Sample Template Example of Beautiful Excellent Professional Curriculum Vitae / Resume / CV Format with Career Objective, Job Profile & Work Experience for Freshers & Experienced in Word / Doc / Pdf Free Download
Validation Engineer
Download Resume Format
MARRY MOLDAVSKY
115 Presidential Blvd - #
539
BalaCynwyd PA 19048
(610) 225-5866
marrym@yahoo.com
SUMMARY
OF COMPUTER SYSTEMS VALIDATION EXPERIENCE
·
MS in Computer Science and 20 years of pharmaceutical experience.
·
10 years of experience in the
following areas of Computer SystemValidation: Document Management Systems, Training
Management Systems, Sales Force Automation,Drug Samples Transactionsand Product
Complaint Handling, Regulatory Affairs Information Systems and Medical Imaging
Systems.
·
5 years of experience in the validation and technical support of Documentum.
·
5 years of validation project
management experience.
·
Created Validation Plans, Requirements, Specifications,
IQ/OQ/PQ Protocols and Test Scripts andFinal Summary ReportsConducted OQ, PQ, UAT testing.
·
Authored
Standard Operating Procedures (SOPs)
and originated application/equipment Change Control Requests.
·
In
depth knowledge of pharmaceutical regulations: cGxP and 21 CFR Part 11, 210, 211 and 820.
·
8 years IT support for Regulatory
Affairs / Proprietary Information systems.
·
Excellent
team player. Works well with management,
vendors and production personnel.
PROFESSIONAL EXPERIENCE
CORELAB
PARTNERS (RadPharm) 2008 - 2011
Senior Validation Engineer
- An
advanced 2D/3D imaging application developed by Siemens for this CRO/Image
Core Lab and used to read and assess clinical trialdata;
- A DICOM
De-Identification System for patient privacy,and
- ADocumentum
Compliance Manager (DCM v6.5) upgrade.
As a lead
validation engineer wrote: Validation Plans, Assessments, Test Plans,
Traceability Matrixes,Final Reportsand developed and executed over
100OQTest Scripts.
MMC CONSULTING (PFIZER,
KING, SCHERING-PLOUGH, BAYER, ROCHE, SANOFI-AVENTIS, WYETH,GE HEALTHCARE)2001
- 2008
Validation Engineer
·
Wrote Validation Plans for new and existing cGxP computer system
applications defining the validation strategy and methodology,
deliverables, IQ/OQ/PQ protocols and acceptance criteria.
·
Authored User and System Requirements and Specifications identifying the functional requirements and
specifications of computer system applications (Documentum, TSM, Oracle, etc)and
GAMP
manufacturing processes (liquid filling and packaging system).
·
Wrote and executedInstallation, Operational and
Performanceprotocols
to verify that the hardware was properly installed, that the software
application functioned properlyand that the system “operated as intended”.
Created Traceability Matrices.
·
Prepared Validation/TestSummary Reports.
Performed follow-up and the resolution of IQ/OQ/PQ Deviation Reports.
·
Validated
/ Revalidateda number of
new and existingDocumentumSystems.
·
Conducted
Audits and Assessments ofcomputer
systems for
21 CFR Part 11, Part 210/211 and Part 820compliance.
·
Wrote, edited and reviewed Standard Operating Procedures (SOPs) to
ensure that they met business needs and compliance requirements.
·
Configured
and validated EMCDocumentumControl Manager (DCM) ver4i/5.1/6.5used as a repository for Standard Operating
Procedures and other controlled documents; and consisting of eContent Server, Document
Transformation and PDF Stamping Services, Full Text Searching and DCM User and
Administrator Clients.
BRISTOL-MYERS SQUIBB 1993-2001
Documentum
System Administrator / Information Architect
·
As a Member of the Documentum
Pilot Team participated in users workshops to define application
requirements, configuration and customizations. Reviewed and evaluated
CoreDossier software for publishing of regulatory submissions.
·
Installed
and supported Documentum on a Sun Solaris Unix Server, InputAccel
Imaging on a Windows NT Server and Documentum 4i clients on PC Workstations.
·
Designed
the cabinet/folder hierarchy and implemented the Repository DocBase. Defined groups and added
users.
·
Wrote and executed Installation, Operational
and Performance Qualification (IQ/OQ/PQ) protocols for Validation testing of
the initial installation and for three upgrades to the system.
·
Administrated and supported the
Documentum system and an associated Imaging application.
·
Identified
opportunities for improved use of the application and revised Functional and
Design Specifications to implement the changes.
·
Trained and coached Documentum users
and resolved vendor/user problems. Trained internet users and designed and authored many intranet web
sites/pages in HTML.
·
Migrated and converted files from a legacy document
repository system to Documentum.
·
Wrote
the Change Control SOP and coordinated and executed Change Control Requests.
·
Administrated and supported Unix Servers,
Optical Jukeboxes, Unix Workstations, Scanners and Image printers for a
Document Repository and Imaging System.
TDM COMMUNICATIONS 1986-1992
Project
Manager
·
Installed,
tested and trained users on a PC
based system for imaging and archiving
laboratory notebooks at a major pharmaceutical company.
·
Marketed
and sold computer systems, PC's, scanners, image printers and other computer
equipment.
·
Designed,
developed and marketed a secure mini cellular telecommunications system for
convention centers and small office buildings.
Planned, scheduled and managed activities and finances for this
project. Supervised a staff of five.
EDUCATION
M.S. Computer ScienceUniversity of Illinois
B.S. Electronic
EngineeringPurdue University
Studied under a Ford Foundation program for
a Ph.D. at University
of Maryland
(NSF Fellowship Award - Honorable Mention)
Download Resume Format
.JPG)
0 comments:
Post a Comment