Change Specialist
CurrentPRIMARY TASKS• Perform business evaluation and scoping of change requests to existing products with impact on SKU/dossier within Specialty Rx and OTC• Communicating and collaborating with internal and external stakeholders in order to scope the change requests(CR) and in order to create timelines for execution• Responsible for ensuring that the change requests are assessed by relevant Subject Matter Experts (SME) and other stakeholders, in order to secure that change controls (CC) contain all relevant tasks and that changes are compliant with current legislation• Creating a proposed timeline for execution for change controls, in order to secure that release critical tasks are performed prior to ordering or release of products• Planning and coordinating cross functional change controls• Converting change requests (CR) to change controls (CC) – creating the CC and uploading the CC to Veeva in accordance with EU GMP/GDP• Responsibility with other Change Specialists towards the shared CR Office mailboxSECONDARY TASKS• Creation and maintenance of master data in Axapta (finished products, packaging, raw materials and bill of materials) • Authorization of master data in Axapta (finished products, packaging, raw materials and bill of materials) • Handling of unlock requests in Axapta • Execution of Change Control tasks • Training of colleagues and new employees• Maintenance in relation to the VNR database• Superuser Veeva CC module