Malcolm Stewart
IT Compliance Analyst at Novo Nordisk
- Role
- IT Compliance Analyst at Novo Nordisk
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Malcolm Stewart
Accomplished Automation and IT Compliance Professional with over 14 years of experience supporting, validating, and optimizing manufacturing computer systems in FDA-regulated GxP environments. Proven expertise in automation systems administration, IT compliance, data integrity, and computer systems validation (CSV). Skilled in bridging automation, IT, and quality functions to drive compliant, efficient, and reliable manufacturing operations.
Experience
IT Compliance Analyst
Aug 2024 — Present · Durham, NC, US
Improve our capability to provide quality to all IT & automation processes by analyzing & improving the levels of compliance (Project management, Quality programs)• Ensure IT data systems are available, capable & accessible so that IT systems operate at the speed of business processes through quality initiatives & projects (ARE Management, business continuity & IT support)• Recommend & implement quality initiatives to meet the customer’s needs, regulatory & internal compliance & add value to all business processes• Become subject-matter expert (SME) with NN validation software, eTIMs, within the IT team• Project management – develop & utilize skills necessary to develop, manage & implement IT projects of all sizes (small to large scale projects)• Follow all safety & environmental requirements in the performance of duties• Manage change requests & system validation for IT• Serve as IT lead for audits• Site Data Integrity Steward• Coordinate with QA Compliance Specialists to assure compliance with procedures & policies• Support & practice IT Security• Follow all safety & environmental requirements in the performance of duties• Comply with internal & external regulations & procedures• Follow all safety and environmental requirements in the performance of duties• Other duties as assigned
Education
North Carolina Agricultural and Technical State University
B.S, Electrical Engineering
Skills
- Rsview 32
- Panelmate Configuration
- Factorytalk View
- Control Systems Design
- Manufacturing
- Minitab
- Panelview Plus
- Ethernet/Ip
- Troubleshooting
- Process Control
- Controllogix
- Root Cause Analysis
- Ifix
- Automation
- Gmp
- Scada
- Control Logic
- Dmaic
- Sql Commands
- Installation Qualification
- Change Control
- Cognex Dataman
- Fmea
- Gdp
- Plc-5
- Allen Bradley
- Nachi Robots
- Operational Qualification
- Validation
- Spc
- Cognex in-Sight Explorer
- Slc500
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