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Senior Quality Assurance Specialist

vor 2 Monaten


Visp, Schweiz Lonza Vollzeit

Job Summary:

The Material Management team at Lonza supports projects with strategic decisions and ensures that materials are purchased and released according to requirements.

About the Role:

We are seeking an experienced Quality Assurance (QA) Specialist to be responsible for raw materials, specifically during the entire manufacturing process of a pharmaceutical product, as part of an interdisciplinary team.

Key Responsibilities:

  • Ensure and maintain quality requirements for raw materials in a Good Manufacturing Practice (GMP) environment.
  • Responsible QA representative for raw material-specific aspects throughout the entire manufacturing process of a pharmaceutical product.
  • Responsible for reviewing and approving raw material-specific documents, including Quality Control plans, sampling instructions, and material lists.
  • Handle and support Out-of-Specification (OOS) investigations, deviations, Corrective Action and Preventive Action (CAPA) processes, and change control processes.
  • Support in supplier qualification activities.
  • Subject matter expert during regulatory inspections and audits.

Requirements:

  • Bachelor's degree in Chemistry, Biology, Biochemistry, Biotechnology, or a comparable qualification.
  • Experience in the GMP environment and the manufacture of drug products is an advantage.
  • High communication skills combined with assertiveness.
  • Fluent German and English skills.

About Lonza:

Lonza is a global leader in life sciences operating across three continents. We are committed to improving lives all around the world by developing innovative solutions in life sciences. Our people are our greatest asset, and we offer a dynamic and challenging work environment that allows them to grow and develop their careers.