Udai Pratap Singh
Manager - Quality Assurance @Medsource Ozone Biomedicals Pvt. Ltd
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WORK HISTORY
Manager - Quality Assurance @Medsource Ozone Biomedicals Pvt. Ltd
Faridabad, IN
Implementation of ISO 13485 (QMS), ISO 14971 & 24971 (Risk Management), ISO 20416 (PMS). Technical Documentation as per IVDR with sound knowledge of GSPR, Risk Analysis, Performance Evaluation, Labelling, IFU, Post-Market Surveillance, Post-Market Performance Follow-Up (PMPF), Vigilance and Periodic Safety Update Report (PSUR). Also involved in Complaint Handling, conducting Internal Audits and managing the External Audits by Regulatory Authorities/External Auditors.
EDUCATION
Amity University, Noida
Ph.D. (Biotechnology)
Amity University, Noida
M. Tech. (Biotechnology)
St. John's School, Mahrauli, Varanasi, Uttar Pradesh, INDIA
12th Standard
Amity University, Noida
B. Tech. (Biotechnology)
St. John's School, Mahrauli, Varanasi, Uttar Pradesh, INDIA
10th Standard
ABOUT UDAI PRATAP SINGH
Capable of working in challenging environments with high level of commitment for tasks…
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