Manager GMP Compliance and Operational Excellence (OPEX) | Manager GMP Compliance/OPEX (m/w/i)

Job Summary

This critical role involves ensuring regulatory adherence and driving continuous process improvement within the production and technology sector, focusing on pharmaceuticals, dietary supplements, and medical devices in Iserlohn. The Manager will be instrumental in developing, maintaining, and optimizing concepts for workflows using methodologies like OEE, OpEx, 5S, and KVP. Core daily tasks include controlling material flows, creating and reviewing standard operating procedures (SOPs) and manufacturing instructions, and training affected employees. A major responsibility is overseeing strict GMP compliance, which involves conducting risk analyses, initiating and implementing Change Control measures, and managing Corrective and Preventive Actions (CAPA). The ideal candidate possesses a degree in Pharmacy, Pharmaceutical Technology, or a comparable technical/scientific field, and ideally brings initial professional experience from the pharmaceutical manufacturing environment. Success in this position requires a high degree of reliability, self-reliance, commitment, and pronounced hygiene awareness.