CSV Automation

Key Responsibilities:

• Develop, execute, and document Computerized System Validation (CSV) protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), along with the preparation of final validation reports.
• Support the Periodic Review program under the Site Validation Maintenance Program , ensuring that systems remain in a validated state throughout their lifecycle.
• Participate in and support change control activities , performing validation impact assessments and ensuring proper documentation in compliance with regulatory standards.
• Assist in day-to-day validation tasks, ensuring all activities are conducted in accordance with approved Standard Operating Procedures (SOPs) , Validation Plans , and Validation Policies .