Qualification & Validation Specialist

01 ago - Italia
Experteer Italy

Experteer Overview In this role, you will lead qualification and validation activities within the Quality Unit to ensure GMP‑compliant equipment, processes, and systems. You will design and execute qualification plans, draft and verify VMPs and validation documents, and support calibration and maintenance activities. You will work cross‑functionally to drive continuous quality improvements and ensure robust validation of HVAC, water systems, and process gases. This is a hands‑on position at a biotech company that values quality, compliance, and operational excellence.Retribuzione / Benefits
- Manage qualification plans and written procedures
- Draft, verify and execute qualification protocols and tests (FAT, SAT, IOQ, PQ)
- Perform validation test runs and related activities
- Draft and monitor VMP activities




- Support qualification activities for equipment and utilities (HVAC, water systems, process gases)
- Support Maintenance with calibration and maintenance plans/instructions
- Facilitate continuous improvement in quality-related matters

Responsabilità
- Degree in Engineering, Chemistry, Biotechnology, Pharmaceutical Chemistry and Technology, or related field
- 3–4 years of pharmaceutical industry experience
- Knowledge of GMP
- FMEA, HACCP or other risk‑based methodologies
- Knowledge of validation/calibration instruments and validation procedures (VMP, FAT/SAT, IQ, OQ, PQ)

Requisiti fondamentali
- Salary package 35,000–45,000 EUR per year
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