Responsible for handling market complaints related to product quality, ensuring timely investigation, documentation, compliance, and implementation of corrective and preventive actions (CAPA) in line with regulatory and company standards.
Role & responsibilities
Complaint Logging & Documentation
- Receive and acknowledge complaints from customer care team or internal teams.
- Record complaints in the Market Complaint with unique identification numbers.
- Maintain accurate and complete documentation of all complaints.
Investigation
- Involve in Failure of products contract manufacturing locations and prepare reports accordingly.
- Coordinate with Production, Quality Control (QC), and other relevant departments/CML to investigate root causes.
- Collect and analyse complaint samples and control samples when required.
- Categorize complaints as Critical, Major, or Minor based on risk to patient safety and product quality.
- Preparation of executive summary of negative feedbacks.
Corrective and Preventive Actions (CAPA)
- Suggest and implement CAPA in consultation with QA Manager and Regulatory Affairs.
- Monitor effectiveness of CAPA and ensure timely closure.
Communication
- Provide timely updates and final responses to complainants.
- Communicate investigation outcomes to Marketing Authorization Holder and regulatory bodies (for export markets).
Compliance & Reporting
- Ensure compliance with GMP, company SOPs, and regulatory requirements.
- Prepare trend analysis reports for periodic review and continuous improvement.
- Support in product recall activities if required.
Additional Requirements:
- Familiarity with electronic complaint management systems.
- Ability to work under strict timelines and regulatory compliance.