QA Engineer

ACG

3 - 5 years

7 - 9 Lacs

Mumbai Mumbai Suburban Mumbai (All Areas)

Posted:9 hours ago| Platform:

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Skills Required

Track And Trace validation 21 Cfr Part 11 Capa MySQL JIRA

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

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

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