QMS Expert (all genders) - part-time possible

at  Merck Group

Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That’s why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
As an integral member of our Site Quality Darmstadt Development Unit, you will be accountable for site regulatory compliance activities, provision of manufacturing and import authorization documents. In addition, you will be involved in site Supplier/CDMO management activities.

• Review and update of change controls in the context of the manufacturing and import authorization
• Maintaining Site Master File, prepare and update related SOPs
• Supplier / CDMO management including qualification and monitoring, negotiation of QTAs
• Review & Tracking of CDMO GMP licences and QP Statements
• Representative towards Interfaces regarding regulatory compliance topics