American CyberSystems
Duluth, GA
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Job Description :
The role engages with IT and business for the Argus (Drug Safety Systems) activities.

Participates in user requirement gathering, and transforms user requirements to functional requirements leading into system design.
Develops business process workflow diagrams and system level logical/physical architecture diagrams.
Conducts, provides and is accountable for the accuracy of project work estimates.
Works with IT Validation lead and IT technical lead to analyze and resolve technical deviations identified during validation qualification.
Formulates options including assessing their relative merits and risks, and works with respective stakeholders to determine the best solution.
Can readily re-apply technical and business insights to new situations.
Performs execution and review of installation procedures and installation qualification documents.
Performs review of design specification and operational procedure documents.
Performs review of system configuration against the documented Argus system specifications.
Understands and performs validation activities in accordance with compliance requirements (GxP or CFR 21 Part 11 Aware of when regulatory issues are applicable and whom to engage to address any concerns