Process, assess, and decide on quality incidents during manufacturing, release, packaging / labelling, and distribution of investigational medicinal products (IMPs)
Manage and drive different kinds of quality incidents together with globally organized functional departments and with external partners
Develop and improve the internal quality processes and the supporting IT systems
Responsible to present quality incidents in management meetings, audits, and inspections
Contribute to international and interdisciplinary quality working groups and ensure that deliverables are achieved
Was Sie mitbringen:
Bachelor degree or professional training with additional qualification (e. g. "Industriemeister")
Several years of practical and proven experience in drug manufacturing or analytics, quality assurance and/or development in the pharmaceutical industry
Advanced knowledge of development processes for investigational medicinal products as well as in-depth knowledge of cGMP regulations for IMPs
Expert knowledge of health authorities’ requirements (cGMP regulations e.g., EU-GMP Guide, CFR etc.)
Conceptual thinking, high customer focus and result orientation
Strong oral and written communication skills in English and German
There are many reasons to work at Bertrandt: Diverse projects with people, ideas and perspectives. There is no success without a strong team.
Der Bertrandt-Konzern bietet seit über 40 Jahren Entwicklungslösungen für die internationale Automobil- und Luftfahrtindustrie sowie die
Branchen Maschinen- und Anlagenbau, Energie, Medizintechnik und Elektroindustrie in Europa, China und den USA. Insgesamt stehen unsere
Mitarbeiterinnen und Mitarbeiter für tiefes Know-how, zukunftsfähige Projektlösungen und hohe Kundenorientierung.
