About the company RAFARM is an innovation-driven, dynamically growing pharmaceutical company and a well-established European manufacturer with an outward-looking orientation that invests 13% of net turnover in Research and Development. We introduce high technology in our state-of-the-art sterile manufacturing plant and create new production lines with cutting-edge technology and robotic equipment. RAFARM is a place where our people evolve and are full of passion and interests. We are a dynamic team that empowers talent, embraces diversity and accelerates development. About the role Our Operation department is growing and we are seeking a detail-oriented professional with a strong understanding of serialization regulations, packaging technologies, and compliance standards to join the team as a Serialization Specialist. The role main accountabilities • Management of business partners and ensuring interfaces between systems is maintained and validated according to Rafarm policies and procedures • Championing CMO onboarding activities as it relates to serialization • Creating/Editing Level 1 Print files: Data Matrix Configuration, Human Readable Lines Configuration. Managing Level 2 and Level 3 software between batches to ensure smooth operations. Managing & maintaining Level 4 software to ensure uninterrupted supply chain operation • Coordinate all serialization activity and system interfaces with the appropriate team such as: IT, Production, Quality and Regulatory • Manage change controls and deviations associated with Serialization as well as issuing CAPAs as required • Manage Serialization Issue Log and be able to interpret EPCIS events according to the GS1 standards • Lead resolution of all issues associated with serialization and provide department SOPs • Audit trail and data review with the understanding of 21 CFR PART 11. • Development of Design Qualifications, Functional Requirements, User Requirements, Unit test scripts, UAT scripts, validation plans, validation summary report, traceability matrix, IQ/OQ/PQ • Contribute in the definition of the future technology roadmap by identifying value adding technology opportunities, and support the implementation of SAP S/4HANA