SUMMARY:

• Over 6 years Pharmaceutical experience including Validation Services Manager, Compliance (GxP & 21 CFR Part 11, 21 CFR Part 820), Quality Assurance, Computer & Process Validation (SDLC) Remediation, Audits, Operational Quality Review, Technical Writing.
• Strong IT and Quality Assurance experience since 1988.
• Courses in FDA Regulations, ICH Guidelines, GCP, Compliance
• Strong knowledge of eCTDs, INDs, NDAs.
• Strong experience in Computer Systems Validation / Technical Writing to ensure compliance to 21 CFR Part 11, Part58, Part210 and FDA regulations in the Pharmaceutical industry.
• Strong knowledge of SDLC (Software Development Life Cycle) methodologies and implementation of various COTs and Legacy Systems.
• Authored and provided training for courses on 21 CFR Part 11 and Common Technical Document (CTD), CSV Basic Fundamentals, GAMP4/5
• Hands on Experience in creating full set of documentation involved in Validation Life Cycle.
• Including, User Requirements Specification, Design and Configuration Specifications, Master Qualification Plan, IQ/OQ/PQ Plan, Scripts and Summary Reports, SOPs.
• Involved in Change Control Management, Performed Risk Assessment, Technical Impact Assessment and Business Impact Assessment.
• Strong knowledge in performing GAP Analysis and creating Remediation Plan.
• Strong knowledge and understanding of the Internal QA Audits.
• Excellent Analytical, Technical, Organizational and Project Management Skills with Excellent written and verbal communication skills.

• Documentum/LiveLink/FirstDoc/MS Sharepoint/IBMScore
• Kofax
• Plateau
• PVCS, Visual SourceSafe
• MS SQL/Oracle 9i-10g
• PhaseForward ClinTrial, PKS, WinNonLin
• Linux
• Citrix, VMWare ESX Server and Workstation
• Microsoft Word, Excel, PowerPoint, VConfidentialo, Outlook, Access
• SAP
• Windows 2000/XP/Vista/Windows 2003 Server
• SpiraTest, WinRunner, Quick Test Pro,
• .NET and Java Technologies
• SAS
• SalesForce
• Other in-house and COTS applications

• Bilingual: Spanish/English
• Certified Network Administrator, CNE (1996)
• Microsoft Product Specialist (1997)
• MCSE, 1999
• DIA Member
• PMP Certification – In Progress

EDUCATION: 

Bachelor of Business Administration- Management Information Systems

EXPERIENCE:

CONFIDENTIAL, Whippany, NJ 05/07 - Present
Regulatory Validation Manager, Global Services

Manage a team of 11 validation specialists. Strong Testing Methodology, GAMP and Risk Based processes and validation. Define and scope each project and provide communication through out the project life cycle. Coordinate validation activities with business managers and validation resources. Resolve or escalate client issues. Communicate status of project with client, team, peers and leadership currently in progress. Define process risks and suggest mitigation approaches. Monitor process activities for risk and take timely action. Advise project team members, business team and senior management of actions required. Resolve problems by analyzing root causes, discerning the most appropriate course of action, providing tactical direction and reallocating resources. Involved in opening CAPAs to document and remediate processes in Work Instructions and SOPs. In depth knowledge of paper and electronic submissions. Directly involved in pre-sales, kickoff meetings, SOW, creating budgets and forecasting resource utilization. Strong knowledge in Test Automation, Test Management, Defect Testing, Performance Testing. Hands-on experience with validation prototocl development (MVP, TP, SDS, FRS, URS, IQ/OQ/PQ, VSR, TM, etc.).

Confidential, Ridgefield Park, NJ 05/04 – 05/07
QA Migration Project Lead Analyst

Provide hands-on leadership to team of 5-10 support members. Develop, maintain and update XP Migration Project Plan including Discovery, Build, Packaging, Testing, Documentation and Validation. Develop and Implement Application Packaging Standards, Operations Guide and Procedures. Designed and implemented packaging standards and delivery method which reduced system build time by 50%, while ensuring licensing compliance and uniformity. Coordinate resources for all phases of the XP Migration Project. Provide ongoing support for all phases of project plan. Continue to provide daily support for XP Build. Responsible for all phases of Application Integration for XP Build including Requirements Definition, Packaging, UAT, QA, Validation, Deployment and Support. Proven experience in computer systems validation and automated testing, with particular knowledge of 21 CFR Part 11. Project Management responsibilities include implementation of global LMS project, Phaseforward ClinTrial, WinNonLin, EDMS, Documentum, Annodoc, CONFIDENTIALToolBox, PKS, regional Desktop upgrade and deployment project, application packaging project, validation remediation project. Develop business and practical processes and policies relating to procurement, asset management and system validation. Develop engineering processes and policies regarding system images, deployment of images, maintenance and refreshes of images. Managed clinical systems and interacted with Clinical Data Managers, Oncology, CRO’s and CRFs.

Confidential, New York, New York
Project Lead Engineer (Consultant) 11/01 – 05/04

Provide Hands-On leadership for 10 consultants with various tasks for the Onedesk Migration Project. Expertise in testing complex application interfaces, as well as the entire life cycle of development. Diagnose problems associated with application software as well as the infrastructure the applications are running on in production. Expertise in all core and line of business applications that have been integrated using WISE (MSI), including core model builds, hardware upgrades, service packs, patches, etc. Designed and created test scripts, QA checklists, and error reporting standards and procedures. Thorough knowledge of MS Windows NT/2000/XP, Novell, Active Directory, SMS and Zenworks. In-depth knowledge of TCP/IP, client-server applications SQL, Oracle, Sybase, etc. Responsible for scheduling User Acceptance Testing of applications to ensure their appropriate functionality and creating verification scripts. Utilize various tools for capturing errors, such as Veritest Analyzer and VMWare. Coordinate resources for all facets of application integration to ensure migration deadlines are met. Setup weekly staff meetings to discuss issues, standards, policies, changes, etc. Provide “Day One” support after migration to Onedesk. Manage issue resolution with development staff. Excellent analytical and problem solving skills. Excellent team player. Responsible for updating intranet with latest standards and procedures. Maintain and organize internal QA test environment.
Confidential, New York, NY 2/00 – 11/01

Provided weekend support for mixed environment consisting of NT, Novell 4.11, AS/400. Supported mirrored environment for Novell 4.11 with DoubleTake. Setup DLT HPSureStore Backup for NT and Novell servers. Provided weekend support for users. Implemented and maintain Anti-Virus solution on servers using Inoculan for Novell and Norton Antivirus for NT. Setup and configured Novell 5.1 and Windows 2000 in a development lab as preliminary work for migration project.

Confidential, Lyndhurst, NJ 6/99 – 2/00

Participated in Y2K Core Remediation Project which entailed building, upgrading, migrating and patching servers including Novell Netware 3.11, 3.12, 4.10, 4.11 and Windows NT Server 3.5 and 4.0. Performed server migrations from 3.12 to NT 4.0 Cluster Server Farm. Assisted IBM Team and local administrators with ClickNet Reports of all servers detailing Non-Y2K components.

Confidential, New York, New York
NETWORK ENGINEER 2/98 – 6/99

Manage Quality and Integration Testing for Chase Connect 2000 project consisting of 8 consultants for multiple clients, including full project scope. Build, install and configure both NT 4.0 and Novell 4.11 servers in an isolated development lab to mirror production environment for Y2K testing. Quality & Integration testing of applications, desktops, laptops, and servers. Tested and made some important recommendations for the following: NDS infrastructure with NAL 2.6 and Z.E.N, NT Domain policies with group priorities, Windows 95 Laptop build, NT desktop build with Novell Client 4.30.410, and Chase in-house applications.

Confidential, New York, New York
SERVER ENGINEER 2/96 - 2/98

Server Support - Provide primary server support for 65 Novell 3.x and 4.x servers. Perform system assessments and provide recommendations for upgrades and new installs. Build, test and implement production and development Novell and NT servers using Compaq Proliant 5000/6500, RAID Level 5, duplex and mirrored environments providing different level of Fault Tolerance. Responsible for implement backup schemes using Arcserve 6.1 for Netware.

Desktop Support - Provide primary desktop and server support for 200 users in the Audit Department using Novell 3.1x and SFT III, Windows NT Workstation 3.51/4.0, Netware for SAA, Lotus Notes, in a Token Ring environment. Responsible for designing and deploying over 100 Toshiba Laptops to replace existing hardware. Design and implement MS NT Workstation 4.0 environment for 2000 users. Responsible for all project management. Responsible for ensuring Daily Backups and Virus protection procedures are maintained. Provide regular network administration support duties utilizing network management tools i.e., Lananalyzer and reporting tools such as Bindview to provide an accurate set of management reports. Responsible for TCP/IP addressing and Netscape implementation. Responsible for designing and installing a testing environment with Windows NT Server 3.51 and Windows NT Workstation for power users in the Audit Department.

Confidential, Orlando, Florida 10/95 - 1/96
NETWORK ENGINEER - 4 month contract

Provided day to day PC/LAN/WAN Level III support for 7,000 PCs and 150 Novell 3.x - 4.1 servers including installation and configuration of hardware and software on workstations and server, adding users, print services, adding HP JetDirect cards, patching workstation positions in the LAN closet, resetting Synoptic hubs and routers, adding Synoptic host modules. Installed and configured backup tape units. Installed Uninterruptible Power Supplies. Installed and configured Irma for Windows to access AS/400, InfoConnect for Windows to access UNISYS system via TCP/IP, Netware for SAA to access MVS system on workstations. Installed and configured workstations with Netscape to access the Internet with TCP/IP (BOOTP), NETX, VLM\'s. Assisted in the migration of pilot group from MS Windows 3.11 to Windows 95. Installed, configured and provided extensive email support with cc:Mail for Windows, DOS, Mac, Remote and Mobile users. Provided daily support for 35 Macintosh\'s using AppleTalk, EtherTalk, and TokenTalk including installation and configuration of hardware and software in local and network environment, adding and sharing printers, users, files and applications.

Confidential, New York, New York 6/95 -10/95
APPLICATION SPECIALIST - 4 month contract

Designed, installed and configured a DB2/2 server in a client/server development environment using OS/2. Installed and configured Micro Focus Cobol, DB2/2, and DDCS/2 to access data on the server and directly from the mainframe using OS/2, Communication Manager/2, LAPS, and Netware Requester for OS/2. Installed and configured Windows for Workgroups on the workstation connecting to a Windows NT server. Provided daily administration of 15 users on Windows NT by creating ids, changing profiles, passwords, domains, etc. Installed and configured PowerBuilder Enterprise 4.0, Visual Basic on workstations.

Confidential, New York, New York 10/94 - 6/95
SENIOR LAN ADMINISTRATOR

Installed and configured workstations, file and print servers using IPX/ODI, VLMs, OS/2, and windows applications for 1000 LAN/WAN Novell users (v3.11, 3.12). Provided daily troubleshooting of problems involving hardware/software installation and upgrades. Installed and maintained client/server development software including MicroFocus Cobol platform, XDB, PVCS, DB2/2, PowerBuilder Enterprise 4.0 (Windows and OS/2 using WATCOM), Visual Basic, Borland C++, Attachmate/Extra for Windows. Responsible for maintaining 8 Compaq Proliant servers using SFT Level III and tape backups in LAN/WAN environment including installing and configuring users, printers, software, hardware. System administration of IBM/6000 including adding users, changing passwords, installation and configuration of hardware/software through SMITTY and XWINDOWS. Responsible for backups and maintenance of DirectTalk and Sybase data on AIX.

Confidential, New York, New York 1/91 - 10/94
LAN ADMINISTRATOR

Responsible for installing, configuring, and supporting hardware/software on a 150 node Novell Local Area Network. Developed LAN Disaster Recovery Plan, Hardware/Software Policy, and LAN Procedures. Upgraded software including Novell Netware 3.11, Castelle Fax Server, WordPerfect Office 3.1, Cheyanne Arcserve Backup. In charge of founding Computer Help Desk including monthly Newsletter which provided daily support to all users including extensive support for AS400 and MicroVax 3900, installing hardware and software, adding users, printers, changing passwords, configuration of workstations. Designed, wrote and conducted training sessions at all levels of employment in WordPerfect 5.1, Lotus 123 2.4, Harvard Graphics, Windows 3.1, and other financial systems. Research, evaluate, purchase, configure and install computer hardware and software on workstations, LAN, VAX. Plan yearly budget for hardware and software accounts. Responsible for the supervConfidentialon of the night operator.

Confidential, New York, New York 10/88 - 3/91
LAN SUPPORT (9/90 - 3/91) - TECHNICAL SUPPORT (10/88 - 9/90)

Held lead support position during the installation of a 1600 node network entailing moves, installations and configurations of workstations. Assisted in the conversion of 85,000 documents from an in-house management systemto PerfectSolution 2.0. Maintained the PC-LAN to System 38 connectivity. Provided Support for Novell Netware 386 version 3.10. Assisted in System Administrative using SYSCON and PCONSOLE. Designed, wrote, tested, and documented PC applications using Dbase III+ and Clipper. Conducted extensive training sessions in WordPerfect 5.0 and In-House network software (AS400), Lotus 1-2-3, Dbase III+, and other software applications.