N

Novartis

Global pharmaceutical company delivering science-based innovations

Quality Assurance Expert

Regulatory & Quality (Life Sciences)Posted on Nov 10
Full-timeSaluggia, Italy

About the Job

Requirements

  • A university degree in a scientific discipline.
  • At least 1 year of experience in a Quality department, preferably within a regulated environment.
  • Good knowledge of Good Manufacturing Practice and Quality Management System principles.
  • Basic knowledge of relevant regulatory requirements and their application within quality operations.
  • Fluency in English, both written and spoken.
  • Strong organizational skills, attention to detail, a collaborative mindset, and the ability to prioritize tasks with appropriate urgency.

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, and 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.

About the Company

Novartis

Global pharmaceutical company delivering science-based innovations

Novartis is a global pharmaceutical company that uses science-based innovations to develop treatments and improve patient outcomes worldwide. Its products are medicines developed through research and development to address various diseases, aiming to reach nearly 1 billion people. The company differentiates itself by large-scale investment in R&D, a global presence with a diverse workforce, and a clear mission to Reimagine Medicine, focusing on meeting the changing needs of patients. Its goal is to improve quality of life and extend life expectancy by delivering meaningful therapies through its research and development efforts.

Company size
10,001+
Company stage
IPO
Headquarters
Basel, Switzerland
Founded
1970

Recently Posted Jobs

Explore more opportunities at Novartis

See more jobs