Engineer Quality

Cell: +1-817-***-****

E-Mail: *****.*********@*****.***

SUMMARY

. Two years of experience as a Research and Development Engineer at

University of Texas at Arlington.

. Internship at Siemens Medical Solution for one year which involved

quality improvement.

. Experience in Calibration, Testing and Inspection of Medical devices.

. Strong Validation experience in Computer system Validation and

Equipment validation.

. Extensive knowledge and experience of GMP, GLP, Six Sigma, Quality

standards, MDD, FDA, ISO 9001, IS0 16949, IS0 17025, 21 CFR, Quality

Audits, Statistical Process Control (SPC), FMEA techniques, SOP, GD&T

and CAPA, Lean Manufacturing, Mistake proofing, V&V, Validation

protocols (IQ, OQ, PQ).

. SAS programming experience for two years.

CERTIFICATIONS

. ASQ Certified Quality Engineer (Pursuing in June 2010)

. ASQ Certified Quality Technician (October 2009)

. Certified SAS Programmer (September 2009).

EDUCATION

Master of Science in Biomedical Engineering, December 2009, The University

of Texas at Arlington, Texas, USA.

Bachelors of Biomedical Engineering, June 2007, D. J. Sanghvi, Mumbai

University: Mumbai, India.

COMPUTER SKILLS

Computer System Validation - 21CFR Part 11(210/ 211), GAMP, cGxP cGMP,

cGDP, cGLP), IQ, OQ, PQ, RTM, UR, FS, SOP's, Summary Reports, Audit

Trails

Statistical Software - Minitab, Statistical, SAS

Testing Tools - QTP, Win Runner, Load Runner

Databases - Oracle, MySQL, MS Access, SQL Server

Other Tools - Documentum, Matlab, C, C++, SolidWorks, SimuLink, Lab View

WORK EXPERIENCE

Validation Engineer/Technical Writer, GE, Danville, IL

Jun 2010 - Present

. Experience in authoring Standard Operating Procedures for various

business processes at Walgreens.

. Authoring User acceptance testing procedures.

. Analyzing different processes and performing Risk Analysis.

. Computer system validation of internal software like Filenet, Lawson

Graduate Research Assistant, University of Texas at Arlington.

Jan 2008 - Dec 2009

. Experience of GLP, Calibration and Testing of Optical needle probe.

. Protocol Designing, Animal Study, Clinical Data Acquiring, Report

Compilation and documentation, Blood Phantom Studies, Clinical Data

Analysis and Statistical inferences.

. Validated and maintained the Scientific Data Management system.

. Statistical analysis of the acquired data using Statistical Analysis

System (SAS) programming.

. Preparing and maintaining of detailed reports, documents and

presentations

. Experience in performing clinical trials according to IRB and IACUC.

Quality Assurance / Validation Engineer at Sovereign Pharma, Daman, India

Jan 2007-July 2007

. Supports and initiates sampling procedures and statistical process

control methods

. Validation of Aseptic Filling processes and moist heat sterilization.

. Conducted FMEA, FTA and experience in risk management.

. Assess Change Requests when needed and conduct impact analysis.

. Independently authored documents such as Master Validation Plan,

Function and User Requirements Document, Test Plan, Test Scripts, and

Test Summary.

. Conducted Audits in compliance with GLP and GMP.

. Performed Computer Systems Validation using cGxP Guidelines, like

mandating GMP and GLP.

. Performed Gap Analysis and developed Remediation Plan for compliance

with FDA regulations.

Internship at Siemens Medical Solutions, Goa, India.

Jan 2006 - December 2006

. Testing and Calibration of the X-ray generators, Quality inspection,

Quality improvement methods.

. Analyzed data using SPC tools calculating Cpk and Cp and recommended

improvements and implemented approved changes.

. Interfaced with Operations for nonconforming material disposition.

. Engineered the Research and Development (R&D) department documentation

system to support and minimize audit findings in the Design History

File (DHF)

. Supported quality control activities (including, FMEA, hazard

analysis, IQ/OQ/PQ, etc.)

. Supported and initiates standards and methods for inspection, testing,

and evaluation of production and product quality conformance.

. Developed a Validation Master Plan (VMP) to document the intent of

validation effort in accordance with FDA regulations and Prepared

Validation Summary Report (VSR) to summarize the overall validation

effort

. Supports and initiates sampling procedures and statistical process

control methods

. Performed Gap Analysis and prepared Remediation Plans to fix the gaps

identified

. Developed procedures including flow charts for implementing CAPA.

.PRESENTATIONS AND PUBLICATIONS

. "Optical Reflectance Spectroscopy for Detection of Human Prostate

Cancer" Vikrant Sharma, Dheerendra Kashyap, Aditya Mathkar, Sweta

Narvenkar, Karim Bensalah, Wareef Kabbani, Altug Tuncel, Jeffrey

Cadeddu, Hanli Liu, presented at 31st Annual International IEEE EMBS

Conference, 2009.

. "Development of multi-channel reflectance spectroscopy using short

separation for detecting neurohemodynamic change in pain." Poster

presented at Annual Celebration of Excellence by Students (ACES) 2009,

and World's Best Technologies 2009.

. Vikrant Sharma, Jiwei He, Sweta Narvenkar, Dheerendra Kashyap, Yuan Bo

Peng, and Hanli Liu, "Quantification of Optical Properties of Tissue

and Its Application to Study of Pain Mechanism in Rats," SPIE,

Photonics West, BiOS Biomedical Optics Symposium, January 2009.

HONORS AND ACTIVITIES

. Member of National Society of Leadership and Success, UTA chapter,

November 2009.

. Member of American Society of Quality (ASQ) and Regulatory Affairs

Professional Society (RAPS).

. Received a Graduate student fellowship, Department of Bioengineering,

University of Texas at Arlington, January 2008-December 2009.

. "Goa Scholars" India, fellowship awarded for Intellectual distinction,

July 2008.[pic]

Sweta Narvenkar

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