Quality Assurance Specialist – GMP & Compliance

IT58 (FCRS = IT058) Advanced Accelerator Applications Italy Srl; Saluggia; Hybrid; EUR 30,000 - 55,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Hybrid work options

Parental leave

Job summary

Novartis AG in Saluggia, Italy, is seeking a Quality Assurance Expert to safeguard GMP standards across manufacturing. You will collaborate with cross‑functional teams to strengthen processes, support audits, and drive continuous improvement at the Saluggia site.

The role requires a university degree in a scientific discipline, at least 1 year in a quality department, and fluent English. A hybrid working setup is available, with emphasis on inspection readiness and regulatory compliance.

Qualifications

• University degree in a scientific discipline.
• At least 1 year in a Quality department, preferably in a regulated environment.
• Good knowledge of GMP and Quality Management System principles.
• Fluency in English, both written and spoken.

Responsibilities

• Ensure manufacturing activities comply with Good Manufacturing Practice, regulatory requirements, quality standards, and approved procedures.
• Review and approve batch records, specifications, control methods, protocols, and Quality Management System documentation.
• Manage deviations, corrective and preventive actions, and change controls, ensuring robust investigation and timely resolution.
• Review investigations involving out-of-specification, out-of-trend, out-of-expectation results, and system suitability test failures.
• Manage product complaints and support supplier qualification activities in line with established quality requirements.
• Prepare Annual Product Quality Reviews and contribute to the development and maintenance of the Site Master File.
• Support internal audits, self-inspections, and Health Authority inspections, ensuring strong inspection readiness.
• Partner with cross-functional teams to improve manufacturing processes, quality performance, productivity, and operational effectiveness.

Skills

Attention to detail

Organizational skills

Collaboration

English proficiency

Education

University degree in a scientific discipline

Job description

Novartis AG in Saluggia, Italy, is seeking a Quality Assurance Expert to safeguard GMP standards across manufacturing. You will collaborate with cross‑functional teams to strengthen processes, support audits, and drive continuous improvement at the Saluggia site.

The role requires a university degree in a scientific discipline, at least 1 year in a quality department, and fluent English. A hybrid working setup is available, with emphasis on inspection readiness and regulatory compliance.