Global Responsibility As part of the pharmaceutical development group, support the development of drug products with the aim of its registration and commercialization by conducting the analysis and characterization of raw materials (API, excipients and packaging materials), process intermediates, finished products and reference products.
Follow the methodology, evaluate and report the results obtained according to the stage of the development and to the quality system and GMP rules.
Specific Responsibilities Assign all samples with an ID according to the SOP to ensure sample traceability.
Development, verification, validation and analytical method life cycle improvements for raw materials, intermediates and finished products.
Analytical results evaluation and reporting according to GMP.
Understand, train and follow SOPs for all activities.
Inform, investigate and document OOS, OOT and anomalous results in a timely manner.
Use equipment according to SOPs and perform internal calibrations when required.
Review, update and maintain stock levels for lab materials, consumables, reagents, standards, reference products and any other materials.
Work safely, in an orderly and clean manner and at all times following laboratory SOPs.
Verify the work done by peers to ensure compliance with GMP documentation principles.
Requirements Education: University degree in science (Chemistry, Pharmaceutical or equivalent) or technical Lab training module.
Languages: High level of Spanish and preferably medium level of English Experience (years/area): Minimum 1 years' experience in the functions mentioned above as analyst in the pharma industry.
Specific Knowledge: Liquid Chromatography, (hands on), other common lab analytical techniques (GC, KF, thermal analysis, etc).
General pharmaceutical guidelines, GMP