Temporary until 30.06.2027
Coordination of qualification projects for production in compliance with applicable GMP regulations
Planning and coordination of activities for the qualification, validation and commissioning of new production facilities
Preparation of all necessary qualification and validation documents for the production area
Carrying out the qualification and validation of pharmaceutical systems and processes
Processing changes (change controls) and deviations
Creating standard operating procedures (SOPs)
Monitoring the quality and timely implementation of individual qualification projects
Support with annual requalifications, revalidations and plant reviews
Communication as an interface between production, Q-Unit and IT
Support during inspections: Presentation of the above-mentioned processes and project-specific qualification activities
Preparation and implementation of internal audits
Collaboration in the continuous development of qualification and validation concepts
Completed studies in the natural sciences or technical field
Several years of professional experience in a GMP-regulated environment
Knowledge of the regulatory requirements for the manufacture and testing of sterile medicinal products
First professional experience in the field of qualification and validation in the pharmaceutical industry
First experience in the field of manufacturing, quality control or quality assurance of sterile medicinal products and medical devices
Initial experience in project management
High sense of responsibility and reliability
Strong analytical and evaluation skills as well as process and quality orientation
High level of communication and cooperation skills
Affinity for automated processes
Very good written and spoken German and good English skills
We offer you an exciting working environment and a position that could well be the starting point for further development in our company, as well as the opportunity to make a valuable contribution to improving the quality of life of sick people all over the world. We are a company bound by collective agreements with numerous benefits such as an employer-financed pension scheme and accident insurance, free employee parking, employee discount programs, a canteen with a meal allowance, an occupational health service with many free services and much more!
As long as the job ad is online, you can apply quickly and easily.
At Fresenius, we are convinced that combining different perspectives, opinions, experiences, cultures and values enables us to harness the potential that will make us even more successful. All job applicants are welcome.
All terms used in this job advertisement to denote persons refer to all genders equally.
When it’s not just a job, but your calling. When you have an impact on people’s lives every day. When you can’t imagine doing something else. Then you know it’s Fresenius.