Qualified Person

Your Role

The quality assurance of pharmaceutical products is ensured through thorough controls and constant monitoring. The resource will be embedded in a very technical and professional pharmaceutical quality team, will be provided with support in daily activities, and will be trained to become part of the Healthcare Kuehne Nagel Community. In addition to carrying out day-to-day activities, the resource will also actively participate in the review of processes and their innovation.

Your Responsibilities

The resource should be eligible to be named as Qualified Person (Dlgs 219 / 2006 and subsequent amendments) and as Responsible Person at the pharmaceutical site. The main tasks include :

• Manage training and audit programs;
• Ensure effective handling of relevant customer complaints;
• Manage qualification of suppliers, systems, and equipment;
• Manage returned, rejected, recalled, or falsified products;
• Identify, investigate, and report compliance issues, irregularities, and violations;
• Approve and implement CAPA plans;
• Ensure temperature monitoring of warehouse and critical systems complies with GXP;
• Update, approve, and ensure availability of procedures and operating instructions;
• Participate in process reviews and drive quality process innovation;
• Assist in preparing documentation for AIFA and other regulatory bodies;
• Manage psychotropic drugs according to D.P.R. 309 / 90 and amendments, ensuring import / export permits are available and notifications sent to the Ministry of Health on time;
• Implement and maintain a quality management system compliant with site authorizations and legislation.

Your Skills and Experiences

• Bachelor's Degree
• Experience in Quality Assurance (QA)
• Experience in Logistics
• Knowledge of quality management systems
• Familiarity with ISO, GDP, and GMP standards

Good Reasons to Join

Since 1890, Kuehne+Nagel has committed to delivering high standards of service. Today, we are the leading logistics provider worldwide, with over 1,400 locations and 78,000 employees across more than 100 countries. The Italian branch has over 50 years of activity, with 40 locations and 3,000 team members serving over 3,000 clients. Our core business pillars are Sea, Air, Road, and Contract Logistics. We foster innovation and sustainability, seeking candidates with drive, ownership, and a passion for working in a multicultural, dynamic environment.

We value our people and support their wellbeing through comprehensive benefits, including :

• Extra Medical insurance
• Access to Fitprime (gyms, pools, online workouts, nutritionists)
• Speexx language training platform
• Additional paternity leave
• Remote work support for new parents
• Volunteer day off
• Tax support and social welfare consulting
• Product and travel discounts

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