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 man
Requirements: B.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
This position is open to all candidates.
