Simone Mazzolini

I assure that the site quality systems are aligned with the applicable regulations, quality unit's purposes and with the organization's strategic direction.

I manage the core of policies, processes, systems and resources needed to implement and maintain key quality management goals. I coordinate a team of QA people.

Main activities and responsibilities:

• Equipment Qualification;
• Cleaning Validation;
• Computer System Validation;
• Change Control Management;
• SOPs Management;
• Employee Training;
• Continuous Improvement;
• Risk Management;
• Project Management.

I've been the primary point of contact for quality matters that arise from Customers.

I oversighted Qualification activities and IT Validation activities. I ensured that Company complied with applicable regulatory requirements and industry standards relating to hardware qualifications and software validation and controls.

Main activities and responsibilities:

• Equipment Qualification;
• Cleaning Validation;
• Computer System Validation;
• Change Control Management;
• Technical Support;
• Process Validation;
• Risk Management;
• Project Management;