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IT Compliance Manager
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- Responsible for creating standard operation procedures, protocols and compliance related documents for IT department in accordance with FDA regulatory and compliance requirements.
- Responsible for the daily operation, troubleshooting, and maintenance of GMP-related information systems to ensure their normal operation and data integrity.
- 5~8 years of pharmaceutical industry experience, specifically around IT audit, compliance, and IT operations.
- Be familiar with FDA regulatory requirements on data integrity and data governance on computerized systems.
- Familiar with FDA regulatory standards, possessing the capability to handle changes, deviations, CAPA (Corrective and Preventive Actions), and similar tasks.
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