Qa officer - temporary

Ph3Band Level 3 Job Description Summary /h3pManage Quality aspects and projects within area of responsibility. Ensures and supports overall GxP conformity and compliance with the Novartis Quality Management Systems. /ph3Job Description /h3pIn this role you will be required to work in shifts, including night turns and weekends on a regular basis. /ph3Major Accountabilities /h3ulliContribute to assuring the validation/qualification status of the production site, equipment, training of personnel and management of quality documentation. /liliResponsible for the provisional release for the shipment of batches. /liliWork in shift with other QA officers to oversight the production and quality control activities. /liliArchiving and support in managing the site GMP documentation. /liliReview of batch records and assure the timely closure of the manufactured batches. /liliContribute 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. /liliSupport the QP in the preparation of batches release documents. /liliInvolvement in investigation of deviation, OOS, complaints, CAPA, change control implementation and redaction. /liliCollaborate and support during the external audits by the authorities and corporate audits. /liliContribute to redaction and review of SOPs, records, protocols and reports according to GMPs, National/ Corporate Guidelines and health authorities’ requirements. /li /ulh3Essential requirements /h3ulliScientific degree. /liliPrevious experience in a similar role within a sterile production environment. /liliGood knowledge of GMP. /liliAvailable to work in shifts, including night shifts and weekends. /liliFluent in Italian. /liliGood knowledge of English. /li /ulh3Skills Desired /h3ulliCollaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Decision Making, Digital saviness, Leadership, Problem Solving Skills, Regulatory Requirements knowledge. /li /ul /p #J-18808-Ljbffr