Senior Auditor External Supplier Quality

vor 4 Wochen

St Gallen, Sankt Gallen, Schweiz CSL Vollzeit

Job Summary

We are seeking a highly skilled Senior Auditor External Supplier Quality to join our Quality team in St. Gallen. The successful candidate will support the local site regarding supplier/third-party qualification status and process, and will report directly to the Head of Supplier Quality Management (CH).

Main Responsibilities

  • Execute GxP quality systems audits of approved and potential suppliers of raw materials, components, suppliers, and service providers for the CSL Sites.
  • Prepare audit reports and assign levels of compliance to each observed action based on established criteria.
  • Evaluate supplier corrective action plans to ensure plans satisfactorily address the observation(s) and ensure the corresponding follow-up.
  • Responsible for interpreting and making decisions based on company policies and procedures, regulatory agencies, local, state, federal, and international regulations.
  • Responsible for supplier quality agreements, global and local, which include writing, editing, reviewing, updating, and routing the agreements for approvals between CSL Sites, service providers, and suppliers.

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.
  • Must be comfortable working in a global, matrix organization.
  • Fluent in English (written and spoken). Other languages (German, French) would be an asset.

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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