GMP Compliance Expert in QA

vor 1 Tag


Visp, Schweiz TN Switzerland Vollzeit

TN Switzerland is a global leader in life sciences with a strong commitment to innovation and collaboration. We are seeking a dedicated Senior Quality Assurance Specialist for Analytics to join our team.

In this role, you will work closely with our Quality Control and Analytical Development departments to ensure the quality of GMP-relevant activities. This includes reviewing and approving SOPs, analytical methods/specifications, and validation plans/reports to ensure compliance with our standards, customer requirements, and health authority expectations.

You will also be responsible for representing QA concerns and ensuring cGMP requirements are met. Key responsibilities include:

  • Representing QA concerns to the Quality Control department and ensuring cGMP requirements are followed.
  • Controlling and releasing GMP relevant documents of the QC department.
  • Reviewing and approving SOPs, analytical test methods, method transfer protocols/reports, and method validation protocols/reports issued by the QC/AD departments.
  • QA supervision for OOX events during investigation in QC/AD: Reviewing and approving 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.
  • Cooperating, reviewing, and approving deviations (DRs), investigations (INV), changes (CRs), and CAPAs within analytics (QC).
  • Participating in customer audits and inspections.


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