QC Qualification Engineer

Job Duties:

• Provide day-to-day quality oversight for QC laboratory and production-related activities in a GMP environment.
• Review, verify, and approve analytical testing data to support timely product and batch release.
• Review and approve QC documentation, including batch records, AS&T documents, and Master Batch Records (MBRs).
• Support batch disposition and release activities in alignment with Quality and regulatory requirements.
• Lead and execute end-to-end qualification of QC laboratory equipment (Group B & C), ensuring compliance with GMP standards.
• Develop, review, and approve qualification documentation, including URS, ERES, HLRA, IOQ, PQ, and Qualification Reports.
• Manage and execute change controls related to QC equipment qualification and lifecycle management.
• Support deviations, investigations, and exception handling, contributing to root cause analysis and corrective actions.
• Provide qualit...