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 general 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 kn

📌 IT Quality Systems and CSV Specialist | Pharma (Barcelona)
🏢 Ambit Iberia
📍 Barcelona