Elaine Alves

Review, preparation and approval of operational procedures. Analysis of manufacturing and packaging dossier and their approval or rejection via SAP. Accomplishment of self-inspection according to GMP. Research about deviations and treatment of non-compliance. Analysis of results sent by Quality Control. Monitoring of manufacturing batches in development and revalidation. Elaboration of risk analysis and validation protocol.

Knowledge of processes and equipment of solid, semi-solid and liquid formulations. Preparation of post-registration documentation. Analysis of legislation and national and international literature (WHO). Development and critical analysis of formulations, including evaluation of test results reported by the analytical development. Intern project : „ Mapping of raw materials and indication tests for approval of Galenic Development “

Quality control tests of excipients and active pharmaceutical ingredients (API). Manipulation of solids, semi-solids and liquids formulations. Proper guidance on rational use of medicines (dispensing).