QA Computer System validation for GxP system

Job description

Job Description - -------------- Exp: 5 - 10 Years Job Location: Hyderabad 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