1. Digerati Search, Inc. ESSENTIAL FUNCTIONS
" Manage project team including technical lead, validation coordinator, business analyst, and support analyst
" Manage requirements, design, development, validation of system extensions, enhancements, and fixes
" Work with user base and senior management to identify, prioritize and coordinate extensions, enhancements, and fixes
" Work with user base and senior management to define scope of system changes
" Coordinate implementation of system change controls
" Participate in regulatory agency reviews and system audits
" Work with training department to introduce new functionality to user community
" Thorough understanding of 21 CFR 11, GMP compliance, and validation in a regulated environment
" Possess working knowledge of system validation processes including IQ (Installation Qualification), OQ (Operational Qualification, and PQ (Performance Qualification).
" Coordinate project documentation.
" Own project deliverables including Project Implementation Plan, Project Plan, and Project Summary Report.
" Provide guidance to deliverables including Configuration Specification, Custom Design Specification, Installation Qualification Protocols, Acceptance Test Plan, Acceptance Summary Report, and Validation Test Cases.
" Lead and facilitate Requirements Gathering workshops with business process owners.
" Oversee development, staging, training, validation, and production environments
EDUCATION/EXPERIENCE " BS degree in a technical discipline with at least 3-5 years project management experience in pharmaceutical industry
" PMI Certification a plus
TECHNICAL SKILLS " Hands-on experience with Argus Safety? System.
" Participate in design of system architecture and infrastructure
" Participate in design of failover, backup, and disaster recovery solutions
" Tools/Technologies utilized: Microsoft Project, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Microsoft Visio, Windows NT, Windows 2000, Windows 2003, HPUX 11i, Tivoli, Altiris
COMMUNICATION SKILLS " Exhibit strong communication, management, and leadership skills
" Demonstrate ability to interact with all levels of corporate organization
" Collaborate and work effectively with individuals and teams inside and outside of IT organization
" Identify and articulate potential risks associated with various project elements. Keep IT management informed on ongoing basis of potential risks.
" Provide recommendations on courses of action leading to successful and timely execution of projects.
PLANNING SKILLS " Work with business and IT management to anticipate business needs and issues with respect to content management
" Recognize and take appropriate actions to resolve issues within Argus Safety? System.
" Take action to minimize risk and exposure with regards to regulatory agencies.
PROBLEM SOLVING " Use innovative approaches in defining solutions within the electronic document management system
" Work with project team members, Argus Safety? users and support consultants to develop solutions within the software and hardware, test the Argus system, debug errors, and diagnose system problems in the development, staging, training, validation, and production environments.
ACCOUNTABILITY " Implement & fully comply with all IT governance and system validation procedures
" Take personal responsibility for meeting deadlines and ensuring success of projects From:http://www.digeratisearch.com Added on: 2007-09-20 19:31:28 Language:English Misc > Jobs
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