IT Quality Systems and CSV Specialist

🔥 11 minutes ago

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Ambit Iberia

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2003

💼 Consulting

🏥 Healthcare

Consulting • Healthcare

Ambit Iberia is a company specialized in providing digital solutions and regulatory and quality consulting services for the Life Sciences sector. The company offers a range of services including consulting in regulatory affairs, IT quality consulting, and the implementation of various ISO standards. With a strong focus on information technology, Ambit Iberia leverages its knowledge and experience to meet client needs in the rapidly evolving IT landscape.

📋 Description

• 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.

🏖️ 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!