About us
IRUBIS is a young, growing biotechnology start-up specializing in monitoring and control of bioprocesses. We are building a state-of-the-art system, Monipa, to provide our biopharma customers with information about their bioprocesses in the lab, in the office, at home, and at any time. 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. The role is a fixed-term position, with a contract duration of 6 to 12 months.
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
What we offer
- 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, Jobrad partnership, fruit basket, and refreshing drinks
- Company events: enjoy summer parties, traditional Wiesn visits, and our annual Christmas celebration!
Does all sound interesting to you? Then send us your curriculum vitae without a personal photo in a PDF document.