status after execution of the change.
• Participate and provide assistance and technical support on technical project teams as subject matter expert on process validation regulations/procedures.
• Critically review and provide support for validation sections of regulatory submissions.
• Participated in Weekly / Monthly QA metrics reviews, provide QA status reports to management.
• Submitting daily and weekly status reports to the manager and performed timely escalations to the management.
• Maintained the Requirements Traceability Matrix (RTM).

Confidential, Durham, NC

Validation Analyst

Responsibilities:

• Reviewed and modified existing Standard Operating Systems (SOPs) for System Use SOPs.
• Wrote and reviewed IQ and OQ protocols
• Involved in writing and reviewing Requirement Traceability Matrix to track User and Functional Requirements
• Involved in writingValidationSummary Report (VSR) and archived all documents to make sure they were in compliance with 21CFR Part 11 regulations
• Prepared the test Cases by going through the Design, Functional Requirements, and User requirements
• Performed extensive Manual Testing and Black Box Testing of the application
• Documenting Test Cases for Integration, User Acceptance testing and Functional testing
• Conducted positive and negative testing manually
• Responsible for weekly status reports, updated showing the progress of Manual Testing effort and open issues to be resolved
• Responsible for writing test plans, Test scripts. Verified test results, and Wrote Test Summary Reports
• Developedvalidationprotocols and generated amendments to the protocols as required
• Documented deviations that occurred during the protocol execution