Specialist Quality Systems And Regulatory Compliance (m/w/d) – Befristet Auf 2 Jahre

microsatsystems.biz

Unterschleißheim, Germany
Hybrid
Regulatory activities planning and coordination
Change control initiation and coordination
Regulatory status tracking and reporting
Our quality assurance ensures that all materials and substances in our products are manufactured, processed, tested, packaged, stored, and delivered in compliance with our strict quality standards and all regulatory requirements

Job Summary

  • Our quality assurance ensures that all materials and substances in our products are manufactured, processed, tested, packaged, stored, and delivered in compliance with our strict quality standards and all regulatory requirements.
  • We are looking for a Specialist Quality Systems and Regulatory Compliance (m/f/d) at the Unterschleißheim site.
  • The stated goal of our Production & Delivery business unit is to be the world's most reliable manufacturer and supplier of biopharmaceuticals.

Matching Summary

Our quality assurance ensures that all materials and substances in our products are manufactured, processed, tested, packaged, stored, and delivered in compliance with our strict quality standards and all regulatory requirements.

Skills & Requirements

Must-have

  • regulatory activities planning and coordination
  • change control initiation and coordination
  • regulatory status tracking and reporting
  • specification and commitment creation
  • SAP material data and test plan maintenance
  • authority inspection support

Nice-to-have

  • proactive and solution-oriented approach
  • strong communication and teamwork skills
  • integrative and diverse work environment

Key Requirements

  • Degree in natural sciences or comparable education
  • Experience in Regulatory Affairs desirable
  • Experience in GMP environment desirable
  • Very good English and German language skills
  • Very good Microsoft Office knowledge

Work Rights

Not specified

Tailored Resume

Cover Letter