API ADL Analyst

Job Purpose

Provide analytical support to API R&D, Regulatory Affairs, Manufacturing units and other analytical laboratories by method development of raw materials, intermediates and final API in order to ensure the drug development is carried out as per the project timelines and adheres to all regulatory requirements

Accountabilities

I. Provide method development and routine analysis under GLP environment to finalise the specification for standardization of the molecule and for final DMF submission
II. Investigate plant queries like OOS, OOT for quality control of drug substance and products in order to provide corrective actions and check samples for impurities
III. Characterise final API and impurities to prepare the test or working standards for routine laboratory purpose
IV. Conduct the incubation and perform complete analysis of stability samples to conclude the storage, shelf life and packing conditions of the final API
V. Keep track of the latest innovation and applications which can be used with the existing techniques to investigate / resolve critical issues

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