GMP Compliance Specialist Production | GMP Compliance Produktion (m/w/d)

Job Summary

This role involves ensuring strict adherence to Good Manufacturing Practice (GMP) standards within the pharmaceutical production environment, focusing heavily on visual inspection and Container Closure Integrity Testing (CCIT) for parenteral products. Day-to-day responsibilities include drafting and revising Standard Operating Procedures (SOPs), managing deviations, changes (CCs), and Corrective and Preventive Actions (CAPAs) related to quality control processes. The specialist will also conduct root cause analyses to identify particle contamination sources in injectables, classify particles, and implement process optimizations. Key qualifications include a university degree in Chemistry, Biotechnology, or related engineering fields, or at least five years of relevant professional experience, coupled with deep knowledge of current EU and FDA GMP regulations. This position is attractive for professionals seeking to apply their expertise in a research-intensive, innovative pharmaceutical company specializing in niche, high-responsibility products, offering a structured environment and opportunities for professional development.