Summary
Manage Quality aspects and projects within area of responsibility. Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.
About The Role
In this role you will be required to work in shifts, including night turns and weekends on a regular basis.
Major Accountabilities
- Contribute to assuring the validation/qualification status of the production site, equipment, training of personnel and management of quality documentation.
- Responsible for the provisional release for the shipment of batches.
- Work in shift with other QA officers to oversight the production and quality control activities.
- Archiving and support in managing the site GMP documentation.
- Review of batch records and assure the timely closure of the manufactured batches.
- Contribute 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.
- Support the QP in the preparation of batches release documents.
- Involvement in investigation of deviation, OOS, complaints, CAPA, change control implementation and redaction.
- Collaborate and support during the external audits by the authorities and corporate audits.
- Contribute to redaction and review of SOPs, records, protocols and reports according to GMPs, National/ Corporate Guidelines and health authorities’ requirements.
Essential Requirements
- Scientific degree.
- Previous experience in a similar role within a sterile production environment.
- Good knowledge of GMP.
- Available to work in shifts, including night shifts and weekends.
- Fluent in Italian. Good knowledge of English.
Benefits and Rewards
Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Diversity and Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
