Quality Assurance Specialist
vor 3 Wochen
Job Summary
We are seeking a highly skilled Senior Auditor Quality Systems to join our Quality team. The ideal candidate will have a strong background in GxP quality systems, auditing, and supplier management.
Main Responsibilities
- Execute GxP quality systems audits of approved and potential suppliers of raw materials, components, and service providers.
- Prepare audit reports and assign levels of compliance based on established criteria.
- Deliver audit results to suppliers and evaluate supplier corrective action plans.
- Interpret and apply company policies, procedures, and regulations.
- Manage supplier quality agreements, including writing, editing, and reviewing.
Requirements
- Four-year degree in a relevant business or science field.
- Minimum of 3 years' experience in a GxP environment in the pharmaceutical industry.
- Strong understanding of FDA, PiC/S, and European regulations.
- Industry and auditing knowledge, with relevant experience.
- Fluent in English, with proficiency in other languages an asset.
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