• Assist in the validation of Track and Trace and Inspection systems, including drafting and executing IQ, OQ, IOQ and PQ protocols.

• Support system verification activities to ensure compliance with 21 CFR Part 11 and other regulatory standards.

• Collaborate with cross-functional teams (Development, Engineering, IT, PMO, Production, Service) during implementation and testing phases.

• Review and maintain validation documentation, including test scripts, deviation reports, and traceability matrices.

• Monitor and report system performance, helping to identify non-conformities and supporting CAPA activities.

• Participate in audits and inspections, providing validation records and technical support as needed.

• Ensure proper change control procedures, User manuals, Screen changes,



OQ and IOQ are followed for any system modifications or upgrades.

• Provide training and guidance to end-users on system functionality and compliance requirements.

• Conducting Demo, Meetings and Factory acceptance test for product and softwares

• Providing Remote support and sometime on site support for beta validation or for critical issue analysis.

• Automation of product, software validation and testcases

• Jira management and Test cases creation

• Maintaing release documents and release history

• MySQL and MsSQL database management

Basic Electronics and IT Troubleshooting

📌 Engineer,Quality, ACG Inspection (India)
🏢 ACG
📍 India