ABOUT US:

We are dedicated to the research, design, validation, manufacture and distribution of
anti-allergic vaccines (immunotherapy sector).

We have a Technical, R&D; and Clinical Trials headquarter in Zamudio, our only production centre for the moment. In this sense, we have a
strong growth forecast.

Our value proposition for employees
is as follows:
- PEOPLE-CENTRIC: We focus on people.
- SELF-DEMANDING PEOPLE: We promote individual self-demand in pursuit of common achievement.
- CURIOUS PEOPLE: We learn by innovating, valuing the experience that each person can bring to the organisation.

ABOUT THE JOB:

We are looking for a
Qualifications and Calibrations Technician
to join our team. He/She will report to the Head of Engineering and Maintenance and will provide support to the group within the Industrial Area.

Mission.
Coordinate and ensure the correct execution of qualification and calibration activities for critical equipment, facilities, and services carried out by external suppliers, guaranteeing compliance with Good Manufacturing Practices (GMP/BPM)



and applicable regulatory requirements. Be the technical manager of the plant's qualification and calibration plans.

Main tasks and responsibilities:
- Plan, coordinate and monitor qualification (IQ, OQ, PQ) and calibration activities carried out by contractors and external laboratories.
- Ensure that activities are carried out in accordance with internal procedures, master plans, schedules and regulatory standards.
- Technically validate protocols, reports, certificates, and documentation provided by suppliers, ensuring their integrity, traceability, and compliance.
- Keep Qualification and Calibration Plans and associated schedules up to date.
- Coordinate interventions with different areas of the company to minimise the impact on operations.
- External supplier management, documentation validation (protocols, certificates, reports) and management of deviations, changes and CAPAs.

Requirements:
- Degree

📌 Qualifications and Calibrations Technician (Zamudio)
🏢 Roxall Medicina España
📍 Zamudio