**Summary**:
The QA Specialist manages all aspects and projects within the Quality Assurance department.
They guarantee and support GxP conformities and Novartis Quality System. **About the Role**:
**Major accountabilities**: - Support technological and organizational interventions aimed at the improvement of manufacturing processes in terms of quality, productivity and costs and the optimization of the resources relating to the site.
- Ensure that the company manufacturing objectives and policies are consistent with GMPs.
- Support the development and implementation of projects related to new or existing products.
- Approve/verify the documentation (batch record, specifications, sampling and control methods, procedures of the Quality Management System, protocols).
- Ensure the update of the lists of documents related to the Quality Management System based on the indications of the reference SOPs.
- Draft Annual Product Quality Review and collaborate in drafting of Site Master File.
- Manage the product complaints, CAPAs and change controls.




- Review and approve the investigations in case of analytical results out of specification (OOS), out of trend (OOT), out of expectation (OOE) or System Suitability Test failures.
- Support the preparation and execution of internal audits and Health Authorities inspections and the execution of Self Inspections.
- Manage the Supplier Qualification. **Essential requirements**: - Scientific Degree.
- Previous experience within the Quality Assurance department of a pharmaceutical/biotech company.
- Clear and effective communication skills.
- Fluent in Italian and English.
- Willing to relocate to Saluggia with the flexibility of working from home 1x/week. Division Operations Business Unit Innovative Medicines Location Italy Site Saluggia Company / Legal Entity IT58 (FCRS = IT058) Advanced Accelerator Applications Italy Srl Functional Area Quality Job Type Tempo pieno Employment Type Regolare Shift Work No

📌 Quality Assurance Specialist (Saluggia)
🏢 Novartis
📍 Saluggia