The Head of Manufacturing will lead end-to-end operations of an Oral Solid Dosage (OSD) pharmaceutical plant in Japan, ensuring compliance with GMP standards, efficient production scheduling and planning, and delivery of high-quality products. This leader will act as the bridge between the production floor and senior management, frequently engaging on the shop floor while also driving strategic planning, cross-functional collaboration, and regulatory readiness.
Key Responsibilities
1. Manufacturing Operations
• Oversee day-to-day OSD manufacturing (granulation, blending, compression, coating, encapsulation, packaging).
• Ensure strict adherence to GMP, GDP, data integrity, and safety standards.
• Approve and monitor MBR/BMR compliance and ensure error-free documentation.
• Drive continuous improvement to enhance yield, reduce cycle time, and improve OEE.
2. Production Scheduling & Planning
• Develop weekly/monthly production schedules in alignment with demand forecasts and SCM priorities.
• Optimize campaign planning and manage efficient product changeovers (Type A/B cleaning).
• Monitor “plan vs. actual” output daily, addressing deviations proactively.
• Manage plant bottlenecks (e.g., coating time, drying capacity) and balance across shifts and equipment.
3. Regulatory & Quality Compliance
• Act as primary manufacturing contact during PMDA and client audits.
• Ensure timely closure of deviations, CAPAs, and risk assessments.
• Support validation (process, cleaning, equipment) and tech transfer of new products.
4. Leadership & People Development
• Lead, mentor, and motivate production managers, supervisors, and operators.
• Promote a culture of accountability, safety, and quality.
• Conduct regular floor walks to ensure presence, engagement, and direct problem-solving.
5. Cross-Functional Collaboration
• Work closely with QA/QC for in-process checks, release testing, and audit readiness.
• Partner with Engineering for equipment availability, preventive maintenance, and capacity expansion.
• Collaborate with R&D/Tech Transfer for smooth introduction of new molecules.
■休日:完全週休二日制, 土, 日, 祝日, GW, 夏季休暇, 年末年始