Competent in Analytical methods validations and transfers of Drug substances and Drug Products. Experience in drafting investigation reports and protocols
Batch Disposition post reviewing the batch manufacturing, packing, and testing records assuring compliance with established SOPs, specifications, and standard formats and ensures that all investigations related to batch are closed prior to the batch disposition.
Experience in reviewing specifications and STPs, ensuring data integrity, proposing QbD Quality by Design process changes, and participating in phase gate reviews
Candidate should have knowledge of manufacturing operations of granulation, compression, coating and capsule filling, responsible to adherence cGMP guidelines. USFDA, MHRA exposure is must.
Granules India is a vertically integrated, high-growth pharmaceutical company with 38 years of proven performance and increasing performance and increasing presence across the world.