Complaint Handling Quality Staff – Fuji Plant

About the role

The Complaint Handling Quality Staff is responsible for managing complaint investigations at the Fuji Plant. This site‑based role ensures that all complaint records are investigated, documented and closed in compliance with regulatory requirements and company procedures.

Key responsibilities

• Execute site‑based complaint investigations, including field sample confirmation and evidence assessment.
• Document investigation activities, root‑cause analysis, risk evaluation and closure information in the complaint record.
• Coordinate inputs from manufacturing, QC, engineering, supply chain, affiliates and external partners.
• Support process monitoring, trending, continuous improvement and inspection readiness.

Required profile

• Bachelor’s degree in Life Science or related discipline (or equivalent experience).
• 2–4 years of experience in quality investigations, complaints, deviations or non‑conformances.
• Proven ability to prepare clear, concise investigation documentation and manage multiple records.

Required skills

• Knowledge of cGMP and Good Documentation Practices.
• Experience with complaint handling, root‑cause analysis and risk assessment.
• Familiarity with regulatory expectations for quality investigations.