Moumita Mitra Email & Phone Number

I am a Senior Associate at Wipro Digital Operations and Platforms in the MDPS domain. My current position as a Quality Analyst is to check, detect and prevent the errors that may have occurred by the production team. I am also involved in initiating, updating, processing and maintaining device-tracking files in the system. As a medical device tracking analyst for Tier III devices, my ultimate goals reside in recording and reporting all potential product complaint activity to the intended regulatory body, following complaint handling regulations 21 CFR 820.198 & SOR/98-282 and established procedures. As SPOC for a team of 33, I am also involved in team management, task dividing and providing ongoing training and re-training on company policies, device tracking regulations, and complaint handling procedures.Previously, I was also involved in managing an Electronic Trial Master File (eTMF) and ensuring its accuracy, completeness, and timeliness. This project also demanded reviewing and categorising eTMF documents according to established criteria, ensuring compliance with ICH-GCP guidelines and regulatory requirements while maintaining Essential Document Lists for clinical trials.