What are the responsibilities and job description for the IT GXP Compliance Consultant position at Dynamic Enterprise Solutions Inc?
Job Details
Description:
Primary responsibility of the role is to support the Exception Reporting (ER) process. Serving as Event Owner, drive the execution of Root Cause Analysis (RCA), Correction and Corrective Action/Preventive Action (CAPA) planning and execution in response to IT system issues identified to have violated a Quality requirement. The secondary responsibility of the role is to manage and drive application retirement/decommissioning efforts. Partner with system owners, records management, information governance, and legal resources to ensure the timely and compliant execution of the end-to-end decommissioning process. For both ER and Decommissioning, provide weekly updates on progress, including the identification of roadblocks and the need for escalation.
3-5 years of experience operating in a GxP environment
1-3 years of experience with Exception Reporting (ER), and Corrective Action/Preventive Action (CAPA) processes
1-3 years of experience with Software Lifecycle (SLC)
Application decommissioning/retirement experience a plus
Audit support experience a plus
Ability to conduct cross-functional discussions with IT (technical) and business (process) Subject Matter Experts (SMEs) in response to system events and failures. Applies critical thinking and can use standard tools and techniques to assess and determine root cause. Understands the need for clear, complete, and accurate documentation (following good documentation practices). Ability to work independently once provided direction/instructions. Comfortable asking questions when things are unclear, and the ability to escalate when needed to ensure tasks remain on track.
