Das ist der Job
Ihre 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 escape 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 Ihr Profil 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.
Darum lohnt es sich
Basic knowledge of another European language is a strong asset #J-18808-Ljbffr
