Tehničar u odjelu kvalifikacija (m/f/x)

About the role

The Qualification Department Technician will support a wide range of activities ensuring that equipment, systems, facilities and utilities meet GMP standards throughout their lifecycle. This position works in a regulated pharmaceutical environment, collaborating with production, laboratory, warehouse and logistics teams.

Key responsibilities

• Carry out qualification activities for equipment, systems, spaces and utilities in a GMP setting.
• Participate in planning, coordinating and executing IQ, OQ, PQ and re‑qualification projects.
• Prepare, review, revise and issue qualification documentation such as plans, protocols, reports and work instructions.
• Monitor qualification status, manage re‑qualification deadlines and ensure compliance with regulatory and internal requirements.
• Support new projects, equipment start‑up, change control and implementation of modifications.
• Investigate deviations, conduct root‑cause analysis and follow up on CAPA actions.
• Calibrate and install data loggers for temperature mapping of rooms, chambers and refrigerators.
• Analyse qualification test data and produce technical reports.
• Assist in internal and external audits and regulatory inspections.
• Stay up‑to‑date with GMP guidelines (HALMED, EMA, FDA, EU GMP, PIC/S) and apply good documentation practice.

Required profile

• Technical or natural science degree (SSS/VŠS).
• Experience in pharmaceutical, biotech or related industry is desirable.
• Familiarity with GMP principles and quality systems is a plus.
• Knowledge of production equipment and qualification/validation processes is advantageous.
• Proficiency with MS Office.
• Active knowledge of English (spoken and written) is preferred.
• Independent, precise, organized and willing to continuously improve.
• Valid driver’s licence category B.

Required skills

• GMP principles
• IQ/OQ/PQ qualification methodology
• CAPA (Corrective and Preventive Action) processes
• Calibration of temperature data loggers
• MS Office suite