Posted:12 hours ago|
Platform:
Work from Office
Full Time
Receive and Log Complaints : Record and evaluate complaint submissions from customers regarding manufacturing defects or issues. Ensure all complaints are logged accurately in the complaint management system. Investigate Complaints : Conduct thorough investigations to determine the root cause of the complaint. Coordinate with internal departments (Quality Assurance, Regulatory Affairs, Production) to gather necessary information. Communicate with Stakeholders : Communicate with customers to understand their concerns and provide updates on the investigation. Liaise with healthcare providers, if applicable, to acquire relevant complaint information. Regulatory Compliance : Ensure timely processing of complaints in accordance with regulatory requirements. Generate and submit reports to appropriate authorities and government agencies as required. Corrective Actions : Recommend and implement corrective and preventive actions (CAPA) to address and prevent recurrence of issues. Monitor the effectiveness of implemented actions. Documentation and Reporting : Maintain detailed records of all complaint investigations and resolutions. Prepare trend reports and metrics to capture and analyze complaint data. Audit Preparation : Participate in activities to prepare for audits and inspections. Ensure all documentation is compliant with GMP (Good Manufacturing Practices) standards.
Zydus Lifesciences
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