* Monitoring, coordination, management and evaluation of quality assurance processes
(deviations, CAPA, change controls, complaints and testing).
* Technical support to factories on issues related to GMP compliance.
* Organisation and support of internal and external audits and inspections, as well as
coordination and implementation of resulting actions.
* Preparation and updating of standard operating procedures and forms.
* Monitoring GMP production and GMP behaviour in the production area of the facilities.
* Development of content and implementation of GMP training courses.
* Identification and implementation of measures for improvement/development of quality
management processes.
* Recording, monitoring and evaluation of reporting systems, e.g. non-conformity, CAPAs.
* Regular reporting to the management of the quality assurance team
Requirements profile:
* Scientific, commercial or comparable education
* Several years of professional experience in a pharmaceutical environment
* Knowledge of German and European regulations for the production of pharmaceuticals and
medical devices, especially good knowledge of GMP regulations.
* Familiarity with the EU Medical Device Regulation 2017/745 (MDR), DIN EN ISO 13485 and DIN
EN ISO 9001.
* Independent, reliable and structured working method
* Strong implementation skills, ability to work under pressure and high flexibility.
* Diligence, initiative and good communication skills
* Interdisciplinary and holistic thinking
* Good computer skills, in particular SAP
* Good knowledge of written and spoken English
