Aufgaben

  • Spearhead the creation and execution of the annual external QA audit and internal self-inspection plans
  • Conduct thorough GMP/GDP audits and self-inspections in close coordination with internal departments and global suppliers
  • Promptly report and escalate critical audit findings to the Responsible Person (RP) and senior management
  • Create, negotiate, and maintain Quality Agreements (QAs) with external suppliers and vendors
  • Act as the primary bridge between Quality, Regulatory Affairs, Compliance, and Operations
  • Manage and oversee Change Controls, Deviations, and CAPAs (Corrective and Preventive Actions) related to audit findings
  • Support the site and the QA team in preparing for upcoming health authority and regulatory inspections

Qualifikationen

  • Minimum of 3–6 years of auditing experience within a strict GMP/GDP regulated environment, including at least 1 year acting as a Lead Auditor
  • Deep and excellent knowledge of international GMP/GDP guidelines, quality regulations, and industry best practices
  • Proven ability to manage complex quality projects independently and drive them to successful completion
  • High level of detail-orientation, strong analytical skills, and a diplomatic yet assertive communication style
  • Fluency in English (written and spoken) is mandatory. Basic knowledge of another European language is a strong asset