JOB DESCRIPTION We are hiring! We are looking for a Qualified Person for our Siziano Office.
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 additions) and as Responsible Person at the pharmaceutical site. The resource will be in charge of the following tasks:
1. Manage training and audit programs;
2. Ensure that relevant customer complaints are dealt with effectively;
3. Manage qualification of suppliers, system and equipment;
4. Manage returned, rejected, recalled or falsified products;
5. Manage the right identification, investigation and reporting of compliance issues, irregularities, and he violations;
6. Approve and manage CAPA Plan implementation;
7. Assure that temperature monitoring of warehouse and critical systems are GXP compliant;
8. Assure that procedures and operating instructions are updated, approved and available in support to all processes;
9. Participate in the review of the processes, pushing towards the innovation of the entire quality process;
10. Support in the preparation of documentation for AIFA and other regulatory bodies new applications;
11. Management of psychotropic drugs according to. 309/90 and subsequent amendments and additions. He/She will assure availability of Import/Export permits according to Customer's requests; He/She will assure that any mandatory notifcation will be appropriately and on time sent to the Ministry of Health;
12. Ensure that a quality management system is implemented and maintained compliant with the current site authorizations and any additional requirements imposed on certain products by national legislation.
Your Skills and Experiences
13. Bachelor's Degree
14. Experience in Quality Assurance (QA)
15. Experience in the Logistics field
16. Knowledge of quality management system procedures
17. Familiarity with ISO, GDP, and GMP standards
Good Reasons to Join
Since its foundation in 1890, Kuehne+Nagel has been committed to deliver its services with the highest standards to customers and communities, creating a tradition of excellence. Today, we are the #1 player in Logistics worldwide, with 1.400 location and 78.000 employees in 100+ countries. The Italian branch has 50+ years of activities and counts 40 locations with 3.000 team members partnering with more than 3000 clients. As a global organization, Sea, Air, Road and Contract Logistics are the four pillars of our business. As all Business Units strive to innovate while keeping a sustainable business outlook, we seek for drive & ownership in all our candidates. Passion & willingness to be part of a multicultural and dynamic team are a must to us! We care about our people as much as we do for our customers: we inspire our colleagues to act according to their uniqueness, empower them to own their career path, delivering the best balance between performance and individual wellbeing. Your contribution will always matter. What we offer: We strive to provide you and your loved ones with a first-class benefits experience, focused on supporting your physical, financial, and emotional wellbeing. Our benefits are centered around you and your family, our offer is constantly improving: - Accidental coverage (at & outside work) - Extra Medical insurance - Full access to Fitprime for you and your friends: access to +3000 Gyms, pools and sport centers + Online workout (. yoga, mindfulness, cardio) + nutritionist - Speexx, your digital coaching platform for language training – For you and someone of your choice - 5 extra days of paternity leave - Remote working enhancement for new parents - 1 day off for volunteering activities - Free Tax return support (730) - Free social welfare consulting (. INPS, disability, pension) 1000+ discount on products and services - Special discount on travels with Interline Turismo