As a specialist in deviation management, the employee accompanies the production of pharmaceutical active ingredients across all production phases – starting with the inoculum phase, through the upstream and downstream processes, to the final formulation. He is responsible for both internal products of the ep customer and projects from external contract manufacturing. As soon as a deviation is reported, he takes responsibility for its comprehensive processing: He coordinates interdisciplinary meetings, analyses causes together with the departments involved and develops effective solutions. Finally, he prepares GMP-compliant reports, checks them carefully and ensures their release.

His area of responsibility requires close and regular cooperation with numerous interfaces within the company – in particular with the Quality Unit and Manufacturing, but also with related departments such as laboratory, engineering or logistics. To ensure the highest quality and compliance standards, he also occasionally coordinates measures with external locations.

With his strong communication skills, analytical thinking and a deep understanding of regulatory requirements (FDA guidelines, EU GMP Guideline Annex 5), he makes a significant contribution to ensuring the company's high quality standards. With his structured approach, he ensures that all deviations are dealt with effectively and that the production of active pharmaceutical ingredients can continue safely.