Quality Documentation and Training Administration (QDTA) is an operational function within R&D Quality & Compliance, our team members are based in California USA and Cambridge UK. QDTA support our organisation’s enterprise wide compliance with Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPvP), Good Laboratory Practices (GLP) and associated regulations through provision of high quality support and service in administering and maintaining the Global Quality Management System (QMS). Key activities include the collection, quality control, approval routing, reporting, and management of critical documentation and data, and serving as a subject matter expert for the use of tools and systems that support these activities.
An exciting opportunity has arisen for a talented professional to join our team based in Cambridge UK.
• BS or BA degree with no experience or 2+ years of relevant experience in absence of formal qualification.
• Experience working in a regulated or GxP environment is desirable.
• Familiarity with/use of validated document management and learning management system software, and applications eg Documentum, Veeva Vault, UL Compliance Wire is desirable.
Quality Documentation and Training Administration