Subject Matter Expert (SME) , Production Support, Osaka Site (Manager or Specialist)
Core
Lead GMP compliance and audit activities for sterile products while providing technical and management support for global manufacturing operations.
Role type
Senior IC Production Support SME (Sterile Products)
Builds
Sterile injectable drug manufacturing processes and quality systems
Domain
Pharmaceutical manufacturing (sterile injectables) + Regulatory Compliance (GMP)
Required skills
Sterile product manufacturing expertise, GMP compliance (PIC/S, FDA, EU), Regulatory audit management, Troubleshooting, Validation coordination, Lean production, Risk mitigation
Preferred skills
Leadership, Coaching, Agile methodologies, Continuous improvement
Technologies
None explicitly stated
Responsibilities
Lead domestic and international regulatory audits for sterile products, Provide technical and management support for global sterile product supply, Develop and support GMP compliance training plans, Support investigation and troubleshooting to minimize damage, Coordinate validation activities with other departments, Support KPI progress through performance dialogues
Seniority
Senior, hands-on IC with leadership responsibilities
