* Participation in the maintenance and further development of our QS system
(GMP)
* Participation in the further development of the document management
system as part of the implementation of an electronic management system
* Creation, testing, management and archiving of GMP-relevant documents
such as SOPs, forms and specification documents
* Recording and processing of deviations as part of deviation management as
well as processing and cross-departmental tracking of corrective and preventive
measures (CAPA management)
* Coordination of risk management and implementation of risk analysis
* Conducting the batch record review
* Preparation of the annual Product Quality Report
Your skills:
* University degree in natural sciences (pharmacy, chemistry, biology or
comparable)
* several years of professional experience in the field of pharmaceutical quality
assurance is desirable but not a prerequisite
* Knowledge of relevant regulations such as AMG, AMWHV, EU GMP guidelines
* Willingness to learn, an open-minded personality, a conscientious and precise
working style, as well as a high degree of personal responsibility and commitment
* Competent handling of Microsoft Office applications
* Excellent knowledge of German and very good knowledge of spoken and
written English
