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 pharmaceutical or biotech environment.
• Available to work in shifts, including night shifts and weekends (on a regular basis)
• Fluent in Italian. Good knowledge of English.