[IEEE-bhpjobs] Fwd: PERM AND CONTRACT: RTP, NC: CSV-ERP-CHANGE CONTROL

[EstherLumsdon]

---------- Forwarded message ----------
From: Scott <scottmckear... at gmail.com>
Date: Apr 3, 6:03 am
Subject: PERM AND CONTRACT: RTP, NC: CSV-ERP-CHANGE CONTROL
To: Computer Validation Jobs Report


JOB 273044

Computer Systems Validation
 RTP NC

Experience Required:
2-3 years minimum experience in a Software Validation
Experience with FDA and SOX
4-6 years experience in Information Technology
Medical device industry experience is preferred.
Experienced with ERP systems.

Major Job Responsibilities:
Tracking and releasing Change Control managed application (including
ERP) changes;
Maintaining detailed records in support of system changes;
Training users and fellow IT team members on the principals of
computer system compliance;
Communicating to and ensuring the user community understands and is
ready to accept changes;
Optimizing processes for efficiency;
Contribute to the development, collection and reporting of metrics
Meeting with internal auditors working from a SOX, FDA, corporate
policy or similar group in support of compliance;
Take part in software validation projects by preparing validation
protocols, reviewing requirements and design specifications,
Installation and Operational Qualifications and Summary Reports;
A basic understanding of Project Management;
Maintaining documentation, either electronically or physically,
according to policy/procedure;
Experience with demand / capacity planning and prioritization;
Advise and support the IT infrastructure with respect to regulatory
compliance.
Provide computerized system validation consultation and evaluation;
Train the IT department in change control procedures involving
computer system, infrastructure and application validation and
qualification;
Ensure the traceability matrix is maintained;
Perform other duties as assigned by management.

Education Required:
BA/BS in Computer Science or Engineering preferred or equivalent
industry experience
2-3 years minimum experience in a Software Validation
4-6 years experience in Information Technology
Medical device industry experience is preferred.

REPLY TO THIS POST:  SEND RESUME TO: SC... at KEYREQUIREMENTS.COM
scott at keyrequirements.com

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