Deepranjan Mohanta Email & Phone Number

Kolkata, Wb, In

Hyderabad, Telangana, India

• SRC Medical devices vigilance regulatory FDA, EU, Australia, Canada and ROWreporting/submission.• Well-versed in SAP, E-submitter and other tools required for regulatory submission.• Post marketing surveillance for Philips SRC Medical devices.• Well-versed in regulatory submission guidelines and ISO 13485 QMS.• Submission of ISCR’s daily to FDA with 100% quality and productivity.• Well-versed in Power Bi and other tools for productivity and quality management.• Knowledge of Regulations/ guidance documents released by Health Authorities of different countries.

Kolkata, West Bengal, India

Quality Assurance Analyst• Ensure that all the cases being processed with 100% quality and submitted in a timelymanner without any Performing Quality Control Check on all type of cases in QMS TW toensure information reported to client is complete and accurate.• Perform weekly, monthly, and customer specific data trending and compile complaint datatables and/or graphs as required.• Evaluated, encoded, and maintained Quality Records based on the Product Issuesprocessed by the Complaint Evaluators / Investigators.• Good Understanding relationship between PFMEA and Quality Control Plan.• Prepared and produced cyclical reports pertaining to quartile movements, top defect analysis, coaching logs, minutes of meetings, gauge R&Rs, and processupdates.• Review trend analysis, Power Bi and ensure all KPIs for QMS.• Understanding Differences in EU and US Regulations, Understanding Differences in USandEU Adverse Event Reporting.L1 Investigator/ evaluator• Processing of adverse event reports from Spontaneous, Health Authority, LicensePartner, Patient Oriented Program, Post Market Surveillance, and CAPA Analysis.• Experienced in data entry and investigates customer complaints, makes initial reportingdecisions, facilitates investigations and ensures consistency and completeness of thedocumentation for complaints.• Responsibility for day-to-day processing complaints from all Global locations. • Ensurecomplaints are processed thoroughly and timely in compliance with departmentalprocedures.• Perform preliminary classification of complaints, follow up with customers for requiredinformation and product returns, maintain complaint records and all supportingdocumentation, assign additional actions as necessary to close complaint.

Kolkata, West Bengal, India

• Risk assessment and coding of patient records under RTI hospitals:• Responsible for determining severity level of the patient records and codingthemaccording to their severity.• Responsible for provider coding and procedure coding.• Knowledge of ICD10 disease coding and was responsible for ICD10 diseasecoding in the records.• Responsible for Client specific training, maintained quality, timelines, exceptionalproductivity as per regulatory guidelines in medical and hospital coding.

Bachelor Of Pharmacy - Bpharm, Pharmacy, Pharmaceutical Sciences, And Administration, 7.7

Activities and Societies: played for my college football team

Bachelor Of Pharmacy - Bpharm, Pharmacy, Pharmaceutical Sciences, And Administration

B.Pharm, Bachelors

Master Of Business Administration - Mba, Operation Management & Leadership