201320-Quality Management System Specialist

Support the QMS of VaxThera Rionegro, executing activities that facilitate a culture of quality, proactive risk management and continuous improvement, by preparing data, reporting on quality events, metrics and ensuring everyone is committed to quality principles and SOPs compliance.
Prepare trend reports of change controls, deviations, CAPA, QRM Support processes and send reminders to the person responsible for open complaints, change controls, deviations, CAPA, QRMReport complaints to the appropriate personnel to take corrective actions as neededMaintain records and data bases for deviations, change controls, complaints, risk assessments and the associated corrective actions takenExecute QMS related activities to comply with relevant regulations like cGMP, internal quality standards and other applicable regulationsSupport in periodic gap analysis to identify areas where current QMS practices might not meet regulations or require improvementExecute internal reviews to assess the effectiveness of the QMS and identify any deviations from proceduresReport key performance indicators (KPIs) related to QMS and identify areas for improvementParticipate in the execution of product recall drills to ensure the company is prepared for a real recall situationLEVEL EDUCATION/ NIVEL EDUCATIVO
Professional graduateAREA OF STUDIES/ÁREA DE ESTUDIO
Professional in Sciences (Life Sciences), Engineering, Chemstry, PharmacistOTHER KNOWLEDGE/ OTROS CONOCIMIENTOS
StatisticsComputerized systemsKPIsYEARS OF EXPERTISE/AÑOS DE EXPERIENCIA
2 years or moreAREA OF EXPERTISE/ ÁREA DE EXPERIENCIA
US FDA, EMA guidelines, QMS, WHO guidelines, documental management system.LANGUAGE / IDIOMA
EnglishLEVEL / NIVEL
B1
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