Prabhu Dhanapal

Experience

1. Team Leader (Post Market Surveillance)

   Wipro

   Feb 2024 — Present · Kolkata, IN

   Preparing reports for assignation and assigning complaints to the team based on the requirements.* Evaluating incoming complaints and maintaining records in the electronic QMS database.* Performing Good Faith Efforts (GFE) when required to gather additional information as needed to support the investigation process.* Investigating the complaint to write DHR, CHR, Risk review results, and investigation summariesbased on the technical product analysis reports.* Determining the complaint\'s reportability and submitting reports (MDR – Medical Device Reporting) to the respective regulatory bodies when the complaint is reportable.* Creating and submitting supplemental MDR to the US FDA if required.* Preparing and maintaining the defect tracker for monitoring the quality of the complaints and taking necessary actions if the quality is getting down.* Monitoring and maintaining KPI’s (Productivity, Quality and TAT) based on project requirements.* Organize required training and information-sharing meetings to update the team members\'process knowledge.* Supporting for preparing billing details.* Monitoring individual’s performance and improving their weaker areas.* Preparing the analysed report to the Project Manager and client for better visibility of the complaint’s quality.

Education

• Velalar College of Engineering and Technology

  BE - Bachelor of Engineering

  2015 — 2019