Senior Auditor External Supplier Quality

vor 3 Wochen

St Gallen, Sankt Gallen, Schweiz CSL Vollzeit

About the Role

We are seeking a Senior Auditor External Supplier Quality to join our Quality team in St. Gallen, Switzerland. As a key member of our team, you will be responsible for executing GxP quality systems audits of approved and potential suppliers of raw materials, components, and service providers for our CSL Sites.

Main Accountabilities

  • Execute remote/desk audit process for GxP quality systems audits of approved and potential suppliers.
  • Prepare audit report and assign levels of compliance to each observed action based on established criteria.
  • Deliver audit results to suppliers, according to internal CSL timelines.
  • Evaluate supplier corrective action plans to ensure plans satisfactorily address the observation(s) and ensure the corresponding follow-up.

Key Tasks

  • Local Point of Contact for External Supplier Quality (ESQ) organization.
  • Plan, execute, and follow-up assigned audits.
  • Revise, edit, and route for signature Quality Agreements as assigned.
  • Supplier-related complaints follow-up (tracking, investigation completion, and proper CAPA plan).

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.
  • 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. We are a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology, and rare conditions. We strive to help patients around the world with severe, chronic, and rare diseases lead better, healthier lives.

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