Quality Assurance Lead for Analytics

Vor 5 Tagen

Visp, Schweiz Lonza Vollzeit

About the Role:

The Quality Assurance Analytics Team at Lonza is seeking a dedicated Senior Quality Assurance Specialist to join our fast-growing and innovative environment. As a key member of our team, you will be responsible for ensuring Quality oversight on GMP-relevant activities carried out by the Quality Control and Analytical Development departments.

Key Responsibilities:

  • Representing QA concerns to the Quality Control department and ensuring compliance with cGMP requirements and SOPs.
  • Control and release of GMP relevant documents, including SOPs, analytical test methods, method transfer protocols/reports, and method validation protocols/reports.
  • QA supervision for OOXs events during investigation in QC/AD, including review and approval of Out-of-Specifications/-Expectations/-Trend results.
  • Writing or revising SOPs in the area of expertise and ownership of these documents.
  • Ensuring compliance with cGMP in the areas of stability testing and reference standards.
  • Cooperation, review, and approval of deviations (DRs), Investigations (INV), changes (CRs), and CAPAs within analytics (QC).
  • Participating in customer Audits and Inspections.

Key Requirements:

  • Bachelor's or master's degree in chemistry, biotechnology, life science, or related field.
  • Significant experience in the pharmaceutical industry; preferably in a QC or QA function.
  • Founded analytical expertise and experience with analytical method validation.
  • Strong background in cGMP regulations; incl. USP, European and Japanese Pharmacopoeia.
  • Auditing experience and experience in the interaction with health authorities (FDA, Swissmedic, etc.).
  • Excellent verbal and written communication in English. German language knowledge is advantageous.

About Lonza:

Lonza is a global leader in life sciences operating across three continents. We are committed to improving lives all around the world through our products and services. Our people are our greatest asset, and we offer a dynamic and challenging work environment that encourages creativity, innovation, and collaboration.

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