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Quality Assurance Specialist

35 minuti fa

Saluggia, Italia Novartis A tempo pieno

**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

Full time

Employment Type

Regolare

Shift Work

No