IRUBIS GmbH is a life science tools startup that pioneers real-time bioprocess analytics with mid-infrared (MIR) spectroscopy. Our mission is to revolutionize bioprocess monitoring and control with innovative and user-friendly tools, enabling the next generation of biopharmaceutical production. To support our growth and meet the high standards of our clients, we are building a Quality Management System according to ISO 9001 and ensuring GMP readiness.
Tasks
* Establishing and implementing an ISO 9001-compliant QMS
* Ensuring GMP requirements (esp. data integrity, documentation, software validation)
* Creating, maintaining, and training quality processes, SOPs, and manuals
* Preparing and supporting internal and external audits
* Setting up processes for CAPA, deviations, change control, and supplier management
* Collaborating closely with internal teams (R&D, Production, Service) and external partners
Requirements
* Proven track record in developing and implementing ISO 9001-compliant QMS
* Solid expertise in GMP environments (pharma, biotech, medtech, or suppliers)
* Familiar with Annex 11 / 21 CFR Part 11, CSV/CSA approaches, and data integrity (ALCOA+)
* Hands-on experience with audits and certification processes
* Pragmatic, structured approach and ability to drive solutions efficiently
* Strong communication skills in German and English
Benefits
* Modern office space: centrally located in Munich
* Flexible working hours, a great team and flat hierarchies
* Exciting personal development opportunities
* Stay fit and energized with EGYM Wellpass access, fruit basket and refreshing drinks
* Company events: enjoy summer parties, traditional Wiesn visits, and our annual Christmas celebration!
Does it all sound interesting to you? Then send us your curriculum vitae without a personal photo in a PDF document.
Location: Bayerstraße 85a, 80335 Munich
Start time: Flexible