Core Job Responsibilities
Development of formulation using scientific rationale in use of excipients to create a reproducible prototype formulation.
Ensure Proper documentation of every trial in the log note books and then using the information for creation of the Product Development Report for use in dossier for filing.
Use of QbD wherever required for Product and process optimization.
Ensure proper upkeep, maintenance and calibration of the equipment.
Ensure scale up of the developed formulation works at engineering batch level.
Development of the patent non-infringing strategy for product development.
Preparation of regulatory documents for PK study and marketing approval from DCG (I).
Preparation of Pharmaceutical Development report for Quality module of CTD.