Product Complaint Specialist

• Receive and log product complaints from customers, sales team, or regulatory bodies in the complaint management system.
• Acknowledge receipt of complaints and communicate resolution timelines to complainants.
• Evaluate the complaint to determine if it qualifies as a reportable event per regulatory requirements.
• Coordinate with cross-functional teams (R&D, Quality, Manufacturing, etc.) to investigate root cause(s).
• Ensure timely and accurate completion of complaint investigations, CAPA initiation (if required), and closure within defined timelines.
• Document complaint details, investigation findings, corrective actions, and outcomes.
• Communicate findings and resolutions to stakeholders and customers.
• Generate monthly/quarterly complaint trend reports and risk assessments.
• Support external/internal audits and regulatory inspections by providing complaint-related documentation.
• Maintain compliance with company SOPs, ISO standards, and regulatory requirements.
• Recommend preventive actions and contribute to quality improvement initiatives.
• Bachelor’s degree in Pharmacy, Science, Biomedical Engineering, or equivalent field.