Quality Assurance Specialist – Computer Systems Validation
Do you want to join a global biotechnology company? In BioSystems, we design, develop, produce, and market analytical solutions for five biotechnological areas:
* Clinical Analysis
* Veterinary Analysis
* Food & Beverage Analysis
* Agricultural Analysis
* Bioprocesses Analysis
We 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 week
* Location: Barcelona, Sant Andreu district
* Immediate start
* Company environment that encourages innovation, teamwork, personal and professional growth
* Permanent contract
BioSystems
human-centered biotech
(+34) 933 110 000 #J-18808-Ljbffr