Project Manager Software
Resume:
Krithika Rangarajan
abg60e@r.postjobfree.com
Summary
. Extensive experience of all the aspects of Validation, SOP writing,
Technical writing, Software Quality Assurance, and Testing life cycle.
. Expertise in all the stages of the Software Development Life Cycle (SDLC)
and QA methodologies.
. Excellent working knowledge of Computer System Validation (CSV),
developing and reviewing Installation Qualification (IQ), Operational
Qualification (OQ) and Performance Qualification (PQ)
. Sound knowledge of authoring Test Cases, Test Scripts.
. Proficient in dealing with Standard Operating Procedures (SOPs), Test
Plan, TrackWise, CTMS.
. Experience in developing Required Traceability Matrix (RTM)
. Competent in Quality System and Standard (cGLPs, cGCPs, and cGMPs), 21
CFR (Part 11, 210, 211, 312, 314), Gap Analysis and Remediation Plans.
. Experience in Siebel testing and TrackWise.
. Strong analytical skills with high level of energy and creativity also a
quick learner and committed to continuous self-improvement.
. Excellent communication and presentation skills and have the ability to
work efficiently in teams and independently as well.
Current Employment Status - Permanent Resident
Education - Master of Science in Biomedical Engineering, Wayne State
University, Detroit-MI
TECHNICAL SKILLS
Validation Tools 21CFRpart11,cGxP,IQ, OQ, PQ, SOPs, VSR,
VMP,SOPs, RTM, CTMS, TrackWise
Operating System Windows 98/2000/XP/Vista, Linux
Programming SQL, C, C++, Unix
Methodologies Waterfall
Databases Oracle
Packages MS Office, SharePoint Server 7.0
Academic Experience
. Experimental methods in Impact Biomechanics
Performed sled test, spine test, seat belt test and calibrated
accelerometer and analyzed the data with TDAS software in the Impact
Biomechanics lab. It involved extensive collection and analysis of data
using Excel.
. Medical Robotics & Image Guided Surgery
I was involved in building a robot arm that assisted in extending,
grabbing and retracting the objects demanded by the user. This robot
was specially designed for partially paralyzed people. The design will
let the paralyzed person to strap the robot arm into his/hers and
activate it using vocal commands to perform the desired task.
Worked on the 3d slicer software version 3.2 and created a report on
the various features of the software and its applications using MRI
images.
. Mat lab: Fluorescence Recovery after Photo bleaching Image Analyzer.
Created a program in Mat lab to help in analyze the images of a cell
that was under FRAP experiment. The program analyses the movement of
lipids in the cell.
. Smart Sensors Technology
Created an oscillator circuit using simulation software Pspice and
created a layout with the given specifications using Cadence.
Professional Experience
Takeda Pharmaceuticals, Deerfield, IL
Jan 11 - Present
Validation Analyst
I was involved in Analyzing, Recommending, Writing, Publishing and
Maintaining Technical Writing Deliverables.
Responsibilities:
. Review Documentation Deliverables to ensure consistent Standards,
Quality Delivery and Timing of Project Schedule.
. Author Documentation to describe Program Evaluation, Testing, and
Correction.
. Evaluate and Test new or modified Software Programs and Software
Development Procedures.
. Identify differences between Establishment Standards and User
Applications and suggests modifications to conform to standards.
. Involved in the development of SOPs based on functional requirements and
user requirements document related to implementing TrackWise software.
. Involved in testing phase SDLC life cycle.
. A member of the assessment team to review the 21 CFR Part 11
requirements.
. Performed system testing for CTMS eClinical upgradation project.
. Involved in analyzing the business requirements to develop validation
master plans, Test Cases and Test Scripts for TrackWise.
. Developed test scripts for manual testing of Siebel T-Rx 5.1 upgrade
project.
. Reviewed the test scripts(UAT Scripts) for approval,logged, tracked,
managed and closed change management requests pertaining to the TrackWise
release,
. Participated in updating and reviewing Requirements Traceability Matrix
(RTM) for the new release TrackWise and Siebel T-Rx.
. Participated in performing and communicating Gaps pertaining to TrackWise
validation to the team. Coordinated and reviewed SOPs regarding new
updates in software.
. Participated in the assessments for the requirements of 21CFR Part11, FDA
and GCP regulations.
Delphi Medical, Troy, MI
May 2008 - Sep 2008
Innovation & Technology Intern
Delphi Medical is a part of Delphi Automotive Corporation.
Responsibilities:
. Handled unsolicited submissions ( front end paper work, first level
review of background of technology, patent search)
. Technology scouting(examine Tech Transfer opportunities on university and
national labs websites)
. Through understanding of manufacturing process involved in automotive
products.
. Communicated with various universities and companies regarding new
technologies related to Delphi's product line.
. Scout for new products for Delphi Medical.
Ranbaxy, Hyderabad, India
May 2006 - Dec 2006
Validation Analyst
Ranbaxy Pharmaceuticals is a technology based company applying its
formulation expertise and drug-delivery technology to the development of
controlled release and niche products.When it shows positive results, the
results are submitted to FDA for approval. Then the company starts
commercial production and marketing. As a validation engineer I was
involved in formulating test plan and test scripts after analyzing business
model and software requirement for their customized sales software.
Responsibilities:
. Coordinated with System Analyst, Project Manager and Business Analyst and
reviewed and updated documentation for all aspects of Computer System
Validation lifecycle in accordance with FDA regulations, particularly 21
CFR Part 11.
. Responsible for creation of URS/FRS, Validation Plan, Validation Summary
Report.
. Prepared Change Control, Overall Risk Assessment, 21 CFR Part 11 risk
assessment, GxP Criticality Assessment and Deviation documents.
. Performed Regression Testing, Gap Analysis, GxP Risk Assessment of the
system.
. Worked with users to ensure that the UAT test scripts are accurate and
proper.
. Formulated test scripts and test scenarios after having analyzed Business
and Software Requirements and System Design Specification. Reviewed and
executed existing Test scripts. Also Dry runner prepared test scripts.
. Developed Traceability Matrix to ensure testing of each and every
requirement.
. Created Incident Reports for the bugs identified in formal testing.
. Developed and executed OQ Test Scripts for Siebel Analytics and Audit
Trials.
. Followed Change Control Procedures.
. Prepared and updated existing User Manuals. Also prepared validation
binders.
. Document all phases of system life cycle as required by FDA regulation
under 21 CFR Part 11(Electronic Records and Electronic Signatures) and to
successfully complete QA checkpoints. Reviewed validation documents.
. Involved in creating test plans for IQ, OQ, PQ test phases. Executed IO,
OQ and PQ test cases, reviewed and verified test results. Identify and
report issues, and finally provide OQ and PQ test summary reports.
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