Technology Capital & Services - Quality Specialist Lazio

Technology Capital & Services - Quality Specialist
Roma
Lazio, Lazio

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 Technical Departments (Equipment Qualification/Calibration 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.

- Collaborate with the Team Leader to identify and solve the quality gap of Technical Departments.

- Support the Team Leader in preparing in Customer Audits and Regulatory Inspections.

**How will you get here?

- Technical / Scientific Degree (Mechanical Engineering, Chemical Engineering, CTF, Biomedical Engineering, Pharmacy, Industrial Chemistry)

- Experience in pharmaceutical industries

- Preferable 6 months experience in one of the following Departments of Pharmaceutical or Consultant Company: Qualification, Calibration, Engineering or Maintenance

**Knowledge, Skills, Abilities

- Knowledge of the main pharmaceutical machines/systems

- Good in English

- Good Team-worker

- Good problem-solving abilities

- Proficiency in Microsoft Office suite