Senior Specialist, Final Release | Senior Specialist Final Release | M/W/D - Referenz 001044

Job Summary

This Senior Specialist role supports the Qualified Person (QP) within an internationally successful pharmaceutical company, focusing on the procedural and administrative aspects of final release for investigational medicinal products (IMPs). The core daily tasks involve rigorous review of release documentation to ensure complete compliance with regulatory submissions (CTAA), current Good Manufacturing Practice (cGMP), and internal quality guidelines, thereby enabling the QP's certification. The specialist is also responsible for conducting Batch Record Reviews, managing batch status assignment, and maintaining related data documentation. Furthermore, the role requires contributing to the continuous improvement and optimization of release processes and utilized systems. Candidates must possess a Master's degree in a scientific discipline or equivalent vocational training with extensive experience, coupled with deep expertise in national and international regulatory requirements for IMPs and cGMP. Excellent communication skills are essential for effective collaboration across internal and external interfaces. This position is initially temporary until October 31, 2026, and offers a hybrid work model.