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 integral 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!

📌 IT Quality Systems and CSV Specialist | Pharma (100% Remote) (San Cugat del Vallés)
🏢 Ambit Iberia
📍 San Cugat del Vallés