Engineer
Date: Sep 23, 2025
Location: kandivali, India
Company: ACG
- 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