PROFESSIONAL SUMMARY:

• 9 years of experience on Validation in Pharmaceutical Industries under FDA regulations.
• Experienced in 21 CFR Part 210 & 211, 820, 58, 11 and depth knowledge of ICH Q9, EU Annex 11, GAMP 5, GLP, GCP, GMP, GDP and GPvP guidelines.
• Ensured documentation and practices meet quality standards, applicable regulatory compliance and company guidelines/policy.
• Expert in 21 CFR Part 820, ISO 13485, 14971 and 62304, FDA QSR Design Failure Mode Effects Analysis (DFMEA), Process Failure Mode Effects Analysis (PFMEA) and CAPA process.
• Participated in leading, development and execution of Validation Plan (VP), Qualification Protocols (IQ, OQ, and PQ), Hardware design software design specification (HDSDS), Relative Traceability Matrix (RTM), Validation Summary Report (VSR) for STAR & LAbvantage LIMS and various Analytical Instruments and lab informatics system.
• Extensive experience in Functional, Unit, Black Box, Stress, Load testing and Regression testing in System and User Acceptance testing.
• Broad knowledge and hands on experience, on all phases of SDLC Experience in Rational Unified Process, V - Model, Agile (Scrum and XP), Waterfall methodologies.
• Good experience in establishing project plan, milestones and metric dates and flow control of projects using Microsoft Project.
• Experienced in cross-functional activities using Corrective Action Preventive actions (CAPA), Impact Analysis, Risk Analysis, GAMP5, and System Compliance Assessment.
• Experience in writing Standard Operating Procedures and validation policies.
• Participated in periodic review process and documented Periodical Evaluation Report.
• Provided and executed Test Plan, Test Script, Test case Specification and Test Release Reports for all phases of testing like Integration and System testing.
• Excellent self-starting, interpersonal, organizational, verbal and written communication skills to handle enterprise environment and followed Good Documentation Practice.
• Worked independently and collaborated in teams with effective, multi-tasking, critical-thinking, communication and documentation capabilities.

TECHNICAL SKILLS:

• Software Development Lifecycle (SDLC)
• Scientific Data Management System (SDMS)
• Laboratory Information Management Systems (LIMS)
• Electronic Document Management/Learning Management (EDMS/LMS) System
• Electronic Lab Notebook (ELN)
• 21 CFR Part 11/210 & 211/820
• GAMP/CAPA/Change control
• GCP/GLP/GMP/GDP/GPVp/
• Trackwise 8
• HPALM
• Veeva QualityDocs
• BPLM
• Spreadsheet Validation
• Track Wise and Project Management Software Packages include Microsoft Office (Word
• Excel and PowerPoint)
• Microsoft Project
• Microsoft Visio
• Windows / 98/ 2000/2007 XP
• UNIX.

PROFESSIONAL EXPERIENCE:

Confidential, Vernon Hills, IL

Validation Engineer

Responsibilities:-

• The Project includes implementation of “CCMS, GCMS, ICAMS, QRAMS, ARISG and SCAR” workflows deployment on validated “Global Trackwise 8.5 system”.
• Authored Validation Deliverables like Validation Plan, Installation/Operational Qualification (IQ/OQ) interim report, Installation/Performance Qualification (IQ/PQ) interim report, System specification, Configuration specification, Design Review, Traceability Matrix, and Validation Final Report to release validation and production environments.
• Participated and managed Dry run, Test Plans, Test Scripts, Requirements, URS/FS, using testing tool HP Application Life Cycle Management (HPALM).
• Worked with Project Manager to provide daily status of validation activity and Project Plan to meet the Go-Live for all workflows; Change Control Management System (CCMS), Supplier Corrective Action Report (SCAR), Inspection Customer Audit Management System (ICAMS), Global Complaint Management System (GCMS).
• Managed all testing efforts with technical team, business team and Quality groups for authoring requirements, test scripts, Pre-execution review, Post-execution reviews and Defects resolution.
• Authored and approved all documentation using Veeva QualityDocs system with Technical System Owner (TSO), Business Process Owner (BPO), and Quality System Representative (QSR).
• Trained on all required procedures, training plan, e-learning modules, application specific training using ISOtrain Learning Management System (LMS).
• Conducted weekly project meetings, team meetings, and follow-up meetings and allocate various issues and deliverables.
• Provided timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues.

Tools: & Technologies: HP Application Lifecycle Management v12.5 (HPALM), Veeva QualityDocs, TrackWise 8, ISOtrain Learning Management System (LMS).

Confidential, Vernon Hills, IL

Validation Engineer

Responsibilities:-

• Project objective was “TrackWise 8 v8.5 and BaxEdge (RSS &FirstDoc) Infrastructure/Application implementation and software validation & verification testing”.
• Created and executed validation deliverables for Infrastructure like Infrastructure Design/Configuration Document (IDCD), Infrastructure Qualification Plan/Protocol (IQPP), Interim reports and Final Qualification Reports.
• Reviewed Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) test scripts pre and post execution in HPQC.
• Participated and managed Dry run, Test Plans & Test Scripts, IQ/OQ/PQ, Requirement Traceability Matrix (RTM), Test Set Reports, Defects Report, Hardware Software Design Specification (HSDS) and Validation Summary Report (VSR).
• Performed Qualification activity includes Hardware/Software configuration for VMware, UNIX, Citrix, Local zone servers for TrackWise base application and BaxEdge which is combination of ISI Regulatory Solution suite and FirstDoc.
• Developed Data Migration Plan and Data Verification Plan for TrackWise and BaxEdge applications.
• Drafted, routed and approval of validation documents; RSAM Assessment, Quality & Regulatory Assessment (QRA), User Requirements Specification (URS), Validation Plan (VP), Functional Specification, System Design Specification, Detailed Risk Assessment, Design Review, Trace Matrix, Qualification Protocol, Training Records, Application IQ/OQ/PQ Test Cases, IQ/OQ Report (Validation), IQ/PQ Report (Production), Qualification Report, Validation Final Report and System Description using TeamCenter Baxter Product Lifecycle Management (BPLM).
• Conducted weekly project meetings, team meetings, and follow-up meetings and allocate various issues and deliverables
• Provided timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues.

Tools: & Technologies: HP Quality Centre, TeamCenter Baxter Product Lifecycle Management (BPLM), TrackWise 8

Confidential, Billirica, MA

Validation Analyst

Responsibilities:-

• Project objective was “MasterControl EDMS/LMS Application version 10.1.8 software validation & verification testing.
• Participated in validation documentation; Validation Master Plan, User/Functional Requirements Specification, Design Specifications, Application Software/Hardware, Design Qualifications (DQ), Installation Qualification / Operational Qualification (IQ/OQ) Protocols and Tests, User Manuals, Performance Qualification (PQ) /User Functional Protocols and Tests, IQ/OQ/PQ Summary Reports, and Validation Summary Report.
• Authored Computer System Validation Requirement Traceability Matrix (RTM), Performance Qualification (PQ), Validation Summary Report (VSR), Test Scripts relating to the System Development Life Cycle (SDLC), 21 CFR Part 11 Regulations, Operation and Maintenance, and system-specific procedures.
• Author, review, and/or approve IT-related Standard Operating Procedures (SOP) or system-specific SOPs.
• Authored Installation Qualification (IQ), OQ, PQ, VSR for OpenLAB, MasterControl document/training management systems and backup/restore TS for Polarograph, UV-Vis, FT-IR, TOC.
• Monitored the day-to-day computer systems validation activities.
• Worked with operational users, IT organizations, Quality Assurance organization, management, and vendors on computer system validation issues.

Tools: & Technologies: MasterControl Application suites version 10.1.8, Polarograph, TOC, UV-Vis, FT-IR.

Confidential, Palm Beach Gardens, FL

Validation consultant

Responsibilities:-

• Project objective was “Lab Remediation stand-alone systems validation” and participated in all phases of SDLC starting from Validation Plan to Validation Summary Report.
• Participated in COTS stand-alone computer related system validation and delivered validation deliverables like Validation Plan (VP), User & Functional Requirement Specification (UFRS), Test Plans & Test Scripts, IQ/OQ/PQ, Requirement Traceability Matrix (RTM), Test Set Reports, Defects Report, Hardware Software Design Specification (HSDS) and Validation Summary Report (VSR).
• Experienced with Lab instruments application validation for Sensitech TempTale4, Sotax Zymark MultiDose G3, Malvern Mastersizer S & 2000, Sievers TOC 900, FTIR Spectroscopy, PE UV/Vis Lambda 25, HPLC Water and Micromeritics TriStar Surface Area and Porosity Analyzer Systems.
• Hands on Experience on HP Quality Center to generate and developing Test Plans, IQ, OQ, PQ, and all reports (Formerly Traceability Matrix, Test sets Report, Requirement Report, and Test Set Graph) in Dashboard and Executed successfully.
• Interacted with SME (Subject Matter Expert) to understand system functionality and developed & executed test scripts as per system suitability and functionality in HP Quality Center.
• Participated in editing, modifying and achieving SOP’s like: Periodic Review Procedure, Production of a User Requirements Specification, Project Change Control, Backup and Recovery Corporate Policy; Scientific Records; Scientific Signatures, Scientific Records;
• Involved in cross-functional activities using root cause analysis, risk assessment, GAMP5, Corrective action preventive action (CAPA), incident reports, change control and deviation reports.
• Ensured documentation and practices meet quality standards, applicable regulatory compliance and company guidelines/policy using sound software validation practices.

Tools: & Technologies: HP Quality Centre, Gas Chromatography, FT-IR, FT-NIR, Foss NIR, Total Organic Carbon (TOC), HPLC, Tiamo, Sotax Multidose, Malvern Mastersizer 2000,TempTale Lab instrumentation validation.

Confidential, Fort Washington, Pennsylvania

Validation Analyst

Responsibilities:-

• Project objective was “Automated lab instrument validation Commercial of the Shelf (COTS) software validation & verification testing”.
• Participated in validation activities for Tecan Bio-Pipettor System with EVOware standard/EVOware Plus V2.5 SP2 software, Perkin Elmer Plate reader with Envision v1.05 software, SpectraMax M4 Multi-Mode Microplate Reader System with SoftMax Pro GxP Version 6.2 Software, Meso Scale Detector (MSD).
• Created and executed validation deliverables like User & Functional Requirement Specification (UFRS), Dry run, Test Plans & Test Scripts, IQ/OQ/PQ, Requirement Traceability Matrix (RTM), Test Set Reports, Defects Report, Hardware Software Design Specification (HSDS), User Acceptance Test Plan (UATP) and Validation Summary Report (VSR).
• Gathered, Added, Modified requirement, executed and Reviewed validation documentation, change control, testing, execution report using ValGenesis.
• Participated in editing, modifying and achieving SOP’s like: Scientific Signatures Time Stamp, Information Technology Document Lifecycle Management Procedure, Information Technology Computer Systems Routine Maintenance, Computerized System Retirement Planning, and Information Technology Change Control Process for Computer Systems.
• Developed Decommissioning Plan for HPLC Waters System Interface.
• Gathered the Requirements by setting the meeting and acted as key liaison between System Owner, Business Owner, Benchtop and Subject Matter Expert.
• Created Operational Qualification for setup and configuration of Empower security/user groups, system policies and verification of Empower server back up and restore procedures.
• Provided project timeline and successfully completed the projects within the timeline and executed test case for Computer Related System using HP Quality Center.
• Conducted weekly project meetings, team meetings, and follow-up meetings and allocate various issues and deliverables
• Provided timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues.
• Generated Validation Summary Report for Electronic Lab Note Book System.
• Reviewed and provided guidance for Biobook Spreadsheet Validation.

Tools: & Technologies: HP Quality Centre, Tecan Bio-Pipettor system, Perkin Elmer Microplate Reader, SpectraMax M4 Multi-Mode Microplate, HPLC, Meso scale detector (MSD), Spreadsheet Validation.

Confidential, Irvine, CA

Validation Analyst

Responsibilities:-

• Project objective was “LabWare LIMS v6.0 validation assessment.
• Authored/reviewed software validation protocols like Validation Plan, IQ, OQ, PQ, Validation summary report and User Acceptance Tests.
• Documented 21 CFR Part 11 Checklist and Assessment to ensure that the system is in compliance with 21 CFR Part 11 requirements according to FDA Regulations.
• Performed Gap Analysis and Remediation of Lab instruments for 21CFR Part 11 compliance.
• Conducted Black Box, performance, ad-hoc, system level Validation testing and conducted weekly regression testing
• Drafted test scripts and ensured smooth execution of the testing Protocols,
• Reported defects and deviations and ensured Root cause Analysis of defects.
• Tracked and logged test scripts and defects in IBM Rational clear quest, Clear case, Rational Requisite Pro.
• Assisted in development of and execution of formal test plans per established guidelines to ensure quality delivery of the application under test.
• Involved in managing the development and execution of design control deliverables including software requirement documentation, test strategies including test tools, test plans and test procedures, managing defect reports and traceability mapping of business requirements.
• Involved in product validation including product quality and reliability testing, alpha/systems testing of the product, regulatory and compliance of the product.

Tools: & Technologies: 21 CFR part 11, LabWare LIMS, HP QC.

Confidential, Seattle, WA

Validation Consultant

Responsibilities:-

• Project objective was “LabVantage LIMS V6.0 validation and verification”.
• Experienced with utilizing System Development Lifecycle (SDLC) and Good Automated Manufacturing Practices (GAMP) risk based methodologies to generate protocols and define testing results
• Conducted Gap Analysis, Impact Analysis and prepared a Remediation Plan.
• Reviewed and developed Procedural and Technical Remediation plans.
• Prepared and reviewed Requirement Specification in accordance with 21 CFR part 11
• Successfully Prepared and Executed Validation Protocol documents like IQ, OQ, PQ and User Acceptance Test.
• Executed Operational Qualification for various components of LabVantage LIMS by utilizing in-house and vendor test scripts.
• Designed Performance Qualification for LabVantage LIMS by studying the business rules and interviewing the users.
• Validated Audit Trail functionality and Chromatographic Data Security Mechanism to facilitate accurate and ready retrieval of documents.
• Involved in cross-functional activities using root cause analysis, risk assessment, GAMP5, Corrective action preventive action (CAPA), incident reports, change control and deviation reports
• Developed Test Plans and executed Test scripts, prepared Test Summary Report.
• Prepared Traceability Matrix to track requirements for the software application module.
• Performed Vendor audit and documented the Vendor Evaluation Report.
• Involved in document management and project management through Documentum eRoom.

Tools: & Technologies: HP Quality Center, LabVantage LIMS, MINITAB-16.

Confidential, King of Prussia, PA

Validation Consultant

Responsibilities:-

• Project objective was configuration and support TrackWise V7.0 system validation for various business units within the company.
• Developed and configured new and existing projects by analyzing business processes, evaluating user requirements and system specifications, process flows, group categories, terminology, states and activities, permissions, login accounts, record types and settings.
• Monitored Installation, Operational, and Performance Qualification protocols, and prepared a Final Validation Report.
• Prepared SDLC deliverables such as URS, FRS and Configuration Specification documentation, including flow charts and customized reports.
• Created prototypes/demos to reflect possible implementation scenarios for the given requirements and demonstrated them to the business.
• Performed report customization using Seagate’s Crystal Reports and other reporting tools.
• Prepared appropriate training materials for the end-users and provided training.
• Resolved configuration and testing issues during and after the implementation.
• Authoring/reviewing system requirements, validation plan/report, testing protocol (IQ/OQ/PQ) from CSV Compliance's and regulatory requirements aspects.
• Developed a strong partnership with IS and business users and achieved business and project goals.

Tools: & Technologies: HP Quality Center, Trackwise Quality Management System, 21 CFR Part 11.