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

Mdcrecruiting

Unterschleißheim, Germany
Hybrid
Regulatory activities planning and coordination
Change request initiation and coordination
Status overview creation and tracking
Our Quality Assurance ensures 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 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 act as the world's most reliable manufacturer and supplier of biopharmaceuticals.

Matching Summary

Our Quality Assurance ensures 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 request initiation and coordination
  • Status overview creation and tracking
  • Specification creation
  • Regulatory commitments creation and tracking
  • Product Quality Reviews
  • Material data and test plan maintenance
  • Authority inspection support

Nice-to-have

  • Experience in Regulatory Affairs
  • Experience in GMP environment
  • Proactive and solution-oriented action
  • Strong communication skills
  • High team spirit

Key Requirements

  • Completed degree in natural sciences (e.g., Pharmacy, Food Technology, Chemistry, Biology) or comparable education
  • Very good English and German language skills
  • Very good Microsoft Office knowledge

Work Rights

Not specified

Tailored Resume

Cover Letter