QA Computer System validation for GxP system

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