What are the responsibilities and job description for the GXP Systems Analyst position at Puresoft, Inc.?
Job Details
GXP Systems Analyst
Waukegan IL - Hybrid
6 Month
Exp:: 7 Years candidate
Shortlisting likely 2/7 at 3:30 PM Central Time.
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.
Required:
- 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
Responsibilities:
- 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.
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