M&S-Head of Inspection PCU _Fill & Finish-Beijing
Core
Lead the Inspection Process-Centric Unit (PCU) for Fill & Finish operations, ensuring 24/7 production performance, compliance with China GMP and Sanofi standards, and continuous improvement in safety, quality, and yield.
Role type
Senior IC manufacturing operations lead (sterile fill & finish)
Builds
Sterile pharmaceutical products via fill and finish lines
Domain
Pharmaceutical manufacturing (sterile/aseptic)
Required skills
Sterile manufacturing expertise, Quality system management, GMP compliance, Lean manufacturing, Deviation/Change management, Team leadership, Process optimization, Equipment qualification, SOP development, Training delivery
Preferred skills
SMS2.0 implementation, Product transfer project experience, OEE/yield improvement, 5S/HSE practices
Technologies
SMS2.0, GMP, Lean, 5S, HSE
Responsibilities
Supervise 24h shift operations and define daily/weekly/monthly priorities; Ensure adherence to SMS2.0 standards and asset care activities; Lead Level 1 and Level 2 meetings (QDCI, CI, Asset care, Deviation management); Review performance and upskill PCU members; Optimize production processes and equipment for commercial operation readiness; Manage production environment, hygiene, and facilities for GMP compliance; Execute equipment qualification and process validation; Train production operators on initial and continuous requirements; Coordinate shifts and cross-functional communication (QA, Planning, Maintenance); Implement CAPA for deviations and complaints; Develop and improve SOPs; Report product complaints and adverse drug reactions.
Seniority
Senior, hands-on IC
