Ph3Summary /h3 pThe QA Officer guarantees the quality oversight over the entire working time of the facility for all the ongoing GMP activities. /p h3About The Role /h3 h3Major Accountabilities /h3 ul liContribute to assuring the validation/qualification status of the production site, equipment, training of personnel and management of quality documentation. /li liResponsible for the provisional release for the shipment of batches. /li liWork in shift with other QA officers to oversight the production and quality control activities. /li liArchiving and support in managing the site GMP documentation. /li liReview of batch records and assure the timely closure of the manufactured batches. /li liContribute to maintaining the local quality system as per GMPs and corporate guidelines and in assuring the respect of the GMPs and Health Authorities requirements at local level. /li liSupport the QP in the preparation of batches release documents. /li liInvolvement in investigation of deviation, OOS, complaints, CAPA, change control implementation and redaction. /li liCollaborate and support during the external audits by the authorities and corporate audits. /li liContribute to redaction and review of SOPs, records, protocols and reports according to GMPs, National/ Corporate Guidelines and health authorities’ requirements. /li /ul h3Essential Requirements /h3 ul liScientific degree. /li liPrevious experience in a similar role within a sterile production environment. /li liGood knowledge of GMP. /li liAvailable to work in shifts, including night shifts and weekends (on a regular basis) /li liFluent in Italian. Good knowledge of English. /li /ul 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 pRead our handbook (PDF 30 MB) /p /p #J-18808-Ljbffr