Senior Compliance Specialist – GMP / Quality Assurance (Part-Time 25%) | Senior Compliance Specialist (m/w/d) – GMP / Qualitätssicherung in Teilzeit 25%

Job Summary

This role involves ensuring pharmaceutical production facilities operate in strict compliance with current Good Manufacturing Practices (cGMP), focusing on building design, cleanroom standards, and clothing requirements. The Senior Compliance Specialist will interpret and implement regulatory requirements, including the EU-GMP Guide and FDA Guidelines, to continuously improve cGMP conformity. Key responsibilities include preparing for and presenting during customer and regulatory audits, addressing observations, and implementing Corrective and Preventive Actions (CAPAs). The specialist will also advise teams on facility lifecycle models, room modifications, and clothing specifications, while acting as the primary contact for GMP-compliant documentation regarding changes, events, and deviations. This position requires a strong background in the pharmaceutical industry, expertise in European and US cGMP regulations, and excellent communication and organizational skills, offering a unique part-time opportunity within a reputable pharmaceutical company in Biberach.