Lead QA Oversight Production
Core
Lead QA Oversight for sterile injectable drug production, ensuring GMP-compliant manufacturing and quality monitoring on the shop floor.
Role type
Senior QA Lead (Shopfloor Oversight)
Builds
Sterile injectable pharmaceuticals (oncology therapeutics, pre-filled syringes, vials)
Domain
Pharmaceutical manufacturing (GMP, sterile/aseptic production)
Required skills
GMP compliance, aseptic manufacturing, quality assurance, team leadership, deviation/CAPA management, audit readiness, documentation review, risk assessment
Preferred skills
cGMP regulations, data integrity, parenteral products, shift work
Technologies
GMP systems, production equipment, cleanroom environments
Responsibilities
Lead and coordinate QA Shopfloor Oversight team; oversee QA monitoring in production areas; monitor weighing, aseptic filling, visual inspection, line clearance, cleaning, and product segregation; ensure GMP-compliant processes and documentation; train and develop technicians; evaluate quality issues and make QA decisions; coordinate deviations, CAPAs, and change controls; ensure audit readiness and report quality metrics.
Seniority
Senior, hands-on IC