Pharma Quality & Regulatory Specialist

BE AN ESSENTIAL PART OF EVERYDAY LIFE

Are you the type of person who takes initiative to solve problems?  Are you proactive and flexible to face changes and new challenges in a fast environment?  Are you curious and desirous to learn and to see the impact of your skills?

If so, DHL Supply Chain has the opportunity for you.

Pharma Quality & Regulatory Specialist – Life Sciences & Healthcare (Rome)

We are looking for a Pharma Quality & Regulatory Specialist to join Life Sciences & Healthcare operations in Rome. The role will support all quality assurance activities, including the implementation of quality policies and procedures, auditing tasks, and continuous improvement initiatives. The position will also contribute to regulatory activities, ensuring proper documentation management, compliance with local and international laws, and the execution of control processes to guarantee adherence to quality and regulatory standards.

You will contribute to maintaining the highest quality and compliance standards within our pharmaceutical warehouse environment.

Key Responsibilities

• Support the preparation, implementation, and maintenance of Quality Assurance policies and procedures;
• Assist in conducting internal and external auditing activities;
• Keep the archive of quality documentation and updating relevant reports/KPIs;                                                                                                                                                                                                       
• Ensure adherence to GxP standards and quality requirements;
• Help to ensure the laws and the regulations for the storage and distribution of human, narcotics  and veterinary medicines (DPR 309/1990, Legislative Decree 219/2006, Legislative Decree 193/2006) are adhered to;
• Support managing pharmaceuticals in compliance with existing SOPs;
• Assist in monitoring temperatures, analyzing trends and deviations trends in the various environments and the out-of-range, to ensure compliance towards the final customers, with analysis of the paths to verify their completeness and compliance;
• Collaborate on narcotics management: purchase orders, periodic reporting, import/export permits, and documentation;
• Contribute to root cause analysis and define corrective and preventive actions (CAPA) using DHL’s tool;
• Develop the projects in the Pharma BU for the sites involved;   
• Support for the management of training and annual training programs in the Quality/GDP, GMP area.                                                                                                                                                                                                                                                  

• Degree in Pharmacy, Chemistry, Pharmaceutical Chemistry and Technology (CTF), or related fields (a master’s/certification in QA is a plus)
• Good understanding of relevant regulatory requirements, quality assurance tools, and methodologies
• A good working proficiency in English is required
• Proficiency in Microsoft Excel and PowerPoint
• Previous experience in pharmaceutical sector and/or supply chain operations is preferred