Engineer,Quality, ACG Inspection

ACG; Mumbai; Presencial; INR 900.000 - 1.200.000; Jornada completa

Descripción de la vacante

ACG in Mumbai seeks a validation specialist to assist in validating Track and Trace and Inspection systems, drafting and executing IQ, OQ, IOQ and PQ protocols and supporting system verification to meet regulatory standards.

You will collaborate with Development, Engineering, IT, PMO, Production and Service teams during implementation and testing, and you will review and maintain validation docs, test scripts, deviation reports and traceability matrices.

Responsabilidades

• Assist in 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

Descripción del empleo

1. Assist in the validation of Track and Trace and Inspection systems, including drafting and executing IQ, OQ, IOQ and PQ protocols.
2. Support system verification activities to ensure compliance with 21 CFR Part 11 and other regulatory standards.
3. Collaborate with cross-functional teams (Development, Engineering, IT, PMO, Production, Service) during implementation and testing phases.
4. Review and maintain validation documentation, including test scripts, deviation reports, and traceability matrices.
5. Monitor and report system performance, helping to identify non-conformities and supporting CAPA activities.
6. Participate in audits and inspections, providing validation records and technical support as needed.
7. Ensure proper change control procedures, User manuals, Screen changes, OQ and IOQ are followed for any system modifications or upgrades.
8. Provide training and guidance to end-users on system functionality and compliance requirements.
9. Conducting Demo, Meetings and Factory acceptance test for product and softwares
10. Providing Remote support and sometime on site support for beta validation or for critical issue analysis.
11. Automation of product, software validation and testcases
12. Jira management and Test cases creation
13. Maintaing release documents and release history
14. MySQL and MsSQL database management

Basic Electronics and IT Troubleshooting