M PURNA CHANDRA RAO

Company Overview: Medtronic is a global leader in medical technology, specializing in developing and manufacturing medical devices across various healthcare areas.

• Oversee the post-market complaint handling process for a portfolio of Class II and Class III medical devices, ensuring compliance with FDA regulations (21 CFR Part 820) and ISO 13485 standards.
• Handling of complaints from end to end process, i.e. From intake to closure, by ensuring timely completion in compliance with internal procedures and regulatory timelines.
• Ensure regulatory reporting of serious adverse events (SAEs), product defects, in compliance with FDA, EU MDR, and other regional regulations.
• Managed the investigation of product complaints for various medical devices, ensuring full compliance with regulatory requirements.
• Conduct detailed root cause analysis, and implement CAPA to address and mitigate recurring issues, improving product quality and customer satisfaction.
• Review and analyze complaint data to identify trends, quality issues, and areas for continuous improvement, providing feedback to relevant departments for design improvements and process optimizations.
• Organizing and executing internal audits of the complaint handling process to ensure compliance with ISO 13485 and FDA requirements.
• Manage and update Complaint Handling Software (SmartSolve/SAP) to maintain accurate records, and ensure proper tracking and documentation.

Company Overview: Aurore Life Sciences Ltd is a fast-growing pharmaceutical company specializing in the development, manufacturing, and supply of high-quality Active Pharmaceutical Ingredients (APIs) for global markets.

• Leading a group of 15 members as a QA Manager and responsible for ensuring compliance in the Active Pharmaceutical Ingredients (API) manufacturing site.
• To oversee the quality management system and audit management of two manufacturing sites of Aurore Life Sciences.
• Responsible for providing audit response reports to regulatory and customer audit observations.
• Qualification and monitoring of external manufacturing units to ensure the units are providing good quality KSMs/intermediates.
• Conducting internal audits to ensure procedural compliance and GMP practices are in acceptable condition.
• To prepare and execute a strategic plan for the improvement of quality systems based on the internal, customer, and regulatory audit observations.
• Coordination with the 'Regulatory Affairs' team to file the product in various regulatory markets.
• Handling of Vendor Management.
• Responsible for the monitoring of the Quality Management System.
• Review of product development reports, and coordinating for technology transfer for new and/or existing products to initiate process validation in sites.
• Review and approval of investigation reports, and to monitor the CAPA implementation progress.
• Handling of the change management system with a risk-based approach.
• Organizing and leading the Quality Review Board (QRB) meetings with all CFT members.
• Conducting the training on CGMP and functional as per training needs identification.