GMP Compliance Auditor | GMP Compliance Auditor (m/w/d)
Abax Personaldienstleistungen GmbH
Job Summary
This role is for a highly experienced GMP Compliance Auditor based in Ludwigshafen am Rhein, focusing on ensuring adherence to international regulatory standards for pharmaceutical products, medical devices, and regulated studies. The auditor will be responsible for independently planning and conducting internal system audits and external GxP supplier audits, maintaining the approved supplier list, and tracking audit metrics for trend analysis. Key requirements include a Bachelor's degree in Biosciences or Engineering, strong leadership skills, and at least five years of experience in quality assurance, regulatory affairs, or the pharmaceutical/medtech industry. The ideal candidate will also recommend action plans for resolving quality issues, provide GxP training and consultation, and support management during external regulatory inspections, operating with significant autonomy and minimal supervision.
Required Skills
Education
Bachelor's degree, preferably in Biosciences or Engineering; Equivalent combination of education and experience accepted; Professional organization accreditation desirable (e.g., ASQ Certified Quality Manager or Certified Quality Auditor)
Experience
- Minimum 5 years in Quality Assurance, Regulatory Affairs, or related fields (Pharma/MedTech/Healthcare industry)
- Experience with quality assurance audits (advantageous)
- Laboratory experience (advantageous)
- Demonstrated success utilizing core and professional competencies
Languages
Additional
- Located in Ludwigshafen am Rhein; Expected to lead objectives with cross-functional or broader scope; Must be capable of independent problem-solving with minimal oversight
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