Aamir Sohel

Background

About Aamir Sohel

Conduct experiments on concepts to achieve target goal required for the feasibility of the assigned projects. Prepare/Review required process documents for the regulatory submission such as QMS documents as per ISO 13485, 21 CFR 820, MDR/SOR 98/282 etc. Raw material identification, procurements and perform necessary process on material, Verify all batch manufacturing record & raw material stock for the assigned projects. To verify/validate new process or modify existing process required for development of assign projects. To conduct biocompatible (preclinical) and clinical study as per the guidelines. Draft patent write-up for the assign projects. Communication with other department for product transfer, accessories, equipment/instrument selection for process development of R&D projects. Project Plan and Transfer Master Plan: how to document the transfer activities. Responsible for the accountability of sub-ordinates and their work on assigned projects. Responsible for proper implementation of QA & RA related system in assigned projects.