Manage the end-to-end market complaint handling process in compliance with regulatory requirements and company procedures.
Review, assess, and classify market complaints based on criticality, severity, and potential product quality impact.
Lead investigations related to product quality complaints and coordinate with Cross-Functional Teams (QA, QC, Production, Warehouse, Supply Chain, Regulatory Affairs, and Pharmacovigilance).
Perform root cause analysis using quality tools and ensure implementation of effective Corrective and Preventive Actions (CAPA).
Review batch manufacturing records, analytical reports, stability data, deviation reports, and other quality documents during investigations.
Evaluate complaint trends and identify recurring issues requiring corrective action.
Prepare investigation reports and ensure timely closure of complaints within defined timelines.
Assess the need for product recalls, field alerts, risk assessments, and regulatory notifications based on investigation outcomes.
Maintain complaint databases, metrics, and trend analysis reports for management review.
Support regulatory inspections, customer audits, and internal quality audits related to market complaint management.
Collaborate with Regulatory Affairs and Pharmacovigilance teams for complaint reporting and compliance activities.
Develop and update SOPs related to complaint handling, investigations, and CAPA management.
Train and mentor QA team members on complaint investigation procedures and quality systems.
Ensure compliance with cGMP, GDP, data integrity requirements, and global regulatory expectations.
