Coordinating and ensuring the implementation of all validation, qualification and optimization activities in quality control
Planning, coordination and evaluation of analytical method validations
Support in the development of new and optimization of existing methods
Planning and coordination of analytical device qualifications
Preparation of method verification, method validation and device qualification documentation
Preparation of the necessary documents, e.g. regulations and addenda, and preparation of test plan long texts in cooperation with the responsible persons in the laboratory
Agreement of quality agreements and creation of test orders outside SAP
Supporting the creation and review of approval documents and responding to notices of defects
Support in other quality control processes such as periodic method review
Completed university degree in pharmacy, chemistry or similar (chemical engineering, food chemistry, biology) or comparable qualification
At least 2 years of professional experience in quality control / quality assurance in a pharmaceutical production facility
Experience in chemical and physical analysis, especially in the area of method development and method transfer
Sound knowledge of legal regulations of the German Drug Law, the German Drug and Active Substance Manufacturing Ordinance, the EU guidelines for good manufacturing practice, the US cGMP requirements
Sound knowledge of pharmacopoeia method testing
Experience in dealing with the European Pharmacopoeia and the United States Pharmacopeia
Sound knowledge of product quality requirements for raw materials and medicinal products
Good written and spoken German and English skills
Negotiating skills, organizational talent and process orientation
High sense of responsibility and reliability
Good analytical and evaluation skills as well as well-developed communication and teamwork skills
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.