Lucia Dalvit

  • Since I was a child, I had a passion for the human body and its physiology. This is one of the reason why I loved my university master that taught me the biochemistry behind the anatomy and physiology and the drug interactions inside of us which I am still finding this fascinating.

    Currently I love being part of projects and I find a great satisfaction when the projects are completed successfully. It a privilege to work everyday to support patients getting the medicines they need.

    I love sharing my experience and knowledge with other people and at the same time I truly believe that there is always something to learn from each new adventure.

  • My career begun in a Radiopharmacy in a hospital as radiopharmacist preparing and testing the radioligands used to detect different illnesses. As my career developed I became more and more evolved in GMP and Pharmaceutical manufacturing.

    The next roles have been as QP in different companies that were importing different types of products (commercial and IMPs, ATMPs) from around the world. As part of this work I have implementing multiple quality systems to support such manufacturing and import activities, commonly without observations, I run these systems successfully.

    Through my carrier I have worked in the packaging area of commercial and IMPs products as a QP and Quality expert. I enjoyed particularly enjoy packaging QP role as people commonly underestimate the primary and secondary packaging challenges and the implications of it.

    In the recent years I support different companies as QP/QA contractor conducting audits, training, implementing process and acting as QP mainly in the importing area and packaging area.

    • Implementation of new processes: I have a proven ability to implement processes especially for the importation of IMPs into the UK.

    • QP activities: I am able to provide QP Certification on different dosage forms especially for products imported from third countries. As part of the role, I am also an accredited IRCA auditor who can support required audits.

    • GMP Training & Presentations: I am able to provide tailored training sessions and presentation based on the client requirement/ expectations.

    • Mentoring & Developing People: this is one of my greatest passions to see people teams grasp and embrace technical concepts and find solutions! Passing on knowledge is a real privilege!

    • Implementing complete pharmaceutical quality system and process for the importation of IMPs from third countries and EU, packaging of IMPs. Without competent authority observations.

    • Conducting tailored GMP training for a company that was tired of the general training presentations.

    • Product on boarding and QP release of IMPs, ATMPs, Commercial OSD, Sterile manufacture.

    • Various technical deviation and validation troubleshooting and resolution implementation.

  • English, Italian

 AFFILIATIONS

CLIENT FEEDBACK

  • “Lucia is a privilege to work with an exceptionally diligent and pragmatic QP, she enabled us to obtain our MIA, building it from scratch to meet our custom and quite nesh needs. Moreover, the inspector when granting us our licence said that in the last 10 years this is the first time, she has given no observation and not even a comment!”

    — Managing director SME pharma company

  • “Lucia’s passion for patient first, is evident in all she does. Her technical acumen and attention to detail makes her an asset! What is more important is that she educates and explains always making the time.”

    — Head of Quality and QP

  • “TDP has helped me build out my QMS to enable UK WDA registration with only comments from the Inspectorate. They always met the agreed timelines allowing for easy project management.”

    — Head of Quality and QP

  • “TDP is a privilege to work with. Thomas and the Team work efficiently with extreme diligence and care. Providing prompt batch review records that allow easy and expedient batch release of ATMP IMPs.”

    — Head of Quality and QP

  • “As the CEO of a large pharmaceutical company having access to TDP and the team means I have had access to precise and detailed advise well researched and reliable. It has enabled us to solve importation, supply chain problems and quality issues. The speed and variety and professionalism of service is impressive for such a young company, led by such a young MD. Privilege to work with. Looking forward to a long and strong partnership as a member of my senior advisory team!”

    — CEO large pharmaceutical company

  • “Thomas’s is an auditor of a type and Quality the like I have rarely encountered. The depth and detail of his work is phenomenal, not only that he took the time after the audit was said and done to give us a brief set of option appraisals to answer mine and my teams' questions in full and with pragmatism.”

    — Head of Quality, Multinational Pharmaceutical Manufacture Company

  • “Thomas has a broad knowledge of all GXPs/Quality regulations on a global level. Thomas has an excellent eye for detail whilst executing audits and has overall high understanding of all topics which need to be covered during an audit. I have personally audited with Thomas which involved high profile contractor audits known for critical Findings and recalls. Thomas identified multiple major/critical Findings. Thomas is a skilled auditor, and he is also in the process of training as a QP. Amazing Contract Auditor.”

    — Head of Audit, Multinational Pharmaceutical company

  • “Thomas was a colleague of mine whilst I was acting as a Qualified Person. He displayed a comprehensive knowledge of applicable legislation and industry GxP expectations. His meticulous planning was of great benefit during GMP audits and together with his flair for technology and software made him a pivotal team member.”

    — QP and Ex Inspector

  • “Nick is known for his ability to see and smell out poor practice, but unlike many auditors/consultants he doesn’t just report it. He will explain the issues and problems consequences to me as the client but more importantly to the individual at the time. He is always willing to go the extra mile.”

    — Senior Director of Quality, Multinational pharmaceutical company