QA Production Oversight
Position Overview We are looking for a hands-on QA Production Oversight professional to provide real-time GMP oversight on the production floor in a sterile manufacturing environment, ensuring compliant execution of sterile production activities and timely escalation of quality risks. About the Role We are looking for a hands-on QA Production Oversight professional to provide real-time GMP oversight on the production floor in a sterile manufacturing environment. This is a shift-based role focused on ensuring compliant execution of sterile production activities and timely escalation of quality risks. Key Responsibilities 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 documentation 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, document, 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. Requirements Sc. in Life Sciences, Biotechnology, Biology, Microbiology, Chemistry, Pharmacy, Chemical Engineering, or a related scientific discipline – Must. Additional GMP, aseptic processing, contamination control, or quality systems training – Must. 5+ years of QA, production, or quality oversight experience in sterile pharmaceutical manufacturing. Practical GMP experience in cleanrooms, aseptic processing, batch documentation, line clearance, deviations, CAPA, and production-floor investigations. Good understanding of contamination control, EM, gowning practices, cleanroom behavior, aseptic interventions, and data integrity principles. Ability to work independently on the production floor, make risk-based decisions, and escalate issues appropriately.
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