QA Officer

Novartis; Ivrea; In loco; EUR 30.000 - 45.000; Tempo pieno

Descrizione del lavoro

Une entreprise pharmaceutique de premier plan recherche un QA Officer pour garantir le respect des normes GMP au sein de son site de production en Italie. Le candidat idéal a une expérience dans un environnement stérile, est capable de travailler en équipes et doit être disponible pour des horaires variés incluant les nuits. Ce rôle est essentiel pour assurer la qualité et la conformité des produits avant leur expédition.

Competenze

• Expérience antérieure en tant que QA Officer dans une entreprise pharmaceutique ou biotech.
• Disponible pour travailler en horaires décalés, y compris les nuits et les week-ends.
• Fluent en italien et bonne connaissance de l'anglais.

Mansioni

• Garantir la qualité et l'oversight des activités GMP.
• Contribuer à la validation et qualification du site de production.
• Collaborer lors des audits externes par les autorités.

Conoscenze

Contrôle qualité

Collaboration

Gestion de documentation GMP

Investigation de déviations

Formazione

Expérience dans un environnement stérile

Descrizione del lavoro

The QA Officer guarantees the quality oversight over the entire working time of the facility for all the ongoing GMP activities.

• About the Role
• 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.
• 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.

Division

Operations

Business Unit

Location

Italy

Site

Company / Legal Entity

IT58 (FCRS = IT058) Advanced Accelerator Applications Italy Srl

Functional Area

Quality

Job Type

Full time

Employment Type

Temporary (Fixed Term)

Shift Work

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.