ITS' Tutor's Experience

ITS' Tutor's Experience

ITS’ Regulatory Compliance Services’ Manager, Elizabeth Vaughan, has developed extensive knowledge of this specialist area from over 30 years’ industry experience working with Sanofi, Bristol Myers Squibb, Diomed Developments and Vifor Pharma UK.

Elizabeth has worked in quality roles within the laboratory and pharmaceutical industry, and gained extensive experience in global quality systems and regulatory affairs, as well as ISO 13485, ISO 9001 and cGMP compliance. Throughout her career, she has been responsible for sharing her knowledge through the design and delivery of a range of training courses for production personnel including Good Manufacturing Practice, Change Control, Deviation Management, Electronic Record Compliance, Validation and Management of API Suppliers/Manufacturers. Elizabeth also has extensive experience in providing quality and GMP training to improve the performance of site quality managers.

Elizabeth started her career as an Analyst with Fisons Pharmaceuticals, where her responsibilities included analytical testing of raw materials, intermediates, finished products using computerised instrumentation and training junior members of staff. Her career then progressed to Team Leader roles in product analytical testing including the management of stability studies, coordinating the day to day running of testing team activities, managing new equipment qualification processes, as well as coaching and developing team members.

Building on her previous knowledge, Elizabeth moved into Quality Assurance and has accumulated over 13 years’ experience in continuous quality management system maintenance and improvement to meet regulatory requirements and industry best practice. Her experience includes auditing quality standards in GMP operations, managing change control, deviation and investigation reporting, validation processes and training GMP requirements. Her final role before joining ITS’ team was Quality Manager at Vifor Pharma UK Ltd.

With an exceptional compliance background and understanding, Elizabeth has a great deal of experience in identifying and driving best practices relating to the control and appropriateness of quality systems, records and documents, as well as ensuring strict adherence to appropriate standards and regulatory requirements including ISO 9001 and ISO 13485.

Elizabeth has been responsible for developing and managing the implementation of harmonised global quality management systems, CAPA systems, as well as producing, monitoring and maintaining KPIs. Her roles have involved driving company quality strategies and continuous improvement initiatives.

With a passion for auditing and an IRCA Lead Auditor Training Certificate, Elizabeth’s duties have included hosting and managing audits with notified bodies including the MHRA, performing internal audits and auditing critical suppliers.



Contact our team today

For further information, please contact
our team on +44 (0)1642 222232 or
email enquiries@its-ltd.co.uk