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
IRUBIS is a company that specializes in mid-infrared (MIR) spectroscopy for bioprocessing. We have designed an instrument, Monipa, specifically for bioprocess monitoring and control. Monipa is based on MIR spectroscopy, making it possible to monitor multiple bioprocesses in real-time and continuously. Our instrument's applications are foreseen in both upstream and downstream bioprocessing. These include multiple metabolite monitoring and control in upstream processing. In addition, contaminant detection or monitoring of target proteins and excipients can be aided in downstream processing.