Job Purpose 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.