CSV Expert

4 days ago


India Skywaves Rise Full time

Job Description CSV (Computer System Validation) Expert Remote Full time HIPAA / PHI Mandatory 6+ years of experience is mandatory The opportunity: Develop and Implement CSV Strategies: define qualifications approaches, including quality plans, test protocols, and risk assessments in compliance with GxP requirements. Support GxP & HIPAA Compliance: ensure product development and lifecycle activities adhere to regulatory standards such as FDA, EMA, HIPAA, and other relevant guidelines. Ensure Data Security & Integrity: oversee compliance with HIPAA regulations related to electronic Protected Health Information (ePHI), access controls, encryption, and audit logging within validated systems.


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