Provide on-the-floor QA oversight during sterile manufacturing activities, including aseptic processing, filling, filtration, cleaning, set-up, line clearance, and routine production
Ensure real-time compliance with approved batch records, SOPs, GMP requirements, aseptic practices, gowning, material/personnel flow, and contamination control expectations
Review and verify GMP ation during the shift, including batch records, logbooks, forms, line clearance records, equipment status, and critical process entries for accuracy, completeness, and data integrity
Identify, assess, , and escalate quality events, deviations, documentation errors, process anomalies, EM concerns, and potential contamination risks in real time
Support deviation initiation, impact assessment, containment actions, investigation inputs, CAPA follow-up, and batch-related quality decisions with Production and QA management
Observe and challenge aseptic interventions, cleanroom behavior, line practices, material handling, equipment use, and adherence to contamination control requirements
Participate in shift handovers, production meetings, and escalation discussions to maintain continuity of quality oversight across shifts
Support media fills, qualification/validation batches, engineering or maintenance interventions, and production readiness activities from a QA perspective
Promote shop-floor quality culture and audit readiness through GMP coaching, documentation discipline, aseptic conduct, and right-first-time execution