Quality Qualification Specialist

4 settimane fa

Ferentino, Italia Thermo Fisher Scientific A tempo pieno

**How will you make an impact?**

Ensure the Quality of the Technical Area Departments, dealing in particular with the management of Customer Audits and Regulatory Inspections, Deviations, CAPAs, Changes, SOPs relating to Process Maintenance and Utilities, Calibrations and Equipment Qualification.

**What will you do?**
- Support the Quality Department in preparing, managing and actively participating in Customer Audits and Regulatory Inspections.
- Support the Technical Departments (Equipment Qualification and Maintenance) in increasing their Quality Culture, helping them with Deviations, CAPA, Change, SOP, Training, Risk assessment and Data Integrity.
- Analyze the historical data and results of the qualification and maintenance activities.
- Assure the protocols, reports and SOPs are in compliance with current regulations (current EU GMP, US GMP) and company quality standards.
- Participate in calls/meetings with customers/auditors to support the discussion on quality topics for Technical Departments.
- Collaborate with the Team Leader to identify and solve the quality gap of Technical Departments.

**How will you get here?**
- Technical / Scientific Degree (Mechanical Engineering, Chemical Engineering, CTF, Biomedical Engineering, Pharmacy, Industrial Chemistry)
- Experience in pharmaceutical industries including Audit/Inspection participation
- At least 2 years’ experience in Validation or Quality Department

**Knowledge, Skills, Abilities**
- Knowledge of the main pharmaceutical machines/systems
- Fluent in English
- Good Team-worker
- Good problem-solving abilities
- Proficiency in Microsoft Office suite and electronic systems such as Documentum and Trackwise
- Be prepared to work with conflicting priorities, under time constraints and in a dynamic team environment

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