Quality Assurance Specialist

Quality Assurance Specialist – Computer Systems ValidationDo you want to join a global biotechnology company? In BioSystems, we design, develop, produce, and market analytical solutions for five biotechnological areas:Clinical AnalysisVeterinary AnalysisFood & Beverage AnalysisAgricultural AnalysisBioprocesses AnalysisWe look for a person with customer service orientation, analytical skills, proactive, autonomous, decisive, goal-oriented, who likes teamwork, and has a great ability to adapt to change.Responsibilities:Work in the Quality Assurance – Regulatory Affairs Department, in a company with a Quality Management System certified under ISO 9001 and ISO 13485 and IVD Regulation compliant, helping to maintain and improve this Quality System.Plan and document computer systems validation activities, according to international standards (ISPE GAMP5, ISO 80002-2, etc., FDA).Implement new Regulations/Standards applicable to our Quality Management System, especially the ones related to IT Systems.Get involved with all the processes and prepare and maintain related procedures.Requirements:Bachelor's or master's degree with a major focus on IT, engineering, sciences, pharmaceuticals, or biotechnology (or an equivalent field).Experience in computer systems validation (ERP, eQMS).High adaptability to changes and constant evolution.Fluent English.We will value experience in Quality Management System, ISO 9001, ISO 13485 and SAP S4HANA skills.We offer:Full working day in a global company in the Biotechnology sector, whose mission is to contribute to improving health and wellness by providing analytical solutions designed to offer a good user experience.Flexible schedule, 39 hours per weekLocation: Barcelona, Sant Andreu districtImmediate startCompany environment that encourages innovation, teamwork, personal and professional growthPermanent contractBioSystemshuman-centered biotech(+34) 933 110 000
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