Quality Assurance Specialist
vor 2 Wochen
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
- 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.
- 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 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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