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 integral 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 Gx

📌 IT Quality Systems and CSV Specialist | Pharma (San Cugat del Vallés)
🏢 Ambit Iberia
📍 San Cugat del Vallés