Sneh Gandhi

A Senior Executive of CSV (Computer System Validation) & IT Compliance Lead typically holds a leadership role responsible for overseeing and ensuring compliance with regulations governing IT systems and software within an organization.

key responsibilities:

• CSV Management
• IT Compliance Oversight
• Handling of all QMS tools (Change Control, CAPA, Incident/ Deviations)
• Collaboration with Stakeholders
• Audits and Inspections

A Senior Executive - ITQA (IT Quality Assurance) is responsible for ensuring the quality and compliance of IT systems and processes within an organization.

Key Responsibilities:

• IT Quality Assurance Management (Implementation of IT SOPs and Protocols)
• Test Planning and Execution in CSV of GxP software
• Compliance and Regulatory Requirements
• Collaboration with Cross-functional Teams
• Handling of Incident and Issue Management
• Handling Training and QMS activity related to IT

A Corporate IT Quality Assurance (ITQA) role focuses on ensuring that IT systems, processes, and technologies used across an organization adhere to established quality standards and regulatory requirements. This position is typically responsible for overseeing the quality of IT projects at a corporate level, ensuring systems meet organizational objectives, regulatory guidelines, and customer expectations.

Key Responsibilities:

• Implementation of Corporate IT Quality Assurance Strategy
• Monitoring of IT System Compliance and Standards
• CSV activity of Centralized Software (Test Management)
• Collaboration with IT and Business Teams
• Risk Management and Issue Resolution
• Reporting and Metrics
• Training and Development

The CSV Project Leader oversees the planning, execution, and delivery of computer system validation projects, working closely with cross-functional teams, ensuring that systems are validated appropriately, and ensuring ongoing compliance.

Key Responsibilities:

• Project Leadership and Management
• Validation Documentation and Reporting
• Collaboration with Cross-Functional Teams
• Compliance Oversight
• Training and Mentorship
• Audit and Inspection Support

Key Responsibilities:

• Software Testing and Validation
• Validation Documentation
• Collaboration with Cross-Functional Teams
• Compliance with Regulatory Standards