PHARMACEUTICAL DEVELOPMENT TECHNICIAN

Insud Pharma is a recognised and respected company in the pharmaceutical and healthcare sector with more than 40 years of history and more than 7,000 employees in 50 countries specialising in the research, development, manufacture and marketing of active pharmaceutical ingredients and medicines for human and veterinary use.Chemo, industrial area of the Insud Pharma group, is a world leader in R&D and manufacturing of more than 100 value-added active pharmaceutical ingredients and more than 122 medicines with more than 200 different product presentations. Chemo produces its own active pharmaceutical ingredients (API) as well as finished pharmaceutical products (FDF) covering the main therapeutic groups (Cardiology, Gastroenterology, Central Nervous System, Anti-infectives, Respiratory, Women's Health, Endocrinology, Dermatology and Urology).COMMITMENT TO EQUAL OPPORTUNITIESInsud Pharma is aware that business management has to be in line with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as stated in the current legislation on the subject - Organic Law 3/2007, and we do not discriminate against any person on grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.OverviewSupervise, organize, review, and evaluate the development and optimization of formulations and galenic processes, avoiding patent infringement, ensuring the maintenance of necessary stock, and preparing documentation (guides, manufacturing orders, protocols, information letters, proforma invoice, etc.) and the preparation of medicines for clinical trials; and, once these clinical trials are completed, provide the necessary documentation to the Regulatory Department; in accordance with PNT, GMP, and GLP regulations, and the guidelines of the European Pharmacopoeia and the USP direct superior; in order to conduct bioequivalence tests and studies and submit the drug dossierResponsabilitiesDevelop and test standard operating procedures (especially equipment operation), protocols, specifications, guidelines, and documentation for GMP release necessary to conduct scheduled tests in the department and clinical trials.Organize and monitor the work of operators to carry out the established schedule.Characterize the reference product, search literature, review and evaluate patents to develop products.Make requisitions and maintain stock control according to forecasts to conduct various tests.Receive results from the operator of the different galenic tests to file, analyze, prepare reports, dossiers, and propose to the supervisor tests to improve results, optimize processes and formulations, and facilitate decision-making.Train new galenic operators in machine handling, address area questions regarding daily operation, and monitor proper functioning during the commissioning of new equipment and compliance with the existing Calibration Plan to ensure compliance with GMP procedures and regulations.QualificationsEducation: Degree in Pharmacy.Languages: Fluent in Spanish and English, knowledge of other languages is valued.Experience (years/area): 2-5 years of experience as a Formulation Technician (or similar) in the Pharmaceutical Industry.Specific Knowledge: Experience in a GMP environment, knowledge of FDA is a plus.Travel: Not required.Personal skills: Good analytical ability, precision, and reliability.