IT Quality Systems and CSV Specialist | Pharma (100% Remote)

IT Quality Systems and CSV Specialist | Pharma (100% Remote) Would you like to work in a global, multicultural team as " IT Quality Systems and CSV Specialist " for a committed international pharmaceutical company? If improving the quality and efficiency of IT systems and processes is in your DNA, we encourage you to sign up for this offer. TASKS & RESPONSIBILITIES🚀 : Ensure IT Quality & Compliance activities are effectively implemented and monitored across the global IT function. Support compliance with applicable regulatory requirements and corporate policies within the IT environment. Provide Quality & Compliance oversight for IT infrastructure qualification and computer system validation activities. Review and approve key SLC deliverables, including change controls, risk assessments, testing documentation, periodic reviews, and exception management. Ensure compliance with CSV, electronic records, electronic signatures, and data integrity requirements. Implement and monitor IT quality processes, including support during self-inspections. Collaborate with global Quality and Compliance teams to address business quality and compliance needs. Promote a culture of quality and compliance across the IT organization. Deliver GxP and non-GxP compliance training and drive awareness among IT personnel. Monitor adherence to corporate IT policies, procedures, SOPs, and work instructions. Coordinate and support internal and external IT audits and inspections. Conduct IT quality assessments and self-inspections, and monitor the effectiveness of CAPA actions. Provide proactive quality and compliance guidance to support validation and qualification activities. REQUIREMENTS 🤹: Fluent in written and spoken English. Master's degree in computer science, biotechnology or related field. Several years of experience with quality management systems (e.g. GAMP ) and IT standards (e.g. ITIL ). In-depth knowledge of the regulatory environment (e.g. GxP, audits) and information technology. In-depth knowledge of GxP-relevant IT processes and their support by computerized systems. Excellent communication skills, analytical thinking and the ability to work in a spirit of partnership. Ability to build consensus and influence decisions. SCHEDULE 🕘: From Monday to Friday: 08 am to 17 pm / 09 am to 18 pm (flexible) Possibility of 100% Remote work. BENEFITS 🌱: Salary package based on your profile. We will discuss it on our first call. Permanent Contract. Ticket restaurant included if you go to the office. Flexible Retribution Program (medical insurance, public transport ticket and childcare check). Discounts on gym network (Wellhub) Learning & Development. Our goal is that you are well in every way! Department IT Locations Sant Cugat del Vallès Remote status Fully Remote ​Trabajamos con los mejores profesionales del sector y lo hacemos de forma: