This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
Perform laboratory activities inherent to the areas of Manufacturing and/or QC Immuno Liaison (pilot lot/batch preparation, immunometric testing, and performance evaluation), in compliance with Quality Procedures and applying GMP, interacting with other laboratories/units in an environment where equipment and spaces can be shared. Collaborate in defining industrialization processes and give a support in guaranteeing the industrialization deliverables, mainly for: new products and/or processes; design change of current products; change of products/processes, raw materials already industrialized into Operations’ area without impact on immunometric performance perceived by the user or declared; technology transfer process from another Site to DSI or from DSI to another DiaSorin Production Site; innovation and new continuous improvement ideas; validation activities of equipments/processes.
Job Responsibility:
Ensure compliance with the Code of Ethics, the Quality Management System, the Company Policies and the Corporate Procedures
Performs preparation of validation batches and/or pilots, in compliance with Quality Procedures and applying GMP
Performs immunometric QC testing, data tabulation, evaluation of results in order to assess immunometric performance, in compliance with Quality Procedures and applying GMP
Supports in drafting industrialization documents
Collaborates and supports the project team regarding the activities and deliverables of transfer, according to the Inter-Site procedures, including the support for production and QC flow training, and any validation activities (in the case of Sending Units)
Gives support for the implementation of product/process and performs the validation activities from production to release, in case DSI is the Receiving Site
Supports in data collection and validation planning
May deal with change management
Handles the preparation of any validation/pilot batches and/or their QC approval
Supports in change implementation and ensuring deliverables
Supports the team in data collection and analysis
Supports the team in the submission and approval of a new idea
Supports the team in the implementation of approved new ideas
Requirements:
Higher diploma or university degree in technical-scientific field
Experience in the role, gained in companies/laboratories in the biomedical sector, preferably in the Medical Device sector, or in hospital laboratories, is appreciated
Chemical, biology, biotechnology and immunometric assay knowledge