Management System

SUMMARY

. Over * years of experience in a variety of computer platforms in all

phases of SDLC (full-life cycle) through Implementation/Maintenance

. Experience with Computer Systems Validation (CSV) including drafting

Requirements (URS/ FRS), Design Reviews, Risk Assessments, Validation

Plans and Protocols for Installation Qualification (IQ), Operational

Qualification, Performance Qualification (PQ), Test Plan Protocol

(TPP), Validation Summary Report (VSR)

. Experience in Quality Assurance, Regulatory Compliance, Deviation

Management, Quality Control, Product Development and Technology Transfer

. Expert in CSV. Managed a wide array of validation projects in the GLP,

GCP, GMP, QSR realms.

. Deep IT Infrastructure Compliance expertise. Establishing Validation

Methodologies, Templates and Standards.

. Managed and executed several Business Process Automation projects

using ECM (Enterprise Content Management), Crystal Reports, MS

SharePoint. Closing Audit Gaps and completing Capes pertaining to

system and procedural non-conformance.

. Led Risk Assessments.

. Well versed in GAMP.

. Good understanding of LIMS.

. Deep expertise in Change Control.

o Established Change Control procedures and processes

o Established Change Control and configuration management

. Expert on 21 CFR Part 11. Spearheaded risk based approaches to 21CFR

Part 11. Worked with several vendors to ensure their system meets Part

11 compliance scrutiny..

. Excellent interpersonal, organizational, verbal and written

communication skills.

SKILLS PROFILE

Programming Languages: SQL, PL/SQL, Transact SQL, JavaScript, VBA,

HTML, Assembler, C

Application Development Tools: Livelink 9.7 and prior, Documentum, Cognos

Finance Application, C Compiler, Crystal Reports

Databases / DB Tools: Oracle 10g (and earlier), Sybase 11.x, TOAD,

SQL*Plus

Operating Systems: Windows NT, Windows 2003 (and earlier)

SCM: Visual Source Safe, Remedy, Magic,

Clearcase/Clearquest, TrackWise

TeamAccess-6.0

TRAININGS

. Attended Deviation Management, Problem Reporting and Corrective Action

courses

. Attended SDLC (Software Development Life Cycle) and CSV (Computer

System Validation), Computerized System Validation Deviations courses

. Attended Electronic Records and Electronic Signatures (ERES): Basic

Part 11 Awareness

. Attended Electronic Records and Electronic Signatures (ERES): Advanced

Principles and FDA Guidelines

PROFESSIONAL EXPERIENCE

Genentech (South San Francisco, CA)

Validation Engineer (Mar 2009- April 2010)

Served as Validation lead for key applications such as POMS, Livelink EDMS,

Trackwise, NovaManage, MES 5.1, BRES, and BAHR. Accomplishments include:

. Actively involved in Maintenance and Enhancement of Trackwise, gPOMS,

BRES-Crystal Reports, Livelink EDMS system (Workflows) including

execution of patches (as IQ) and preparation of Risk Assessment,

Traceability Matrix and Final Summary Reports.

. Lead the validation team through all the validation activities for

Livelink and Trackwise systems.

. Validated the efforts of migrating Novamanage data into Livelink

environment

. Worked as IT Rep for review and closure of items (non-conformance

reports) during Quality Board Review.

. Completed audits with internal and external auditors to ensure IT

compliance.

. Responsible for Quality review (Validation Documents) and preparation

of Validation Summary Report for Various GMP applications-Livelink,

gPOMS, BRES and BAHR

. Arranged QA and CAPA related trainings.

. Involved in preparing and updating Validation deliverables for LIMS.

. Involved in authoring VPP, IQ/OQ Protocol, Risk Assessment, Trace

Matrix, Authoring Summary Report for migration and enhancement

activities of Livelink EDMS System.

InterMune Inc. (Brisbane, CA)

Validation Lead (Jan 2008 - Feb 2009)

InterMune, Inc. is a biotechnology company focused on developing innovative

therapies in pulmonology and hepatology. Coming from a legacy Hummingbird

environment, assisted in assimilating into a robust Documentum environment

in accordance with FDA standards. Accomplishments include:

. Developed the validation document templates and procedures including

SDLC methodologies and IT Standard Operating Procedures (SOPs) for

System Maintenance and Backup/ Recovery processes.

. Established the Change Control procedures and policies for in-house

projects.

. Responsible for preparing VMP, IQ/OQ/PQ protocols and validation

summary documents.

. Reviewed, updated and organized documents prior to Quality Review with

respect to documentation practices.

. Develop all the required documentation, including System Requirement

Specifications, Functional Design Specifications, Risk Analysis,

Traceability Matrix, Operational Qualifications (OQ), Performance

Qualifications (PQ) and other supporting documents for validation of

Documentum EDMS.

. Develop, Maintain and track validation plans and summary reports.

. Involved in migration and validation of Hummingbird data into

Documentum environment

. Developed and wrote test cases for the testing efforts in compliance

with the rules and regulations of FDA 21 CFR Part 11 (Electronic

Records and Electronic Signatures)

Quintiles Inc. (Morrisville,NC) Validation

Consultant (Jan 2006 - Nov 2007)

Served as Validation lead for key Livelink based application. EDMS,

Livelink is used in Quintiles as a tool for Knowledge Management and

Document Management. Enterprise Document Management System (EDMS) is

visualized, designed and implemented to automate the different processes.

The system can be accessed anywhere across the Quintile's internal network.

Accomplishments include:

. Developed User Requirement Specifications (URS), Functional

Specifications (FS), Risk Analysis (RA), Traceability Matrix,

Operational Qualifications (OQ), Performance Qualifications (PQ) and

other supporting documents for validation of livelink EDMS system

. Performed the Risk Analysis for the EDMS system.

. Involved in Vendor presentations and prototypes for various Document

Management Solutions. Worked with vendors to ensure systems are 21 CFR

Part 11 compliance.

. Executed the OQs and PQs in QA and PROD environment

. Generated validation protocols, use and maintenance of SOPs

. Develop, maintain and track validation plan

. Analyzed and Configured different Modules ( Directory Services,

Livelink Explorer, e-Sign etc.) as per the business requirements

GE Finance. (Atlanta,GA) Consultant (Jul

2003 -Dec 2005)

Served as Livelink Administration for the Collaboration System based on the

Livelink from Open Text. Collaboration System helps to organize the

information and enables teams to share information, to work together, to

plan together and make better decisions. Accomplishments include:

. Participated in discussions and presentations from different business

units to understand the business needs and provide solutions

(including Infrastructure Prerequisites, Installation Process

Overviews etc.)

. Installed, Configured and maintained the Collaboration System (using 3

tier tri-server architecture)

. Involved in setting up of Security modeling and Performance, Tuning of

the Collaboration System

. Served as an Livelink Administrator in performing functions such as

managing Livelink system, assigning access privilege, administrating

Users & Groups, administrating Project Workspaces, attributes,

categories and auditing, monitoring and purging Livelink log files,

installing recent patches etc.

. Designed, Developed Reports used for Business Managers as per

requirements

Environment: Livelink 9.5, Meeting Zone2.1.1, Directory Services2.3.1,

Oracle 9i, Live Reports

Served as a member of technical support team for the Finance Application

using Cognos Finance and BI tool. Business Analysts prepare short-term

estimates, Operating Plans, and Long Term Budgets for nine legal

entities. Information is input, validated and consolidated for corporate

system. Accomplishments include:

. Involved in the maintenance and support of the Cognos Finance

Application.

. Develop and Maintain Cognos Finance libraries, dimensions, Inputs, and

Reports.

. Administration of Cognos Finance including define item; maintain

submission, calc submission, file processing, Metadata exchange and

security module.

. Defining security and access for users and user classes thru Access

Manager.

. Design the security layer on top of application to enable Single Sign

On for Cognos Web.

UNITED SIKHS (NY, NY) Developer (Jan 2003 -

Aug 2003)

UNITED SIKHS is an international non-profit, non-governmental, humanitarian

relief, human development and advocacy organization, aimed at empowering

those in need, especially disadvantaged and minority communities across the

world. Donation Management is used to collects donations from different

sources under various welfare programs. This project involved the

development of a computerized system to monitor the management, budgeting

and analysis of these funds.

Environment: MS Access, HTML, Java Scripts

Tata InfoTech Limited. (India) Engineer (Jan

2002 - Oct 2002)

The project was developed for The Motor Transport Organization (MTO) of the

Indian Navy. MTO allocates vehicles according to user request and

availability. Participated in design and development of the system,

implementation and documentation.

Environment: PowerBuilder 5.0, Oracle 7.3, PFC

Additional Technical Trainings:

. Livelink system administration

. Designing and developing Forms

. Designing Workflows I,II,III

. Troubleshooting and supporting your Livelink system

Contact this candidate