Experience in providing Regulatory Compliance Governance and Strategy consulting
In-depth knowledge of FDA regulations 21 CFR Part 11 (Electronic Records and Electronic Signatures, Audit Trails and Security events), 21 CFR Part 820, GxP Regulations, GAMP 5, SOX Regulations, ISO 9001, ITIL processes
Collaborating with IT stakeholders for conducting Regulatory Risk Assessment of quality systems, solutions and services
Provide Quality support for the Projects and Application and Infrastructure changes
Support of Audit and Inspection Readiness of regulated solutions
Guiding IT stakeholder on Documents and Records Management
Providing recommendations to close the existing compliance gaps and improve the processes
Ensuring compliance to SOPs, policies and procedures
Conducting and coordinating periodic review of GxP applications
📌 QA Computer System validation for GxP system (Secunderabad)
🏢 Tata Consultancy Services
📍 Secunderabad
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