QA Production Oversight

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, pro

דרישות:

• 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