Full-time Analyst Quality Assurance
Althaia SA Pharmaceutical Industry
Althaia Pharmaceutical Industry
Brazil
Activities: Experience in Pharmaceutical industry in the areas of Analytical Development and Quality Assurance. In the analytical development I started as responsible for the performance of the dissolution profile, dosing and other tests of the products under development and operation of HPLC (UV, DAD and fluorescence) equipment and spectrophotometer, using Ezchrom software. Compilation and discussion of the results of tests carried out on products in development and reference medicine. Experience in analysis of Pharmaceutical Equivalence. Currently in the Quality Assurance as the main activity I carry out investigations of internal quality misconduct related to several areas (production, warehousing, analytical development and quality control) outsourcing customer complaint and market complaint reported by SAC, in partnership with the areas involved propose actions to avoid recurrence and improvements. Balance of Controlled Medicines BSPO, ordinance No. 344. Elaboration of Periodic Product Review Other related activities: Contact with Qualification of equipment and accomplishment of Process Validation and Holding Time (validity study). Execution and evaluation of actions and proposals established in the Controls of Changes. Annual elaboration of the Periodic Review of Water, with evaluation of results trends. Elaboration of the Periodic Review of Environmental Monitoring Results, evaluating the trends. Documentation and batch release revision. Elaboration of Quality Assurance Procedures and revision of Procedures in other areas; Internal audit. Experience with the SAP system. Basics of registration and outsourcing contract.
Medicine