Quality Manager (All genders | Full time | Fixed 6 to 12 months contract)
Quality Manager (All genders | Full time | Fixed 6 to 12 months contract)
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Job Description
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: Bayerstrae 85a 80335 Munich
Start time: Flexible
Employment Type
Full Time
