Galenic Researcher SR - QbD

Job description

RESPONSABILITIES AND ATTRIBUTES Development and post-development of products with a focus on international protocol (Europe and United States), through research at reliable sites, literature, official compendia, studying and analyzing, when applicable, the reference medication, with the aid of analytical tests and pre-formulation tests, using bench tests to obtain a product with satisfactory physical-chemical results through a viable production process, fulfilling requirements and ensuring compliance with regulatory agencies, such as FDA and EMA, in order to ensure the quality, safety and efficacy of the final product.

Required skills

research ema fda sites europe protocol regulatory agencies production process literature united states analytical tests qbd compendia reference medication pre-formulation tests bench tests

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