Quality Assurance Specialist

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
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