Lead Compliance Specialist (Part-Time 25%) | Leitender Compliance-Spezialist m/w/d TZ 25% (9,38h/Wo) 34,46€ plus Prämien

Job Summary

This part-time (9.38 hours/week) Lead Compliance Specialist role, based in Biberach an der Riß within the pharmaceutical industry, focuses on ensuring CGMP-compliant operation of pharmaceutical production facilities. The specialist will interpret and implement regulatory requirements, specifically EU-GMP guidelines and FDA regulations, to continuously improve CGMP compliance related to operational procedures, facility design, cleanroom standards, and clothing requirements. Key responsibilities include preparing for and presenting during customer and regulatory audits, managing observations, and implementing corrective and preventive actions (CAPAs). The role involves advising teams on the lifecycle model for facility implementation and changes, and maintaining GMP-compliant documentation for changes, events, and deviations. This position offers a hybrid work model, allowing for 2-3 days of remote work after the initial on-site training period, making it attractive for professionals seeking specialized part-time compliance work.