Subject Matter Expert (SME) , Production Support, Osaka Site (Manager or Specialist)
Core
Lead GMP compliance activities, provide technical consulting for sterile product manufacturing processes, and support agile troubleshooting and continuous improvement at a pharmaceutical production site.
Role type
Senior IC Production Support SME (Sterile Products)
Builds
High-quality sterile injectable pharmaceuticals
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
GMP compliance (PIC/S, FDA, EU), sterile product manufacturing processes, regulatory knowledge, troubleshooting, validation, leadership, coaching
Preferred skills
Bachelor's or Master's in Pharmacy, Chemistry, or Engineering
Technologies
None stated
Responsibilities
Lead domestic and foreign regulatory inspections and audits for sterile products; Provide technical and management support for global supply and new sterile product manufacturing facilities; Support GMP compliance training plans to prevent violations; Support investigation and troubleshooting to minimize damage; Collaborate on validation activities; Support KPI progress through performance dialogues and agile activities.
