Sk Morsadul A.

I am a Pharma Graduate, having 10 years of experience in ISO 13485, Validation, CSV, Manufacturing, Contract manufacturing, SOP, Documentation, regulatory affairs, GMP a Currently, I am working as a Project Manager in a Pharmaceutical MNC. ☆Key skills: Pharmaceutical Medical device Standard operating procedure Contract manufacturing 21 CFR Part 11 compliance. GxP Compliance CTD dossiers, eCTD dossier, DMF writing (in Pharma). Preparation of regulatory submissions of medical devices, Maintain compliance of company with ISO 13485 and 93/42/EEC and 21 CFR 820 regulations and guidelines.