QA Computer System validation for GxP system

Tata Consultancy Services; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Tata Consultancy Services in Hyderabad is seeking a Regulatory Compliance Governance and Strategy consultant to support governance and strategy for regulated solutions.

You will collaborate with IT stakeholders for regulatory risk assessment, provide quality support for projects and changes, aid audit readiness, guide documents and records management, and drive improvements to close compliance gaps.

Qualifications

• Experience in providing Regulatory Compliance Governance and Strategy consulting.
• In-depth knowledge of FDA regulations 21 CFR Part 11, 21 CFR Part 820, GxP, GAMP 5, SOX, ISO 9001, ITIL.

Responsibilities

• 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.

Skills

Regulatory compliance

Regulatory risk assessment

Audit readiness

Documents management

SOP adherence

Job description

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