Senior QA Specialist Analytics

vor 2 Wochen

Visp, Schweiz Lonza Vollzeit

Role Overview

The QA Analytics Team at Lonza is seeking a dedicated Senior QA Specialist to join their fast-growing and innovative environment. As a key member of the 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 cGMP requirements and SOPs are followed.
  • Control and release of GMP relevant documents, including SOPs, analytical test methods, method transfer protocols/reports, and method validation protocols/reports.
  • QA supervision for OOX events during investigation in QC/AD: Review and approve Out-of-Specifications/-Expectations/-Trend results.
  • Write or revise 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.

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.

At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. We offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

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