Quality Expert for the Regional QA GMP/GDP EUCAN Department (M/F/D)

Stellenbeschreibung:

Creation, review, and updating of SOPs in the area of clinical trial materials, including organization and optimization of processes as part of the reorganization
Updating, reviewing, and negotiating Quality Agreements and Responsibility Allocation Agreements
Review of relevant documents for the release of IMPs, particularly batch record review
Project-related consulting on deviations in the area of clinical trial materials
Consulting on change and CAPA management in the area of clinical trial materials
Handling of complaints in the area of clinical trial materials
Subject matter contribution to project activities as agreed with the supervisor
Consulting during audits and inspections as agreed with the supervisor
Performing administrative tasks and implementing quality management activities, particularly where GxP requirements necessitate execution by production-independent personnel
Independent preparation of training plans in the relevant area as well as planning trainings in TMDB according to instructions from the respective supervisor; consulting on the organization of trainings via TMDB

Several years of professional experience in a GxP-regulated environment
Detailed GMP knowledge related to the tasks described above
Advanced knowledge of national and international pharmaceutical law (such as AMG, EU-GMP, etc.)
Basic knowledge of GLP/GDP/GCP
Knowledge of data processing
Very good English and German skills
Ability to realistically assess and evaluate complex processes and situations
Accuracy and reliability