Quality Manager (All genders | Full time | Fixed 6 to 12 months contract)

Munich - Germany

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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