SUMMARY

• I am an accomplished Instrument/Equipment/Computer System Validation Engineer.
• I am experienced thriving in environments subject to FDA compliance. Written Standards, SOP’s, Protocols, Summary Reports.
• Use Cases, Functional Specifications, Design Documentation, Procedures, IQ, OQ, PQ, Regression Protocols, Test Scripts, prepare and analyze manufacturing and laboratory analytical historical data, and use root - cause analysis tools to determine root causes, and provide technical expertise to ensure that investigation corrective and preventative actions are complete, Develop, audit, validate different categories of computerized and standalone systems using risk based approach.
• I have a thorough understanding of FDA Compliance, GDP, cGMP, GLP, GAMP, 21 CFR Part 11, 58, 210 211, 820 and Risk based validation.
• I am an excellent team player to work in conjunction with other testers, developers and other team members in validation and testing complex scenarios and projects and in the maintenance of Quality Standards in Projects.

PROFESSIONAL EXPERIENCE

Confidential

VALIDATION SPECIALIST

Responsibilities:

• Responsible for performing validation of laboratory and manufacturing equipments by following current Good Manufacturing Practices (GMPs) and all other regulatory requirements.
• Worked on Computerized Equipments such as Analytical and Preparative HPLC’s, Agilent UPLC, Agilent GC/MS, Shimadzu GC, Thermo FTIR, Perkin Elmer CHNSO Analyzer, Waters SQD2-Mass Spectrometer, Thermo Mass Spectrometer, Rudolph Polarimeter, GE Sievers TOC, Mettler Toledo Karl Fischer Titrators, UV-Vis Spectrophotometer, Centrivap Evaporator, Temperature Logger.
• Hands-on experience validating equipment associated softwares such as Empower & LC ReSponder (HPLC’s), Empower & OpenLab CDS (UPLC’s), MassHunter Data Acquisitions/Quantitative and Qualitative Analysis (GC/MS), GC Solution (Gas Chromatograph), OMNIC (FTIR), EA Data Manager (CHNSO Analyzer), MassLynx (SQD2-MS), XCalibur (Thermo MS), AutoPol V Plus (Polarimeter), LabX (Coulometric KF Titrator), elproLOG ANALYZE/elpro LOG USER (Temperature Logger) and MadgeTech Software.
• Developed validation documentation including User Requirement Specification (URS), Functional Design Specifications (FDS), Installation, Operational and Performance qualification (IQ, OQ, PQ), Validation Summary Reports (VSR), Requirement Traceability Matrix (RTM).
• Prepared User and Administrative Standard Operating Procedures (SOPs) and provided training to users for operation of laboratory and manufacturing systems.
• Coordinated and executed validation change control activities for new and existing equipments and softwares.
• Performed decommissioning activities for equipments and softwares in laboratory and manufacturing environments.
• Performed System Criticality and Functionality Impact Assessment and Component Level Risk Assessment, 21 CFR Part 11 Assessments, Periodic System Audit Trail (SAT) Review with co-operation of subject matter experts (SMEs) of respective systems for laboratory and manufacturing systems.

Confidential

IT VALIDATION/QUALITY MANAGEMENT SPECIALIST

Responsibilities:

• Developed, finalize, and execute validation activities to support Gilead’s Global initiative to implement Aggregation solutions at Corporate level, CMO’s and site levels.
• Developed risk-based Validation Plan (VP) and Requirements Risk Assessment (RRA) for Aggregation and Serialization level Enterprise systems to determine Validation Testing Strategy.
• Prepared, review, execute and peer-review Installation, Configuration, Operational and Performance qualification protocols for enterprise systems (Axway, SAP Advanced Track and Trace system) and middleware applications (Gilead’s Hybrid Integration Platform and Enterprise middleware system).
• Created test plans, test sets, execute test runs and manage defects using HP ALM EApprove test management tool.
• Acquired and maintained up-to-date knowledge of product serialization and aggregation, serial number management process and track and trace elements of aggregation program per industry standards.
• Quality Records Management (Change Management and CAPA)
• Supporting IT Quality Records team (IT-QRT) to drive change controls in TrackWise application from initiation to closure for various Gilead IT infrastructure and Oracle ERP system, including managing Corrective and Preventive Action (CAPA) records to ensure systems remain in validated state.
• Created, obtain stakeholder approvals and track activities for Validation Change Control in TrackWise conforming to Good Documentation Practices, GAMP 5 and FDA Regulations (21 CFR Part 11).
• Review and facilitate effectiveness check monitoring and close Corrective and Preventive Action records (CAPA).
• Oversee critical month-end change controls pertaining to client Purchase Orders, Internal Sales Orders, Worked Orders and Shipments received for Gilead manufactured drug products.
• Collaborated with cross-functional partners (Technical Leads, Validation Leads, IT Security Leads, Corporate QAs, and System Managers) to close problem records on time.

Confidential

QC VALIDATION ENGINEER

Responsibilities:

• Ensuring GxP Instruments, Computer Systems, and Quality Control Laboratory systems are maintained in a qualified state.
• Conducting ERES assessment to determine Electronic Record and Electronic Signature compliance (21 CFR Part 11) for computerized systems.
• Working as a team lead during verification and validation execution.
• Responsible for development, execution and review of protocols (IQ, OQ, PQ) for Shimadzu UV-2501 Spectrophotometer (UVProbe Software), Karl Fischer Titrator with Analytical Balance (LabX 2016 Software), Malvern Particle Size Analyzer (Malvern Morphologi G3SE Software), Thermo UV Spectrophotometer (VISION Security Application), Bohlin Shear Rheometer, Perkin Elmer CHNSO Analyzer (EA Data Manager Software).
• Serve as Administrator to lock-down date/time and asset IDs (enable user control functionality) on all on-site Analytical Balances & pH Meters.
• Contributing directly to the completion of projects through development and execution of validation change control.
• Participate in calibration activities, authoring SOPs (Operational and PM/Cal), system impact assessments, criticality assessments, risk assessments and validation protocols for new functionality, system changes and modifications, and periodic revalidation.
• Participating on cross-functional project teams with the support of Quality and Validation groups to estimate and plan testing activities, create and maintain schedule.
• Responsible for quality oversight, technical guidance, and validation of laboratory computerized systems by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and regulatory requirements.
• Involved in troubleshooting and providing technical support for computerized laboratory systems.
• Supporting corrective actions including investigating and resolving deviations as related to validation.

Confidential

VALIDATION TESTER

Responsibilities:

• Worked on change control documentation such as Change Request Form (CRF’s), Change Control Implementation Plan, Change Control Summary Report.
• Validated Medical devices in accordance with FDA 21 CFR Part 820.
• Worked on a Technical File containing all the specifications and safety and performance issues.
• Upload of the SIT (System Integration) and UAT Test scripts in HP ALM.
• Responsible for reviewing the incomplete sections of the Data Migration - Phase 1 document from the system and updating the document as per the current configurations in the system.
• Involved in validating the Track Wise CAPA (Corrective Action Preventive Action) Business Workflow.
• Validated the Integration of the CAPA Workflow with the other business workflows and the interfaces for the Track Wise workflow.
• Documented Installation Qualification (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ) documents using standard templates.
• Responsible for reviewing validation deliverables like Validation Plan, User Requirement specification, Functional requirement Specification documents.
• Developed Traceability Matrix to track the requirements during the QA Testing Phase.
• Executed test cases to verify Track Wise functions, Workflow, Queries, Scope, End-End flow Approvals, permissions, and Reports.
• Used TrackWise to provide secure access to authorized users to initiate new problems and incidents of any type into the system.
• Developed IQ/OQ/PQ test plans, traceability matrices, deviation forms and validation summary reports (VSR).
• Developed and executed IQ/OQ/PQ test plans and test scripts.
• Reviewed the edited URS/FRS/DS documents as per the change request.
• Involved in periodic auditing of the change management systems to ensure that the change management systems follow SOP.
• Experience in the use of HP Quality Center and similar tools to manage software testing and requirements.
• Involved in all the phases of Software Development Life Cycle (SDLC) methodologies throughout the project life cycle.
• Executed Black Box, Negative, Regression, and Integration &Security Tests as per the test plans and test scenarios.
• Reviewed and approved the test execution scripts in Quality Center.
• Ensured that application follows 21 CFR Part 11 and cGxP regulations.
• Ensured that all the change controls follow GxP/PDMA regulations before they are closed out.
• Responsible for writing test plans, test scripts and executing them for validation testing.
• Expert level knowledge in reviewing and modifying standard operating procedures (SOP).