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Quality Assurance and Regulatory Affairs Manager Italy (m/f/d) Milan

Italy, Lombardia, MilanoQuality Management & Continuous Improvement

Your Tasks

Are you ready for a new challenge? For our location in Italy, in Settala (Milan) we are looking for a Quality Assurance and Regulatory Affairs Manager (m/f/d).

About the role

We are setting up our new facility in Milan and in this role you will be responsible to implement the central quality policies in this new Italian site (QMS, ISO/GDP, HACCP, supplier management, risk management, audits, etc.).

Your tasks

  • You make sure that the quality management system is aligned with the central quality system of our headquarter located in Sevenum, the Netherlands.
  • You will perform internal audits and guide external audits of national authorities and implement improvement actions.
  • You will support in requesting the right licences from a pharma compliance point of view, in collaboration with our legal department and pharma compliance department.
  • You will assess products in case of damages, temperature deviations, recalls and suspects of falsifications in cooperation with our Italian pharmacists.
  • You play a key role in building a quality culture in our new site.
  • You are responsible to align with management of logistics, facility and procurement in order to make sure that all quality related norms are implemented.
  • You make sure that quality procedures are followed by the employees.
  • You also make sure that each employee is trained in relevant quality guidelines (GDP, dangerous goods, organic products, etc.).

Your Profile

Your profile

  • You have an educational background in Health Science, Pharma Assurance or Quality Management.
  • You have several years of experience in Quality Management/ Pharma Assurance/Regulatory affairs.
  • You have knowledge of Good Distribution Practice, HACCP, ISO.
  • You have an excellent command of the English language.
  • You preferably have experience with Change & Deviation Management and with GAMP-5 validation.
  • You have a hands-on mentality and an independent working-style.

About us

SHOP APOTHEKE EUROPE is an international e-commerce company with headquarters in the Netherlands, offices in Cologne & Berlin and further locations in Europe. As one of Europe's leading e-pharmacies with web shops in seven countries, we ensure that millions of people can rely on us for their health every day. We are growing extremely dynamically and are looking for more team players who want to continue this exciting development and the successful growth of the past years together with us!


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