CSV Specialist

Validation Specialist

IT consultant who consistently delivers quality systems in compliance with GxP regulations for life science companies. Utilizes risk-based approach to cost effectively validate computer systems. Successfully manages remote testing teams. Expert in writing and reviewing SDLC documentation. Hands-on team player with excellent communication skills and significant international experience.

Certifications

EMC Cloud Infrastructure & Services (EMCCIS)

RAPS Regulatory Affairs Certification (RAC)

ITIL Foundations v3

APICS Production and Inventory Management (CPIM)

PMI Project Management Professional (PMP)

Skills Summary

Core Competencies

Computer System Validation (CSV) and Infrastructure Qualification

System Testing and Test Case Design

SDLC Documentation

Regulatory Compliance

ERP and ECM Systems

21 CFR Part 11, GxP

Team Leadership

Guidance & Methodologies

GAMP Risk-Based Approach, MHRA Data Integrity Guidance

PIC/S Good Practices for Computerized Systems

DIA TMF Reference Model

SDLC, Failure Mode Effects Analysis (FMEA)

Software

HP Quality Center, HP Application Lifecycle Management

Documentum Life Sciences Suite, SunSystems, QAD ERP,

MS Project, MS Visio, MS Office

Professional Experience

EMC Corporation, Life Sciences Consultant 2009 - Present

Provide quality and compliance services to life science companies. Served as test manager, validation lead, and quality and compliance lead for global pharmaceutical and medical device companies.

Validation / Testing Specialist – Documentum Life Sciences eTMF

Validation specialist and system test manager for a highly configured and customized implementation of the Documentum Life Sciences eTMF solution at a leading pharmaceutical company

Delivered a high-quality system with near-zero defect level in production

Developed overall test strategy aligning testing activities between system, interface, data migration, user acceptance and performance test streams

Managed off-shore test team responsible for functional, usability and exploratory testing

Developed test cases and executed tests using HP Application Lifecycle Management (ALM)

Quality and Compliance Lead – Infrastructure Build and Qualification

Quality and Compliance Lead on a team tasked with building, qualifying and deploying enterprise servers and storage infrastructure.

Developed the qualification strategy for the migration of storage from NetApp to EMC infrastructure

Ensured virtualized SAP servers and storage infrastructure were built and qualified in compliance with client’s quality management system

Trained the team on client procedures and enforced compliance

Test Manager – JDE EnterpriseOne ERP

Managed multi-site, cross-functional integrated testing activities as part of a project to integrate two business units into a highly customized JDE EnterpriseOne ERP system.

Developed guidance and delivered training for the use of HP Quality Center to manage the testing process

Coordinated testing process, including defect management and stress testing

Managed off-shore team responsible for test script automation using HP QTP

Short Road Consulting, Business Owner and Independent Consultant 2001 - 2009

Provided CSV, business analysis and system testing services to life science companies.

CSV Lead – Inventory / Distribution System

Devised and implemented a cost effective program to validate a global pharmaceutical’s distribution system in 30 sites worldwide.

All sites successfully completed validation activities during initial system implementation

Maintained system’s validated state through two major upgrades

Used risk-based methodology to focus work on critical functions

Leveraged OQ testing at the corporate level and developed documentation templates and job aids to minimize work at individual sites

Delivered on-site, multi-day workshops in Europe, Latin America, Asia and Africa to train local implementation teams

Authored business requirements, functional specifications and IQ / OQ / PQ protocols

CSV Lead – ERP System

Achieved successful validation of API manufacturer’s ERP system.

Identified and eliminated Part 11 Electronic Record and Electronic Signature (ERES) compliance gaps

Performed FMEA risk analysis to identify and mitigate risks

Developed validation plan, user requirements and functional specifications

Provided guidance on software configuration to ensure GxP compliance

Business Analyst

Served as Business Analyst on various internal software development projects

Worked with business experts to streamline business processes and formulate user requirements

Authored requirements and functional specification documents

Developed test plan and oversaw testing

Wrote software documentation, including user manuals, installation instructions and release notes

Taratec Development Corporation, CSV Consultant 2000 - 2001

Validated ARISg adverse drug event and reporting software for a pharmaceutical company

Provided quality assurance / validation guidance to a desktop engineering team moving workstation applications to a new desktop image as part of O/S upgrade

Arbour Group, LLC, ERP Systems Implementation Consultant 1995 - 2000

Implemented MFG/PRO ERP systems for pharmaceutical and biot

echnology companies

Produced validation test scripts sold as a companion product to life science companies implementing QAD’s MFG/PRO ERP application

Ethicon, Inc., a Johnson & Johnson Company, National Planning Systems Manager 1985 - 1995

Business owner of ERP system used for production planning, manufacturing and cost accounting

Key member of team that reengineered supply chain processes and implemented ERP system in 6 sites nationwide

Education

Penn State University, State College, PA – BS (Industrial Engineering)

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