Senior Compliance Specialist (Part-Time) | Senior Compliance Specialist Teilzeit | M/W/D - Referenz 001026

Job Summary

This role is a crucial part-time (25%), temporary position (18 months) within an internationally successful pharmaceutical company, focusing on maintaining and improving CGMP compliance. The Senior Compliance Specialist will ensure pharmaceutical production facilities adhere to CGMP standards regarding building design, cleanroom design, and clothing requirements. Key responsibilities include interpreting and implementing regulatory requirements (like EU-GMP guidelines and FDA guidelines) to continuously enhance CGMP conformity in operational processes. The specialist will prepare for and present during customer and regulatory audits, handle resulting observations, and implement corrective and preventive actions (CAPAs). Candidates must possess a Master's degree or equivalent in a natural science field (e.g., Chemistry, Pharmacy) or a Master Craftsman qualification with professional experience, coupled with extensive knowledge of European and US CGMP regulations and experience in biopharmaceutical manufacturing. Strong communication, planning, and presentation skills are essential for success in this role.