Specialist Quality Assurance GMP (m / w / d)

Specialist Quality Assurance GMP (m / w / d)

1. In your role as Specialist Quality Assurance GMP, you will process, assess, and decide on quality incidents during manufacturing, release, packaging/labelling, and distribution of investigational medicinal products (IMPs).
2. You will manage and drive various quality incidents in collaboration with globally organized functional departments and external partners.
3. You will further develop and improve internal quality processes and supporting IT systems.
4. You are responsible for presenting quality incidents in management meetings, audits, and inspections.
5. Additionally, you will contribute to international and interdisciplinary quality working groups and ensure that deliverables are achieved.
6. Qualifications include a Bachelor’s degree or professional training with additional qualification (e.g., "Industriemeister (m / w / d)").
7. Several years of practical experience in drug manufacturing, analytics, quality assurance, or development within the pharmaceutical industry are required.
8. Advanced knowledge of development processes for investigational medicinal products and in-depth understanding of cGMP regulations for IMPs.
9. Expertise in health authorities’ requirements (e.g., EU-GMP Guide, CFR) is essential.
10. Must possess conceptual thinking, high customer focus, and result orientation.
11. Strong oral and written communication skills in English and German are required.