Thorough knowledge of EU, MENA and ASEAN markets country requirements, regulatory affairs procedures for initial submission, licensing, post-approval submission management
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.
Production QMS Quality Management System Handling of QMS activities like Deviation, Incident, Investigation, CCP, Protocol Preparation, Risk Assessment etc.
A Masters M.Pharm or M.Sc. or M.Tech. or M.E. or Bachelors B.Tech or B.E. or B.Pharm. An understanding of the Process Development and Industrial perspective of Biotherapeutics/ Biosimilars. Basic understanding of analytical techniques, statistical analysis, data management and analysis.
Exposure of Waters HPLC, Dissolution, GC and other Instruments with AMV, RM, PM, FP product analysis Handling of QMS related Activities Exposure of various instruments/ software like Empower 3, LIMS and other softwares
Candidate should have knowledge of manufacturing operations of granulation, compression, coating and capsule filling, responsible to adherence cGMP guidelines. USFDA, MHRA exposure is must.
Gracure Pharmaceutical Ltd. is a Delhi based pharmaceutical company, established in 1992 by Mr. A.S Bhargava with the vision of making world class affordable medicines.