Conduct research as per defined specifications and in line with all GMPGLP requirements to develop cost effective & eco-friendly processes of API for regulated less regulated markets within committed timelines and to generate data for regulatory filings.
Literature search, Scheme proposal and identification of KRM, Planning of experiment, develop cost effective, eco-friendly and scalable process with required quality.
Analysis of data and drawing conclusion.
Optimisation of process for process validation and scale-up to commercial batches.
Finalization of specifications of key intermediates and API after discussion with different department like RA, DQA and ARD.
Closely working with other departments like CFts to facilitate smooth functioning of the projects.
Implementation of effective safety, GLP regulation like compliance, data integrity and performance on execution.
Preparation of process package and development reports.
Transfer of technology to manufacturing for generation of launch and commercialization quantity for regulated less regulated market.
Support the RA for filing activisties and life cycle management of products filed.
Keyskills: Claims Process validation Legal Clinical trials Technical Lead Healthcare GLP data privacy data integrity GMP