Pharma IT Applications (R&D Clinical) - Turno nocturno

Pharma IT Applications (R&D & Clinical)Experience supporting and improving IT applications used in the pharmaceutical industry, both in research laboratories (R&D – Research & Development) and in clinical processes (such as clinical trials involving patients).These systems operate under strict regulatory requirements (GxP/GAMP5), meaning that all activities (usage, changes, data handling) must be controlled, documented, and auditable.🔹 Laboratory SystemsHands-on experience with systems commonly used in laboratories:LIMS (Laboratory Information Management System): software used to manage laboratory samples, test results, and associated dataELN (Electronic Lab Notebook): a digital notebook where researchers document experiments and findingsCDS (Chromatography Data System): software used to collect and analyze data from laboratory instruments (e.g., chromatography equipment)Typical responsibilities include:User supportIncident resolutionSystem maintenance and enhancements🔹 Clinical & Regulatory ProcessesUnderstanding of processes related to clinical studies and regulatory compliance:Clinical workflows: how clinical trials are managed (patient data, study tracking, data collection)Pharmacovigilance: systems used to monitor the safety of drugs, including tracking adverse effectsRegulatory tools: applications used to ensure compliance with health authority requirementsThe main goal is to ensure that all processes comply with strict pharmaceutical regulations.🔹 GxP Compliance & ValidationExperience working under regulated quality standards:GxP (Good “x” Practices): a set of regulations designed to ensure product quality, safety, and data integrity (e.g., GCP, GMP, GLP)GAMP5: a framework for validating computerized systems in regulated environmentsThis includes:System validation (ensuring systems work as intended and meet requirements)Change control (managing and documenting system changes)Quality assurance (ensuring compliance and audit readiness)🔹 Application Support & Continuous ImprovementProviding both functional and technical support for critical applications:Troubleshooting and incident resolutionProcess and system optimizationContinuous improvement of tools and workflowsAll within regulated environments where systems are business-critical and must meet strict compliance standards.LanguageSpanish | English Elementary