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Project Manager

Location:
7014, United States
Posted:
May 27, 2010

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****** *******

(973) ***-**** ( ********@*****.***

SUMMARY: Masters in Information Systems from Stevens Institute of

Technology. Resourceful and highly skilled professional with diverse

experience in the Healthcare and Information Systems. Major strengths

include business knowledge, problem analysis and solving, effective

communication, ability to work well with diverse groups of people,

planning/organization efficiency.

. 8 years information systems experience in structured software development

and implementations using Software Development Life Cycle methodology.

. 8 years experience in testing / validation of computer system

applications, understanding of FDA regulations

. 8 years experience in software configuration and support in

regulated environment.

EXPERIENCE: Merck

01/ 10 - Present

Project Lead (Consulting Assignment)

Manage and lead the implementation effort on TrackWise Global Customer

Complaints. Responsibilities include:

. Conduct prototype and design review sessions with business

representatives.

. Work with the QA/ Validation teams to successfully validate implemented

systems.

Bristol Myers Squibb Co.

07/ 05 - 01/10

Project Implementation Lead (Consulting Assignment)

Managed and led the development effort on over ten Trackwise

Implementations across Global Business Units within the "TrackWise Center

of Excellence (COE)" at Bristol Myers Squibb Co. Projects included

tracking EMEA BCF & Compliance, CAPAs, Product Recalls, Government

Inspections/Interactions, SRC/SAP/NDC Material Tracking System, Global

Quality and Regulatory Compliance Audit Tracking (GQRC) - GLP & GCP, 3rd

Party Mfg. Tracking, Waste Vendor Tracking & Actions Tracking.

Responsibilities include:

. Responsible for project cost estimation, project resource tracking and

project timelines.

. Oversaw teams and developed/configured projects from end to end in

validated and non validated environments.

. Facilitated business teams in establishing global business processes and

in defining system requirements.

. Conducted prototype and design review sessions with various business

client representatives to help with business process evaluation.

. Coordinated with the QA/ Validation teams to successfully validate

implemented systems.

. Ensured that all work is conducted in accordance with corporate

standards, SOPs and guidelines pertaining to Computer Systems Validation,

Good Documentation Practices.

. Responsible for project cost estimation, project resource tracking and

project timelines for Global Projects in excess of $500,000.

Cardinal Health, Piscataway, NJ

10/04 - 07/05

Global Lead

Led the development & implementation of Global Quality Tracking System

(GQT) in TrackWise 6.0 for 15 workflows across 25 global sites. This was

a 21 CFR Part 11 compliant system for Cardinal Health's Supply Chain

business geared towards delivering regulatory solutions to critical

business functions, such as, Regulatory, Sterile & Oral Technologies,

Packaging Services and Pharmaceutical Distribution. Responsibilities

included:

. Facilitated design review sessions as required, and ensured that

Corporate SOPs and methodologies are strictly adhered to.

. Developed System Design Specification documents and Installation

Qualification protocols for each application. Reviewed Validation Plans,

Summary Reports, Traceability Matrix OQs / PQs.

. Prepared General System Use, Local System Administration and Global

Administration SOPs for GQT.

Schering-Plough Research Institute, Kenilworth, NJ

05/03 - 10/04

Sr. Systems Analyst

. Provided regulatory compliance support services to the business and IT

groups to validate and implement Documentum's GxPharma, a cGMP, cGLP,

cGCP, and 21 CFR Part 11 compliant system. GxPharma was designed to

manage the control of documents using document lifecycle and workflow

automation and will provide SPRI with a secure document management

environment to manage and control SOPs, lab procedures, guidelines and

other related documents throughout their lifecycle. Responsibilities

included:

> Worked with vendor to develop validation documentation including User

and Functional Requirements Specification, Testing Plans, scripts,

summary reports.

> Assisted in developing Installation/Operational Qualification

Documents for each validated environment.

> Managed and coordinated the System and Integration testing and

assisted in Performance Qualification/User Acceptance Testing.

. Part-time Project management for the report validation initiative for

Schering-Plough's Pharmacovigilance CAPA project. This effort involved

leveraging the Periodic Safety Update Reports (PSUR) generation to create

product lists and definitions for 60 products reported to the EMEA as per

the company's CAPA commitment. Responsibilities included detailed

analysis of the report requests from the user groups, checking for

technical/GDP completeness, assigning report development and coordinating

between 9 developers, 3 Operational Quality Reviewers and the business.

. Assisted with implementing Global Applications Change Control System

(GACCS) using TrackWise 6.0, to meet the SOX Objectives for tracking the

changes made to the financial systems in SOX inventory within the Global

Pharmaceutical Business Unit of Schering-Plough. Responsibilities

included architecture, configuration, project coordination, and

client/vendor liaison.

Schering-Plough Research Institute, Kenilworth, NJ

05/01 - 04/03

Applications Analyst

. Assisted with the development & implementation of Labeling Tracking

System (LTS) and Global Regulatory Affairs Commitment Tracking System

(GRA CTS), both 21 CFR Part 11 Tracking Systems, using TrackWise .

Responsibilities included architecture, configuration, project

coordination, and client/vendor liaison.

. Led the testing team during System, integration and Regression testing.

Intern / Tester

. Developed and executed test scripts for Functional, System Integration,

and Regression testing for SPRIDox V4 & Regulatory Document Management

System (RDMS), both Documentum applications.

. Recorded and tracked defects using Rational's SQA Manager Software tool.

All work performed in compliance with applicable GLP and GMP FDA

regulations.

EDUCATION: Stevens Institute of Technology, Hoboken NJ

Masters in Information Systems, Major: Computer Science

May 2002

Maharaja Sayajirao University, India

Bachelor of Science, Major: Mechanical Engineering

June 1998

OPERATING SYSTEMS AND SOFTWARES:

. Windows 9x/NT/2000/XP; MS Office 97/2000/XP; HTML, SQL Sever 2000, SQA

Manager

. TrackWise Software - TrackWise TeamAccess , TrackWise Administrator,

TrackWise Coordinator, TrackWise Migrator, Crystal Reports

. Documentum Software - GXPharma (Web and Docbase Components), Documentum

Administrator 4.3

. Publishing Software - CoreDossier Administrator, CoreDossier Assembler,

CoreDossier Generator/Server

CERTIFICATIONS & TRAINING:

. Project Management Principles

. Systems Development Life Cycle

. 21 CFR Part 11 Awareness Training / Applied Training

. Computer Systems Validation / Good Documentation Practices

. SOP Awareness Training

. FDA Inspection & Audits

. Basic Drug Development

. Certified TrackWise Administrator / Coordinator

. Certified CoreDossier Administrator 5.5.x / Publisher



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