Ph3Overview /h3 pbSummary /b Independently supervise, without any interference of third persons, manufacturing processes and control testing of the site, related to the drug manufacturing license, operating as Qualified Person according to the local law (Article 52 of the Legislative Decree n. 219 of April 24th 2006 from EU directive 2001/83/CE and following modifications). With respect to the quality of the medicinal products, assurance of compliance to the National Medicines Law and other applicable regulations and together with the Site Quality Head and Site Manager maintaining an effective implementation, monitoring and maintenance of a GMP-compliant quality system. /p pAs Quality Assurance, it is required to support all GMP relevant tasks/issues (operational and strategic) by ensuring compliance according to the ADACAP internal quality standards, relevant regulatory requirements, filed product quality standards and SOPs in place. /p h3Major accountabilities /h3 ul liGuarantee and certify that each batch of medicines is produced and checked in compliance with the law and the conditions imposed in the marketing authorization. /li liAssessment and release of manufactured medicinal products, in accordance with national legislation. /li liGuarantee that the documentation attesting the suitability of each product lot is available and can be shown at the request of the health authority. /li liCollaborate in the approval of deviation investigations. /li liMake sure that the batch record of the released batch is stored correctly and can be exhibited at the request of the health authority. /li liCommunicate immediately to the national Health Authority (AIFA) and to the Management any substantial irregularity detected in the product that has already been placed on the market. /li liWork in collaboration with Quality Control and Production departments in the activities related to the manufactured batches. /li liIdentify and propose technological and organizational interventions aimed at improving manufacturing processes in terms of quality, productivity and costs and the optimization of resources. /li liCollaborate with the Function Managers in order to guarantee the correctness of the Quality Management System. /li liManagement of deviations, complaints, change control and CAPA. /li /ul h3Essential Requirements /h3 ul liDegree in Pharmacy, CTF or Chemistry. /li liPrevious experience in the role within a pharmaceutical sterile manufacturing environment (Authorized Qualified Person certificate according to Legislative Decree n. 219 of April 24th, 2006). /li liStrong affinity with quality and awareness of quality issues. /li liOpen and clear collaboration and communication to make sure the daily production operation runs smoothly and safely. /li liFluent in Italian and English. /li /ul pThis role is 100% site based in Ivrea. /p h3Why Novartis /h3 pHelping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? /p h3Benefits and Rewards /h3 pLearn about all the ways we’ll help you thrive personally and professionally. /p /p #J-18808-Ljbffr