Quality Assurance
CurrentProviding QA resource across multiple sites for the construction, support and embedding of the Pharmaceutical Quality System underwriting the Manufacturing, Analytical, Device Design Development, Vendor Management & other aligned areas. To ensure that the Pharmaceutical Quality System is built and embedded into the organisation and is efficiently executed. To provide QA support as directed by the QA Director, to colleagues in partner lines in the building of the Pharmaceutical Quality System with particular focus on the drug product clinical supply manufacturing, assembly, testing and release operations.Areas of particular focus are management of GxP documentation and management of the training processes.To assist in the creation of SOPs, Databases & Processes.Plan/Collaborate/Train/Rollout/Support all aspects of Documentum.Plan/Collaborate/Train/Rollout/Support Global Learning Management System.To manage the development and ongoing use of the GxP documentation system, including On Site Secure Storage and Off Site Archiving.