As an expert in qualification and validation, you will carry out qualification and validation activities of pharmaceutical plants and equipment in compliance with current national and international GMP regulations, regulations and guidelines.
Plan and coordinate activities for qualification, validation and
Commissioning of production facilities and processes and subsequent implementation
Preparation of all necessary qualification documents for the production area
Support with annual requalifications, revalidations (e.g. autoclaves) and plant reviews
Editing changes (change controls) and deviations
Creation of Standard Operating Procedures (SOP's)
Communication as an interface between production, Q-Unit and IT
Support in inspections: Presentation of the above-mentioned processes as well as project-specific qualification activities
Checking calibration instructions and particle measurements
Preparation and implementation of internal audits and GMP inspections
Participate in the local implementation of global systems and policies to optimize qualification and validation processes
Degree in the natural sciences or technology
Several years of professional experience in a GMP-regulated environment
Knowledge of the regulatory requirements for the production and testing of sterile medicinal products
First professional experience in the field of qualification and validation in the pharmaceutical industry as well as in the field of manufacturing, quality control or quality assurance of sterile drugs and medical devices
Initial experience in the field of project management is an advantage
High sense of responsibility and reliability as well as personal responsibility
Strong analytical and evaluation skills as well as communication and cooperation skills
Process and quality orientation and affinity for automated processes
IT affinity and routine use of MS Office programs
Very good knowledge of German and good English, both written and spoken
We offer you an exciting working environment and a position that can 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 around the world with us. We are a company bound by collective bargaining agreements with numerous benefits such as employer-financed pension schemes and accident insurance, free employee parking, employee discount programs, a canteen with meal allowance, an occupational health service and many other benefits!
Shape the future together with us – become part of #futurefresenius and apply now via our online portal!