shravan dubey

Jhalawar Area, India India

Pharma API proffesional

Medical / Health Care / Pharmaceuticals

I have Eight year experience in API Industry Initial two year i was worked in production department (Indo swift and Teva API) and after that i joind in Quality Assurance department and now working as an SR. EXECUTIVE QUALITY ASSURANCE in ALEMBIC PHARMACEUTICALS LIMITED at Vadodara, During my eight year of experience i have faced some regulatory audits as a key performer like USFDA, TGA, KFDA, local FDA and aproxx 200 customer audits. Currenlty i am handling CAPA management, Quality risk assessment (ICH Q9), Quality managemrnt review (ICH Q10), market complaint and customer compliances individually. I am also supporting to establishment in process validation anf cleaning validation, OO...