Senior GxP Systems Analyst
1 week ago
We are seeking a highly skilled GxP Systems Analyst to join our team at Insight Global. As a key member of our IT department, you will be responsible for supporting the management of GxP applications throughout the system lifecycle.
Key Responsibilities- Support the system administration of GxP applications in our client's environment, including Master Control, Trackwise Digital, Tracelink, Part 11 DocuSign, Veeva, and Argus.
- Analyze, design, develop, and install GxP applications in accordance with established SOPs.
- Provide GxP Computer System administration, escalation point, and maintenance support.
- Prepare, review, and approve GxP Computerized Systems Validation lifecycle documents as an IT GxP SME.
- Support analysis, resolution of Incident Management and technical investigations.
- Follow company's change management process to comply with ITGC policies.
- At least 8 years of hands-on technical IT experience.
- Minimum additional 5 years of experience supporting GxP (GMP, GLP, GCP) computerized systems in the biopharmaceutical/pharmaceutical industries.
- Associate's degree in a related field or relevant experience.
- Full understanding of CFR Part-11 rules and their application to regulated and validated (GxP) systems.
- Full understanding of Computer System validation methodology.
- Experience in requirements definition and analysis and flow charting.
- Familiarity with System Development Lifecycle and GAMP5 methodology.
- Excellent communication and interpersonal skills.
We offer a competitive benefit package, including medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.
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Senior GxP Systems Analyst
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