Experienced Cgmp Specialist For Facility Management – Experienced Within Audit Readiness, Regulatory Requirements, And Audits

FUJIFILM Biotechnologies

Hillerød, Denmark
Fully remote
Cgmp specialist
Audit readiness program
Regulatory requirements
We seek an experienced cGMP Specialist to lead audit readiness for Facility Management, ensuring sustained inspection readiness, robust documentation, and effective CAPA management

Job Summary

  • We seek an experienced cGMP Specialist to lead audit readiness for Facility Management, ensuring sustained inspection readiness, robust documentation, and effective CAPA management.
  • The role includes close collaboration with QA, Production, Regulatory, EHS, and external partners, and active participation in customer and authority inspections.
  • We offer a competitive compensation package in a site/company growing rapidly, with many opportunities for individual growth, we also offer access to fitness and an attractive canteen.

Matching Summary

We seek an experienced cGMP Specialist to lead audit readiness for Facility Management, ensuring sustained inspection readiness, robust documentation, and effective CAPA management.

Skills & Requirements

Must-have

  • cGMP Specialist
  • audit readiness program
  • regulatory requirements
  • cleanrooms
  • cleaning and disinfection
  • pest control
  • maintenance
  • supplier oversight

Nice-to-have

  • challenging the status quo
  • simplifying where possible
  • elevating compliance level
  • continuous improvement mindset
  • healthy work-life balance
  • social activities

Key Requirements

  • 5+ years of documented cGMP experience
  • Solid experience with audit readiness
  • In-depth knowledge of EU GMP (incl. Annex 1)
  • 21 CFR Parts 210 and 211
  • Data integrity (ALCOA+)
  • Fluent in English and Danish

Work Rights

Not specified

Tailored Resume

Cover Letter