Project Manager Management

Smitha

Email: abi2d3@r.postjobfree.com

Validation Tester

Phone: 615-***-****

Professional Summary:

. Having Around 6+ years of experience in Information Technology with

emphasis on SDLC, QMS, QA, Computer System Validation Life Cycle, 21

CFR Part 11, 210/211 validation, Good Testing Practices and Good

Documentation Practices.

. Knowledge of 21 CFR Part 820, 58, ISO 9001, GAMP software categories.

. Expert in Computer software system implementation and validation in

compliance with FDA cGXP (GMP, GLP and GCP) regulations and GAMP and

ICH standards.

. Extensive experience in Research and Preclinical Development

Information Systems (RPCDIS), Clinical Trail and Data Management

systems, Healthcare Systems.

. Experience in developing and analyzing Functional and User Requirement

Specifications (FRS, URS), Standard Operating Procedure (SOPs) and

Remediation Plans. Documenting Software Defects according to SOPs.

. Excellent hands-on experience and knowledge of Food and Drug

Administration (FDA) regulations, particularly 21 CFR Part 11, GxPs

(GMP, GLP, cGMP, GCP), and qualification testing protocols (IQ, OQ,

PQ).

. Developed Test Plans and Test Scripts based on the Business

Requirements Specification, Functional Requirements and Design

document for the functionality, security, system, Regression,

Integration and user acceptance testing (UAT). Developed Traceability

Matrix and Validation Summary Reports.

. Software Testing and Documentation, Analysis of the Business

Requirements and Functional Requirements, Design Specifications.

Performed CAPA, Risk Assessment, GAP Analysis and GxP Criticality

Assessment.

. Experience in Manual and Automation Testing. Experience with HP tools

like QTP and Quality center. Involved in Defect Tracking and Defect

Management.

. Experience in testing Siebel CRM, Siebel SFA and Siebel Analytics

(OBIEE). Strong knowledge of Siebel application. Knowledge of ARISg.

. Knowledge of client/server and web-bases systems architecture,

database concepts.

. Quick learner with strong project management, analytical and

communication skills.

Technical Skills:

Validation Standards FDA regulations, 21 CFR Part 11, cGMP,

GAMP, ISO 9000 Standards

Web Technologies HTML, XML, JavaScript, VBScript, JSP

Web Servers Tomcat 3.3, Apache 1.3, IIS 5.0

Tools Documentum, Crystal reports, TrackWise,

Siebel CRM, Siebel Analytics(OBIEE), MS

Word, MS Excel, Outlook

RDBMS MS SQL Server 7.x/2000, MS Access

97/2000, Oracle

Operating System Windows NT 4.0/XP/2000/ME/95/98, Unix,

Sun Solaris 2.x

Programming Languages C, C++, JAVA, T-SQL, PL-SQL

Testing Tools WinRunner, TestDirector, HP QTP, HP

Quality Center

Education:

. Bachelor of Pharmacy, Kakatiya University, India.

Professional Experience:

Siemens Medical Solutions, PA

July'10 - Present

Validation/Siebel Tester

SFA (Siebel Sales Force Automation):

Siemens Healthcare is one of the first companies to bring together medical

imaging and therapy, laboratory diagnostics, and healthcare IT solutions

across the continuum of care - from prevention and early detection, to

diagnosis, therapy and ongoing care. The purpose of this project is to

validate their Sales Force application involving Siebel 7.8 stream of

enhancements which helps in managing their opportunities, quotes,

proposals, orders, accounts, sales forecast and product configuration.

Responsibilities:

. Elicit detailed SME requirement specification by interacting with

business Users.

. Developed Use Cases on analyzing Business Requirements.

. Designed Functional Specifications based on Business Requirements.

. Supported Iterative development process.

. Followed Agile Scrum methodology process in testing.

. Developed Test Plans and Test Scripts based on the Functional

Requirements in Quality Center. Also designed alternate workflows

based on the specifications.

. Developed Traceability between requirements, use cases and test

scripts in Quality Center.

. Executed the developed scripts and workflows documented manually

through Quality Center.

. Performed Functional and Regression Testing.

. Reported the defects identified in Quality Center.

. Interacted with Developers, Business Analysts and Users to help them

resolve the defects identified during testing.

. Involved in daily scrum meetings and updated the status on testing.

. Helped Users with User Acceptance Testing.

Environment: Windows XP, Siebel 8.0, Oracle 10g, Quality Center 9.2, MS-

Word, MS Power Point, MS-Excel.

RadPharm Inc, NJ

Sept'08 - May'10

Validation/Siebel Tester

CTMS (Oracle's Siebel CRM):

RadPharm is a leading imaging core lab, managing the complete imaging

segment of clinical trials for the global pharmaceutical, biotechnology and

medical device industries. The Project included validation of Oracle

application (client server), RadTrack v1.0 (COTS software, Siebel Clinical

v8.0), which in turn will replace their existing Workflow Management System

(WMS). Siebel Analytics (OBIEE) and Reporting will replace the Workflow

Management System (WMS) Reports current version.

Responsibilities:

. Worked with team members to understand the requirements and

implementation of RadTrack v1.0 system (Siebel v8.0).

. Followed SOPs and Validation Plan in carrying out different validation

activities.

. Involved in updating and analyzing Business and Functional

Requirements documents by directly interacting with users.

. Analyzed Systems Requirements Specification (SRS) and System Design

Specification (SDS), developed Test Plan, OQ Test scripts and

scenarios manually. Also dry runned existing Test Scripts. Prepared

Validation Summary Report.

. Ensured that all requirements are completely tested and involved in

preparing Traceability Matrix for those requirements.

. Executed OQ Test Scripts and Scenarios manually both for dry run and

formal testing.

. Bugs identified were documented by creating an Incident Report

manually. Involved in defect tracking and management through Bug

Tracker (Documentum eRoom).

. Created test data. Interpreted test results and implemented

innovative, effective and efficient test design solutions in a timely

manner. Interacted with 3rd party vendor.

. Involved in developing and updating OQ protocol documents to

accommodate the expanding features and functionality of the RadTrack

v1.0 system.

. Involved in preparing GxP Criticality Assessment Document, Change

Control Document, 21 CFR Part11 risk assessment and Validation Summary

Report.

. Developed and updated UAT Scripts manually based on the Business

Requirements.

. Performed Black box, Functional and Regression testing when necessary.

. Developed and executed OQ Test Scripts for Siebel Analytics and Audit

Trials.

. Attended weekly meetings with Validation team and also interacted with

Developers, Business Analyst, SME, Users and Information Systems

departments to help them resolve the bugs identified during execution.

Also reviewed other validation documents.

Environment: Windows XP, Siebel Clinical v8.0, Oracle Business Intelligence

Enterprise Edition 10.1(Siebel Analytics), Java, Oracle 11i, Oracle

Clinical, Documentum eRoom v7.4, MS-Word, MS-Excel.

AAI Pharma, NC Feb'08 - Aug'08

Validation Analyst/BA

CDMS (Clinical Data Management System):

AAIPharma is a biopharmaceutical company involved in the acquisition,

improvement, and marketing of branded medicines primarily in pain

management and critical care. The purpose of this project was to validate a

clinical data management system which helps in managing the clinical trial

data collected from different trials conducted across different geographic

units.

Responsibilities:

. Followed SOP's, Validation Plan and Change Control procedures.

Involved in preparing GxP Risk Assessment document, CAPA and

Validation Summary Report.

. Developed and analyzed the User Requirements, Functional Requirements

and Design documents by working with business users.

. Helped out in preparing Test Plan, IQ and OQ protocols. Prepared and

executed OQ and UAT test scripts manually for both dry run and formal

testing. Prepared summary reports. Helped users in executing UAT

scripts.

. Executed the generated test scripts and bugs identified were reported,

tracked and managed by creating Incident Reports. Performed Regression

Testing when necessary.

. Established traceability between the requirements and test scripts.

. Acted as lead to a team of 3 members. Helped in preparing User

Manuals. Developed SQL queries for creating and updating test data.

. Reviewed Validation deliverables for accuracy. Created test data for

script execution.

. Prepared Validation binders. Involved in Functional, Integration and

System testing.

. Attended weekly status meetings with Project management team and also

coordinated with SME, Users, Business Analyst, IS and QA departments

to develop validation procedures and get the validation documents

reviewed and approved.

Environment: Windows XP, Clintrial 4.6, Oracle 10g, Documentum, Visio, HP

QTP 9.2, HP Quality Center 9.2, MS-Word, MS-Excel.

MedPointe Pharmaceuticals, IL Mar'06 - Dec'07

Validation/Business Analyst

EDC/CDMS (Electronic Data Capture/ Clinical Data Management System):

This project provided an EDC/CDMS system to all of associated business

units and geographies over the course of several phases to support clinical

data collection (patient Information) and cater the same to management

needs of the clinical research organization.

Responsibilities:

. Followed SOPs and Validation Plan throughout validation process and

provided inputs.

. Prepared User and Functional Requirements Specification Document by

directly interacting with users. Analyzed Design documents for test

script preparation.

. Involved in preparing Test Plan and Operational Qualification Protocol

(OQ). Developed IQ,OQ, PQ Test Scripts and Scenarios based on FRS and

System Design Document. Executed the developed and existing scripts

for both dry run and formal testing. Created test data needed for

script execution.

. Performed System testing and documented results according to company's

SOP.

. Followed PQ test plan in preparing and executing PQ test scripts.

. Developed Validation Summary Report, Deviation Reports, Incident

Reports, Traceability Matrix and updated User Manuals. Performed Gap

Analysis and Data validation.

. Developed UAT Test Scripts manually and helped users in executing

them. Documented the defects identified. Also involved in defect

tracking and management.

. Responsible for ensuring that all documentation and procedures comply

with the FDA 21 CFR Part 11 Regulations. Involved in preparing 21 CFR

Part 11 Risk Assessment and Overall Risk Assessment document. Involved

in QA Audit.

. Extensive interaction with 3rd party vendor, IT, Users, SME, Business

Owners, and QA departments to develop and maintain validation

procedures and get the validation documents reviewed and approved.

Also reviewed executed test scripts and scenarios.

. Responsible for creation of Project Checklist / Task Plan, Conducting

Weekly Review meetings and sending Minutes of Meeting Report to all

the responsible persons.

Environment: Inform 4.0 and CIS (Phase Forward), Clintrial 4.4, Oracle 8i,

Documentum Smartspace 1.0.7, HP QTP 9.0, HP Quality Center 9.0, MS-Word, MS-

Excel, Windows XP.

Validation/QA Siebel Tester (Oracle's Siebel CRM, SFA):

The purpose of this project was to provide a system that enables collection

of all trial related data across all trials being conducted at various

business units and geographies. The project also included testing of Sales

Force application.

Responsibilities:

. Co-ordinated 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, Test Plan, Validation Summary

Report.

. Prepared Change Control, Overall Risk Assessment, 21 CFR Part 11 risk

assessment, GxP Criticality Assessment, Summary reports and Deviation

documents.

. Performed Regression Testing, System Testing, Functional Testing, Gap

Analysis, GxP Risk Assessment of the system. Created and maintained

test data for script execution.

. Worked with users to ensure that the UAT test scripts are accurate and

proper.

. Formulated OQ Protocol, OQ Test scripts and test scenarios after

having analyzed Business and Software Requirements and System Design

Specification. Reviewed and executed existing Test scripts. Also Dry

runned prepared test scripts and test scenarios.

. Developed Traceability Matrix to ensure testing of each and every

requirement.

. Created Incident Reports for defects identified in testing. Involved

in Defect tracking.

. Developed SQL queries for creating and updating test data.

. Provided guidance to a team of 4 members. Followed Change Control

Procedures. Involved in QA Auditing.

. 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.

Environment: Siebel Life-Sciences 7.5.3, Siebel eClinical, Oracle 8i,

Oracle Clinical, HP QTP 9.0, HP Quality Center 9.0, MS-Word, MS-Excel,

Visio, Windows XP.

Inspire Pharmaceuticals, NC Nov'04 -Feb'06

Validation Engineer

Inspire is a biopharmaceutical company involved in discovering, developing

and commercializing prescription pharmaceutical products for diseases in

the ophthalmic and respiratory/allergy areas. They intend to build and

commercialize a sustainable pipeline of innovative new treatments based on

their technical and scientific expertise. Trial System application in

particular helps manage the drug-trials process and dispense new treatments

to the market.

Responsibilities:

. Performed reviews of computer systems validation lifecycle, creation

and review of test procedures and process improvements.

. Participated in developing the Test Plan, CAPA and Validation Summary

Reports.

. Involved in updating IQ, OQ, PQ protocols. Prepared and executed OQ

and PQ test plans, test cases and summary reports. Created and

maintained test data.

. Involved in the complete QA Lifecycle activities like User Acceptance

Testing (UAT) and System Testing. Also performed Regression Testing.

. Followed change control procedures for making changes to the existing

systems.

. Followed Standard Operating Procedures (SOPs) in carrying out

validation activities.

. Used business requirements document, translated requirements into

system solutions and developed Test cases. Also prepared Traceability

Matrix.

. Interpreted Use cases and derived test cases from it.

. Developed and executed SQL queries for Back end testing.

. Followed Rational Unified Process (RUP) for software testing.

. Followed the company's SOPs in updating the Operational Qualification

(OQ) and Performance Qualification (PQ) Plans for the Trial system.

. Used WinRunner for generating automated test scripts to check certain

functionalities of the application.

. Generated and executed some OQ Automation scripts for Functional

testing and Regression testing using Win Runner.

. Documented Test results, Test analysis and Change Control during

Validation.

. Reported, tracked and managed the defects identified.

. Used TestDirector for Bug reporting, tracking and generating Test

Metrics.

Environment: Windows NT, SQL, SQL Server 2005, WinRunner, Test Director, MS-

Word, MS-Excel.

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