[Japan] 滋賀品質管理チーム スペシャリスト

Conduct quality control test record judgments and approvals, manage standard samples and reagents, and approve root cause investigations for out-of-specification results. Execute stability monitoring plans, maintain LIMS systems, and oversee calibration and maintenance approvals for testing equipment. Respond to internal and external audits, develop training schedules, and monitor quality KPIs to drive continuous improvement. Participate in cross-departmental projects aligned with production and quality strategic goals. Provide leadership and mentorship to team members while autonomously resolving complex regulatory challenges in compliance with GMP and ICH guidelines.