CSV Specialist

Objective:

To obtain a permanent or contractor position in the Computer System Validation or Computer System Assurance fields in a company where I can expand my knowledge and contribute to the growth of the company.

Summary of qualifications:

•Experience with the computer system validation of the following software:

oSAP versions 8.0, 9.0, 10.0, 11.0, 12.0

oISOtrain version 5.2.6

oManufacturing Document Management (MDM) version 5.3.x

oMSC Payroll version 4L 8.0

oMerit Tool version 2.1

oTrackWise version 6.0, 7.0

oCycle Count

oMMII

oFAMS (Fixed Assets Management System)

oADP

•Experience with the Qualification of the following Servers:

oHewlett Packard ProLiant DL385 G1

oHewlett Packard ProLiant DL585 G1

•Experience with the Qualification of the following Switches:

oCisco Catalyst 3750-24

oCisco Catalyst 4506

•Experience with the Qualification of the following RF Devices:

oIntermec Antares 24xx Series

oIntermec 700 Color Series

•Created one or more of the following validation documents for the software, servers or switches mentioned above:

oValidation Plan

oQualification Plan

oRoles and Responsibilities

oSystem Overview

oUser Requirements Specifications

oRequirement Definitions

oPackage Configuration

oTest Plan

oTest Scripts

oTest Summary Report

oTraceability Matrix

oBusiness Continuity Plan

oTraining Plan

oSecurity Plan

oSecurity Administration Standard Operating Procedure

oBackup and Restore Standard Operating Procedure

oBusiness Standard Operating Procedure

oRetirement Plan

oChange Controls

oTechnical Specifications

oInstallation Qualification Protocol(and execution)

oOperational Qualification Protocol (and execution)

oPerformance Qualification Protocol (and execution)

oQualification Protocol and Summary

oValidation Report

•Experience with Applications:

oMicrosoft Word, Excel, Power Point, Visio, Project

oWindows 95, 98, 2000, ME, XP

oInternet Explorer

oDocumentum

oAction Request System (Remedy)

oTest Director 8.0

oISOTrain

•Experience with Computer Systems Quality Policies and Procedure, Good Manufacturing Practices and 21 CFR Parts 210 and 211.

•Strong communications and interpersonal skills

•Function well in a group or collaborative effort

•Ability to self-manage multiple concurrent projects and deadlines

•Work independently, manage time, and complete tasks with minimum supervision

Experience:

Aug 2006-Present/BE&K BioPharm/Guaynabo, PR

Computer Systems Validation Specialist

Consulting Projects:

oMay 2008-Jan 2009

Banner Pharmacap

High Point/North Carolina, USA

Validation Specialist

TrackWise 7.0 global implementation. The implementation included USA, Mexico, Canada and The Netherlands.

oNov 2008

Organon

Durham/North Carolina, USA

Qualification Specialist

Support the commissioning activities

HVAC to BMS Input and Output verification

oJan 2007-May 2008

Lifescan

Cabo Rojo/Aguadilla, PR

Qualification Specialist

Support to the NCS PR Department

Server Qualification

Switch Qualification

oSep 2006-Dec 2006

McNeil Consumer HealthCare

Las Piedras, PR

Qualification Specialist

Support to the NCS PR Department

Server Qualification

May-2006-Aug-2006/GlaxoSmithKline/Cidra, PR

IT Specialist

Supports the IT Remediation Team in the Computer System Validation activities.

Jun-2002-May-2006/Lilly del Caribe, Inc/Carolina, PR

Validation Consultant/Coordinator

Validation Consultant for the implementation project team members

Working in the Local IT Validation Team of the Global Project implementing SAP. Responsibilities include the development (writing, revision, approval) of Validation Packages according to the local or corporate Computer Systems Quality Policies and Procedures

Validation Librarian

Validation Support / Consultant for the IT Department

SOP Coordinator

Testing Coordinator

Training Coordinator/Instructor/Writer

Language:

Bilingual - fluent at reading, writing, and speaking both English and Spanish.

Education:

2007 - Present/Polytechnic University of Puerto Rico/Hato Rey, PR

BS in Computer Engineering – In Progress

1995 - 2002/University of Puerto Rico/Mayagüez, PR

BS in Computer Sciences

1992 – 1995/Ramón José Dávila High School/Coamo, PR

High School Diploma

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