Qa officer - temporary

Ph3Summary /h3 pManage Quality aspects and projects within area of responsibility. Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems. /p h3About The Role /h3 pIn this role you will be required to work in shifts, including night turns and weekends on a regular basis. /p 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. /li liFluent in Italian. Good knowledge of English. /li /ul h3Benefits and Rewards /h3 pRead our handbook to learn about all the ways we’ll help you thrive personally and professionally: /p h3Diversity and Inclusion /h3 pNovartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. /p /p #J-18808-Ljbffr