(Senior) GMP Compliance Specialist | Pharmazeut (m/w/d)

Job Summary

This role is centered around ensuring strict GMP compliance within a leading biopharmaceutical company specializing in immunological treatments. The specialist will be responsible for conducting the technical review (Batch-Record-Review) of manufacturing documentation and maintaining production-relevant data within the Statistica database. Key responsibilities include optimizing and maintaining existing Standard Operating Procedures (SOPs) and manufacturing documents, creating new documentation aligned with current GMP requirements, and managing training documentation. A critical component of the job involves processing deviations and Corrective and Preventive Actions (CAPA) for the Production department, including internal coordination and follow-up. The ideal candidate holds a degree in Biotechnology, Pharmacy, or Biochemistry, possesses at least three years of professional experience in pharmaceutical manufacturing and GMP documentation, and has comprehensive knowledge of quality systems, including Change Control Management. Experience with statistical data analysis is beneficial.