Validation Project Manager Consultant

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Somerset, NJ

 This is a long term contract and the rate is open.

I. Department Overview:

In this position, the PM is responsible for managing and performing computer validation activities on the JD Edwards validation documentation upgrade project.

II. Basic Function:

Develop and lead validation efforts for the JD Edwards validation documentation upgrade project.

III. Specific Activities and Responsibilities:

Project will be performed in two phases.

Phase I responsibilities:

·         Review current operations of the JD Edwards system

·         Perform High Level Risk Assessment of the system

·         Identify the correlation between core and site specific functionality

·         Identify necessary project’s involvement of business owners and IT SMEs

·         Estimate the timelines and cost for Phase II

·         Create detailed project plan for the Phase II

·         Create Validation Plan for the project including assessing what CSV deliverables need to be included in the project and creating CSV documents.

 

Phase II responsibilities:

·         Create validation deliverables as per the Validation Plan approved in Phase I

·         Use risk based computerized systems validation strategy based on GAMP 5

·         Perform Functional Risk Assessment

·         Review/update documentation for interface (DSI, Optio, etc.)

·         Define core system requirements and site specific requirements

·         Locate applicable IQs for the hardware and software

·         Create and perform OQs for defined high risk functionality of core system, plus OQs for site specific requirements (possibly grouped by business operations)

·         Perform PQ for the core business flow and separate PQs for sites

·         Create/Update JDE system SOPs

·         Implement controls for JD Edwards documentation for post-implementation phase

·         Train site CSV coordinators

 

IV. Knowledge Requirements:

 Bachelor of Science in an Engineering, Computer Science or other relevant Science Field

 

Knowledge/Skills Requirements:

Ability to communicate with all levels of corporate and site management

Experience with Microsoft Project

Experience with JD Edwards system - ability to operate a system and understands what it does with minimal help from IT resources. Know what aspects of the system need to be validated: interfaces, security, etc.

Experience with performing majority of the tasks listed in the Responsibilities section

Project Management experience and/or PMP certification

Extensive pharmaceutical experience a MUST

 


Posted by HCR Group, Inc. over 2 years ago

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