Quality Assurance Engineer

Yogesh C. Jagtap

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******.******@*****.*** Cell# 978-***-****

Summary

Diverse experience in Process Equipment Validation, Lab Instrumentation validation, Computer Systems

Validation, Software Quality Testing, Risk Assessment, Change Control Management, Root Cause

Analysis, Corrective and Preventive Action, Site Validation Planning, validation strategies and

development of all related documentation

Well versed with all stages of validation and software quality testing, 21 CFR (Parts 11,210,211)

Validation, Gap Analysis, Remediation Plan, SOP Development, and Qualification (IQ/OQ/PQ)

Documentation.

Technical Summary

Experience in equipment, instrumentation and computer systems validation in compliance with FDA

standards. Experience in preparation of validation Strategy, Process Engineering, Kaye Validator

operation, Validation Master Plan, Validation protocols (IQ OQ PQ) and Validation Summary Report.

Experience in performing risk assessment, validation and Gap Analysis.

Excellent understanding of unit operations including fermentation, cell culture and protein purification,

Biochemical Processes, Validation approach to manufacturing processes and Cleaning Validation.

Proficient in creating and maintaining validation Matrix along with qualification documents, test

documents, validation status reports.

Experience

Shire Pharmaceuticals Ltd Jun 2008 – Feb 2009

Validation Consultant-Contract Position

Worked as part of team for the planning and execution of validation activities for set-up of a new Roller

Bottle facility and QC Lab Move project at ShireHGT, Lexington MA.

• Developed and executed the Installation and Operational Qualification for Cell Analysis

System, BioProfile Flex Fluid Analyzer, Spectrophotometers, Freezers, Osmometers, Weighing

Balances, Refrigerators, etc

• Developed and executed the Performance Qualification for Cell Analysis System, BioProfile

Flex Fluid Analyzer, Spectrophotometers, Freezers, Osmometers, Weighing Balances, Refrigerators, etc

• Conducted risk assessment and part 11 analysis for computer controlled lab instrumentation and

accordingly developed and reviewed SOPs

• Followed and maintained a rigorous cGMP training program

• Assisted in development of SOPs for the Cedex Cell Analysis System, BioProfile Flex Blood

Gas Analyzer, etc

• Assisted in developing and documenting maintenance and caibration programs for various lab

instrumentation

Vertex Pharmaceuticals Inc Jul 2007 – Feb 2008

Validation Consultant-Contract Position

Worked as a validation representative for software development/customization initiatives namely

VMWare Customization, Oracle Data base Upgade, Labware LIMS, Network Qualification,

SpitFire Change Control System, etc at Vertex Pharmaceuticals Inc.

Yogesh C. Jagtap

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******.******@*****.*** Cell# 978-***-****

• Developing the Validation Plans for Application/service development and manage the validation

activities and documentation for the project initiatives

• Conducting risk assessment for the product/service from regulatory/business point of view and

based the validation/testing on the level of risk

• Developed, executed and reviewed test plans, test scripts, change control requests, Validation

protocols (IQ/OQ/PQ) and test summary reports for software validation.

• Trained and provided orientation and supervision to new members of the validation team

• Solely managed the validation activities for multiple products/services through effective use of

available resources and brought them to completion

Biogen Idec Inc Jan 2007 – Jul 2007

Validation Consultant-Contract Position

Worked as a part of a validation team for the planning and execution of QC laboratory Move and

Shipping Validation Projects at Cambridge facility of Biogen Idec.

• Developed, executed and reviewed Equipment validation protocols (IQ/OQ/PQ) for freezers,

incubators, hooded chambers, incubators, fermentation tanks, Vapor Shippers, refrigerators, etc

• Conducted commissioning studies for some controlled temperature chambers like freezers,

refrigerators, hooded chambers,etc before validation

• Used Kaye Validator 2000 for thermal mapping of equipment, during execution of qualification

protocols and to generate qualification and calibration reports

• Developing the Validation Production Plan executive summary reports for completed campaigns

like Avonex, LTBeta, etc, to summarize the executed validation protocols, Change over

protocols, cleaning validations and equipment-related protocols before and after the campaign

• Executed cleaning validation protocols involving Cleaning-in-place (CIP), Cleaning-out of-place

(COP), Sterilization-in-place (SIP),swabbing,etc

• Working in tandem with quality engineering to review/correct executed protocols and then get

them approved

Perkin Elmer Inc. Jun 2006 – Dec 2006

SQA/Validation Engineer-Contract Position

I was solely responsible for the Quality Assurance and Validation analysis for two releases of ExacTag

Analysis Software – a Sequence analysis tool, which uses raw peak data from LC-MS/MS analysis to

identify and quantify protein mixtures

• Involved in the preparation of User/Functional Requirements for ExacTag Analysis Software

• Involved in developing all the testing deliverables like Test Plan, Test Cases, Requirements

Traceability matrix, Test Summary Report, etc and a testing strategy based on different project variables

like time, new features added, state transitions, etc

• Created test cases for both manual testing and automated testing.

• Involved in assessing future 21 CFR part 11 requirements for the product and made

recommendations accordingly

• Conducted Installation testing, System Testing, Backend testing, Regression testing and Acceptance

testing for the product

• Used Lotus Notes based P.S. Bugs 2.0 software for bug tracking and reporting.

Merck & Co., Inc., PA Nov 2005 – Apr 2006

Yogesh C. Jagtap

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******.******@*****.*** Cell# 978-***-****

QA/Validation Analyst-Contract Position

I was responsible for the Quality Assurance and testing Processes for Master Data Management for

Market Definition and Product. I was also involved in a related sister project – Master Data Management

for Alignment Data

• Reviewed the User/Functional Requirements to prepare a testing strategy and approach

• Involved in creation/review/approval of the following documents – Test Plan, Test Specification,

Installation Qualification, Test Cases, Requirement Traceability Matrix, Quality Assurance Plan, QA

Summary Report, Test Summary Report

• Followed Merck SLC and Merck Corporate Policies, during creation of the documents related to

testing and used Documentum as the document management system

• Reported and Managed the Defects through Rational ClearQuest

• Conducted System Testing, Integration Testing, Installation Testing, Ad-hoc testing and

Performance testing

• Conducted backend testing and data reliability testing using SQL Navigator

• Reviewed the Sarbanes-Oxley Act and verified the conformance of the product and testing activity

to this policy through scripted test cases.

Millipore Corporation, MA May 2005 – Sep 2005

Lab Process Engineer I

I was involved in the project to analyze and trouble-shoot the air integrity failure of Pellicon 2 Maxi

cassettes in Amgen’s Enbrel process.

• Wrote documentation for Validation life cycle, in accordance with FDA regulations including:

Validation plan and Protocol, Installation Qualification (IQ), Operation Qualification (OQ), and

Performance Qualification (PQ).

• Implemented and executed IQ, OQ and PQ documents for chromatography systems, autoclaves,

incubators, freezers and various analytical instruments

• Assisted in design of experiments for the projects, developed and executed SOP’s for TFF process

in a BL-2 facility

• Involved in setting up an in-house bench top pilot-scale purification system replicating the actual

Enbrel Process

• Performed Statistical Analysis of the results data from in-house runs, calculated various controlling

parameters and through failure analysis found the root cause of Air Integrity failure and made

recommendations for change in the Enbrel Process, without any change in yield of the purification

process

Millipore Corporation, MA Oct 2003 – Nov 2004

Lab Process Engineer I -Contract Position

I was responsible for analyzing the performance of different prototypes of Millipore’s Pellicon series

Tangential flow filtartin devices and make suggestions for their improvement.

• Managed Lab inventory, scheduled Calibration and Validation activities, Implemented and executed

IQ, OQ and PQ for chromatographs, autoclaves, Data Acquisition systems, Digital Thermometers,

spectrophotometers, Control Chambers and various analytical instruments

• Evaluated TFF devices and related purification processes with various designs and different

membranes for process performance, optimization and consistency studies.

• Assisted in design of experiments for various projects, develop and execute SOP’s for new TFF

products in a BL-2 facility, and perform statistical data analysis.

Yogesh C. Jagtap

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******.******@*****.*** Cell# 978-***-****

• Gathered/ Analyzed data to study model behavior of UF devices & calculate controlling parameters

• Prepared test protocols, conducted design of experiments, and assembled bench-top pilot scale

Systems for Pellicon-3 UF Cassettes characterization and scalability studies

Education

University of Massachusetts Lowell, MA, USA Aug 2001 - Oct 2003

M.S. Chemical Engineering

University College of Technology, AP, INDIA Dec 1997 - Apr 2001

B.S. Chemical Engineering

Certifications/Training

Graduate Certificate in Bioprocessing and Biotechnology

Diploma in Software Quality Assurance

Technical Skills

Testing Tools: Kaye Validator, WinRunner, QTP

Bug/CAPA Tracking: Test Director/Quality Center, Clear Quest, TrackWise

Programming languages: C, C++

Others: Documentum, MSOffice, Qdoccs, PLC, Vdoccs,

SOPVault, and Lotus Notes

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