Engineer,Quality, ACG Inspection

ACG World; Mumbai Suburban; On-site; INR 800,000 - 1,400,000; Full time

Job summary

ACG World is seeking an experienced Validation Specialist in Mumbai Suburban to assist in validating Track and Trace and Inspection systems. You will draft and execute IQ/OQ/IOQ/PQ protocols, support verification activities for regulatory compliance, and collaborate with cross-functional teams during implementation and testing.

The role involves maintaining validation documentation, monitoring system performance, and supporting CAPA activities to ensure quality and regulatory adherence.

Qualifications

• Experience validating Track and Trace and Inspection systems with IQ/OQ/IOQ/PQ protocols.
• Knowledge of 21 CFR Part 11 and related regulatory standards.
• Collaborate with Development, Engineering, IT, PMO, Production, Service during implementation and testing.
• Maintain validation documentation including test scripts, deviation reports, and traceability matrices.
• Monitor system performance and support CAPA activities.

Responsibilities

• Assist in validation of Track and Trace systems including drafting protocols.
• Support verification activities for regulatory compliance.
• Collaborate with cross-functional teams during implementation and testing.
• Review and maintain validation documentation.
• Monitor performance and report non-conformities.

Skills

IQ/OQ/IOQ/PQ protocols

Regulatory compliance

Jira management

SQL databases

Cross-functional collaboration

Documentation maintenance

Tools

Jira

MySQL

MS SQL Server

Job description

Select how often (in days) to receive an alert:

• 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