Senior Compliance Specialist (Part-Time 25%) | Senior Compliance Specialist in Teilzeit 25% (m/w/d)

Job Summary

This role seeks an engaged Senior Compliance Specialist to ensure CGMP-compliant operations within a renowned pharmaceutical company, focusing specifically on facility design, cleanroom standards, and clothing requirements for pharmaceutical production buildings. Day-to-day responsibilities include interpreting and implementing regulatory requirements, such as EU-GMP guidelines and FDA regulations, to continuously improve CGMP compliance in operational processes. The specialist will prepare for and present during customer and regulatory audits/inspections, process observations, and implement derived Corrective and Preventive Actions (CAPAs). Furthermore, the role involves advising site teams on the lifecycle model for implementing, expanding, and modifying facilities and clothing specifications, managing GMP-compliant documentation for deviations, and continuously developing the existing quality system for efficiency and quality improvements. Key requirements include a relevant scientific Master's degree or equivalent experience, extensive knowledge of European and US CGMP regulations, and strong communication skills.