Role Summary

The IT Quality Assurance role is responsible for ensuring that GxP-critical applications meet regulatory compliance through robust validation practices, audit preparedness, and quality governance. This role will lead Computer System Validation (CSV) efforts, manage audit documentation, and oversee quality processes including SOPs, deviations, CAPA, and change control across Quality, Regulatory, and R&D systems. This role is the authoritative compliance oversight function within IT for GxP computerized systems. The role acts as the quality gatekeeper to ensure systems are validated, controlled, audit-ready, and compliant throughout their lifecycle. IT-QA provides independent review and approval of compliance deliverables and drives closure of gaps through a solution-oriented, collaborative approach.

Job Responsibility

Computer System Validation (CSV)

• Lead validation activities for GxP applications including IQ/OQ/PQ protocols.
• Develop and maintain validation documentation such as validation plans, test scripts, traceability matrices, and summary reports.
• Ensure validation practices align with applicable regulatory standards (e.g., FDA 21 CFR Part 11, EU GMP).

Audit Readiness & Compliance

• Review and Manage audit-ready documentation for validated systems including policies, SOPs, change controls, checklists, quality plans and risk assessments.
• Support internal and external audits by preparing validation packages and participating in system walkthroughs.
• Collaborate with QA and business teams to address audit observations and implement corrective actions.

IT Quality Governance & Documentation

• Define and maintain process governance frameworks for GxP systems in collaboration with cross-functional teams.
• Author and maintain Standard Operating Procedures (SOPs) related to CSV, audit compliance, and IT quality processes.
• Ensure documentation is current, complete, and compliant with regulatory expectations.

Risk Management & Issue Resolution

• Conduct IT assessments for deviations, root cause analysis (RCA), and corrective and preventive actions (CAPA).
• Maintain a centralized tracker for deviations and CAPA to ensure timely resolution and closure.
• Perform risk assessments for new and existing systems and changes impacting GxP compliance.

Change Management

• Manage IT-related change control processes for GxP systems.
• Ensure all changes are properly documented, assessed for impact, and approved before implementation.
• Coordinate with business and QA teams to ensure change control compliance and traceability.

Periodic Review Program & Continuous Compliance

• Own periodic review program for validated systems: validation state review, trends, access review, open deviations, change trends, vendor performance, and data integrity checks.
• Publish compliance health indicators and drive continuous improvement actions

Training & Support

• Conduct training sessions for IT and business users on CSV procedures, audit protocols, and quality processes.
• Provide guidance on compliance with best practices and regulatory expectations.
• Define compliance training needs (role-based) and ensure completion evidence is maintained.
• Deliver targeted training/workshops on CSV practices, audit readiness, documentation quality, change control discipline, and data integrity expectations.
• Coach teams to build capability—firm on requirements, supportive on execution.

Additional Responsibilities

• Perform other quality-related IT tasks as assigned by the Head of Department (HOD), following instructions and guidance.