Quality/ Validation Engineer having 6+ years of experience in Test method validation, computer system validation (CSV), Statistical analysis, NCRs, CAPAs, Supplier quality, Design verification, Design controls, CTQs, Gap assessment, FMEA, Process validation, Software applications and process control in FDA 21 CFR 11, 210, 211, and 820 compliant environments.
Performed quality improvements and leadership within operations. Good understanding of cGxP (cGMP, GLP, and GCP).
Strong knowledge on all software development life cycles (SDLCs) like Waterfall, Agile and V-models.
Detailed understanding of the Quality Assurance process with respect to system compliance.
Experienced in developing SOPs and User Manuals in preparation to support the production system.
Used complaints analysis, authorized Hazard Analysis List (HAL) and supported system level Root Cause Analysis.
Expertise in reviewing, development and modifying documents related to Computer Systems Validation Lifecycle (CSV) such as - Validation Master Plan (VMP), Standard Operating Procedures (SOP), Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Configuration Management, Validation Summary Report (VSR), Test Summary Report, Periodic review report, designing Requirement Traceability Matrix (RTM), Deviation Reporting, Design Specification (DS), Source code Review (SCR),
Performed verification and validation testing in an FDA/UL regulated environment and maintained and FDA guidelines.
Analyzed and studied complex system requirement (Hardware and Software). Provided technical guidance in hardware and software engineering technique and automated support tools.
Proficient in developing Test Scripts, Test Cases, Test Plans, Test Procedures, Test requirements and testing standards.
Worked with R&D for new product development projects to ensure to meet customer needs in terms of reliability.
Expertise in creating test plans, manual test protocols, test reports and approval of verification test protocols and reports.
Well versed with concepts like Six Sigma, process validation, design verification, and design validation plan and reports. Provided input regarding appropriate statistical methods, test methodologies, and test equipment.
Established methodologies for verification and validation of CTQs and all product requirements.
Worked with the development teams to ensure the successful transformation of design elements into final product.
Experienced in Risk management documents and the continuous improvement tools such as FMEA, Root Cause Analysis, SPC analysis, PPAP, APQP, process mapping and process validations (Cp/CpK, PpK, Gage R&R, correlation).
Created and maintained forms such as SCAR (Supplier Corrective Action Requests), DHR (Device History Records), DMR (Device Master Records), and QIP (Quality Inspection Procedures), Supplier Audit Checklists.
Extensive experience in ALM (Application lifecycle management) and Quality center.
Validation and Execution of Data Migrations (Inter platform block based and file based).
Good Knowledge of MS-Project, HP Quality Center and MS Visio.
Excellent communication, writing and interpersonal skills and strong ability to perform as part individually and as a part of team.
Complete documents and paperwork such as Annual Product Reviews, Standard Operating Procedure training and reviews per FDA guidelines.
Expertise and experience in performing different kinds of testing like Functional Testing, GUI Testing, Backend Testing, Regression Testing, Cross Plat form and Cross Browser Testing.
Computer System Validation
21 CFR Part 11 (210/211, 820), GAMP, cGMP, GDP, GLP, IQ, OQ, PQ, RTM, SOPs, Summary Reports, Audit Trails, LIMS, CDMS, Risk Assessment.
Quality Center, ALM, Clear Quest, Win Runner, ALM.
MS Office (Word, Excel, Power Point, Access, Visio), Minitab, Adobe Frame Maker, Control Chart
MS SQL Server
Waterfall, V-Model, Agile, SPC
COMPUTER SYSTEM VALIDATION ENGINEER JULY 2017 – PRESENT
CLIENT: ZIMMER BIOMET
LOCATION: WARSAW, IN
Responsible for generating and reviewing CSV deliverables in compliance with 21CFR Part 11 and CGxP FDA.
Attended daily status meetings to give status reports and included system qualification, assist in the design, analysis and approval of IQ, OQ, and PQ protocol scripts.
Created Requirements Traceability Matrix (RTM) to track the User and Functional Requirements.
Ensured documentation meets quality standards, applicable regulatory compliance and company guidelines.
Developed the Validation Summary Report. Reviewed and approved Post execution of OQ test cases and defects.
Reviewed defects and closed in UAT test cycle and Posted UAT test execution review and approval.
Submitted daily and weekly status reports to the manager and performed timely escalations to the management. Responsible for documenting and reviewing all the validation deliverables.
Authored VMP (Validation Master Plan) with risk-based approach for validation
Responsible to get QA approval for validation deliverables and Vendor Audit.
Coordinated the execution of Operational Qualifications Test Scripts with different modules and specification
Responsible for mapping of IQ to Design Specification, OQ to Functional Specification and PQ to URS.
Extensively involved in Defect tracking, reviewing and analyzing and reporting test result using HP Quality Center
Conducted GAP analysis and prepared Remediation Plan.
Performed black box testing, positive testing, negative testing, front end testing and regression testing.
Developed applicable test cases for integration test, system test and acceptance test. Defects are tracked while processing testing and reported using HP QUALITY CENTER and paper based manual testing.
Involved in validating the Track Wise CAPA (Corrective Action Preventive Action) Business Workflow.
Expert level knowledge in reviewing and modifying standard operating procedures (SOP’s).
Developed and supported Design Control and Change Request processes and Assist in gap analysis of Design History Files (DHF) content.
QUALITY/ VALIDATION ENGINEER JULY2016 – MAY 2017
CLIENT: PHILIPS HEALTH CARE
LOCATION: WALLINGFORD, CT
Participated in creating Risk Assessment Document. Data management of performance test results using share point application.
Created issue log and uploaded in to Project share point.
Participated in Validation Life Cycle (VLC) planning, implementation and documentation
Reviewed User and Functional Requirement Documents. Tracked all deviations and corrective actions as part of test process.
Implemented Good Documentation Practices (GDP) to review and approve the Test Scripts pre-execution as well as post approval.
Reviewed Risk Assessment Documentation to check the areas with deficiency, reviewed Corrective and Preventive Action (CAPA) and Preparing Remediation Plans for the project management approval after the GAP Analysis.
Prepared Deviation Reports when the test criteria that did not meet the acceptance criteria.
Developed Requirements Traceability Matrix (RTM) to map the user requirements to the functional requirements, design specification and test script references.
Involved in Complete Software Development Life Cycle Experience (SDLC) from Business Analysis to Development, Testing, Deployment and Documentation
Performed System, Integration, Functional and GUI Testing with ALM Integration.
Worked and Reviewed the Changes Proposed on the Change Control Management System.
Participated in User Acceptance Testing (UAT) to make sure that all the user requirements are met and maintained communication with team members.
VALIDATION ANALYST FEBRUARY 2012 - DECEMBER 2015
CLIENT: BHEL (BHARAT HEAVY ELECTRICALS LIMITED)
LOCATION: HYDERABAD, INDIA
Authored validation protocols coordinated execution and summarized validation activities toComply with FDA regulations 21CFR PART 11, 820, 210, 211.
Developed/updated typical validation deliverables (Compliance Plan, Validation Plan Requirements, Protocols, and Test Scripts) and Requirement Traceability Matrix (RTM).
Provided day to day support for existing device manufacturing and the development and transition of new products into manufacturing.
Collaborated with machinists to develop standard procedures for machining of parts to
Promote consistency and reduce variation in finished products.
Involved in a balancing of an entirely manufactured steam rotor to coincide the mass axis to
the rotational axis
Incorporated Six Sigma methodologies to solve a range of design and manufacturing
Incorporated Six Sigma philosophies and methodologies when applicable to investigate and resolved a range of design and manufacturing process issues.
Executed equipment, process, Test Method Validation (TMV) and product validation.
Collaborated with cross functional teams to facilitate Risk Management activities such as referred Design History File and Design Master Record for Test plan execution as per SOP’s for design, IQ, OQ, PQ with respect to various medical device regulatory standards.
Ensured remediation of existing Risk Management documentation. Performed finding and
pulling information from previous Risk Management and formatting into new Risk Management templates and identifying gaps.
Worked on design V&V activities, including planning, characterizing, statistical sampling plans, Gage R&R, DOE’s, PFMEA generation, confidence/reliability evaluation (risk management), process equivalency evaluations (Minitab), IQ/OQ/PQ execution.
Wrote process validation documents such as URS (User Requirement Specifications) and Validation Summary Reports.
Participated in audits (FDA, TUV, and ANVISA) and responded to findings and helped in remediation.
VALIDATION ENGINEER INTERN APRIL2011–OCTOBER 2011
CLIENT: ASIA MOTOR WORKS LTD, INDIA
Involved in the validation process of Implantable cardioverter defibrillator (ICD).
Created and maintained various output reports in support of Design History Files including
Product Support Reports, Risk Assessment/Analysis, and Reliability Testing.
Performed Test Method Validation and GAP Analysis.
Involved in data collection, analysis, and creating report for metric reporting and trending.
Created Test Protocols and developed Standard Operating Procedures (SOPs).
Involved in the validation of processes including development of validation protocols,
Performing testing and writing Validation Reports.
Developed deliverables including Requirements Documents, URS, Functional/Design
Specifications, Test Protocols (IQ/OQ/PQ), and validation Summary Reports.
Recorded/ reported the results of inspections, failure analysis, material discrepancies and data.
Master of Science –Industrial Engineering 2017 University of New Haven, West Haven, CT GPA :3.6/4
Bachelor of Engineering -Mechanical Engineering 2011
Vignan’s Institute of Information and Technology, India