GMP Compliance Auditor | GMP Compliance Auditor (m/w/d)
Personalhansa Dienstleistungsges. mbH
Job Summary
This role is for an independent GMP Compliance Auditor based in the Rhine-Neckar Metropolitan Region, focusing on ensuring adherence to international regulatory standards for pharmaceutical products and medical devices. The auditor will independently plan and execute internal system audits and external GxP supplier audits, maintain the approved supplier list, and manage the global audit schedule. Key responsibilities include interpreting and applying current GxP regulations, recommending action plans for compliance issues, and providing guidance and training on GxP guidelines to personnel. Candidates must possess a Bachelor's degree, preferably in life sciences or engineering, strong leadership skills, and a thorough understanding of international GMP standards, coupled with at least five years of relevant professional experience in Quality Assurance or the regulated healthcare industry.
Required Skills
Education
Bachelor’s degree preferably in life sciences or engineering; Equivalent combination of education and experience accepted; Accreditation by a professional body desirable (e.g., ASQ Certified Quality Manager or Certified Quality Auditor)
Experience
- 5+ years experience in Quality Assurance / Regulatory Affairs or related fields
- 5+ years experience in the Pharmaceutical / Device / Healthcare Industry
- Quality Assurance auditing experience (preferred)
- Laboratory experience (preferred)
- Proven track record utilizing core and technical competencies
Languages
Additional
- Located in the Rhine-Neckar Metropolitan Region; Permanent contract (Unbefristet); Must be able to carry out job duties independently and resolve project team issues with minimal oversight.
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