Must have excellent skills and knowledge of bioanalytical sample processing techniques. Very good understanding of current bioanalytical guidelines of various regulatory agencies such as USFDA, ANVISA, ICH etc.
GPAT is a national level examination for award of scholarship to qualified candidates seeking entry into Master of Pharmacy (M. Pharm) course. The first GPAT was conducted in the year 2010 and thereafter it is conducted every year till 2018 by All India Council for Technical Education (AICTE) as per the directions of Ministry of Education, Government of India and from the year 2019, the examination is conducted through the National Testing Agency (NTA) as per the directions of Ministry of Education, Government of India to till 2023.
Compilation and review of product license applications, variations, and renewals for Mexico or ASEAN countries as per regulatory requirements respectively with minimal supervision. Manages electronic documents and creates electronic submissions in CTD format.
Review of various formulation and packing development, technology transfer documents like but not limited to Master Formula, Master Formula Card, Product Development Report, Dissolution Development report, Elemental Impurity Risk Assessment Report, Stability plan, QbD based Risk Assessment report, Failure Mode Effect Analysis, Process Validation Protocol
After a journey of growth spanning 27 years as Cadila Healthcare Ltd. and the Zydus Group, we have evolved and transformed ourselves in response to the changing times.
Should demonstrate a strong understanding of B2B business dynamics and have independently managed and traveled across these regions. A solid grasp of business contracts, along with excellent negotiation skills, is essential.