Quality Assurance Specialist

vor 2 Wochen


St Gallen, Sankt Gallen, Schweiz CSL Vollzeit

Job Summary

We are seeking a Quality Assurance Specialist to join our Quality team in St. Gallen, Switzerland. The ideal candidate will support the local site regarding supplier/third-party qualification status and process, reporting directly to the Head of Supplier Quality Management (CH).

Main Responsibilities

  1. Execute GxP quality systems audits of approved and potential suppliers of raw materials, components, suppliers, and service providers for the CSL Sites.
  2. Prepare audit reports and assign levels of compliance to each observed action based on established criteria.
  3. Deliver audit results to suppliers, according to internal CSL timelines.
  4. Evaluate supplier corrective action plans to ensure plans satisfactorily address the observation(s) and ensure the corresponding follow-up.

Key Requirements

  • Requires a four-year degree in a relevant business or science, or equivalent education and experience.
  • Minimum of 3 years' experience in a GxP environment in the pharmaceutical industry.
  • Thorough understanding of required regulations including FDA, PiC/S, and European regulation, Therapeutics Goods Authority, Canadian Health Authority, etc.
  • Industry and auditing knowledge (internal and external), with relevant evidence.

About CSL Vifor

CSL Vifor aims to become the global leader in iron deficiency and nephrology. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology, and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic, and rare diseases lead better, healthier lives.


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