Experienced Cgmp Specialist For Facility Management – Experienced Within Audit Readiness, Regulatory Requirements, And Audits
Fujifilm
Hillerød, Denmark
Fully remote
Cgmp compliance and audit readiness
Facility management compliance
Regulatory inspections and audits
You will act as the Subject Matter Expert for Facility Management compliance, ensuring sustained inspection readiness, robust documentation, and effective CAPA management across multiple operational areas
Job Summary
You will act as the Subject Matter Expert for Facility Management compliance, ensuring sustained inspection readiness, robust documentation, and effective CAPA management across multiple operational areas.
The position offers flexibility and the possibility to work from home when on-site presence is not required, within a team that values quality, patient safety, and results.
FUJIFILM Biotechnologies is deeply committed to diversity and inclusion and offers a competitive compensation package along with opportunities for professional and personal development.
Matching Summary
You will act as the Subject Matter Expert for Facility Management compliance, ensuring sustained inspection readiness, robust documentation, and effective CAPA management across multiple operational areas.
Skills & Requirements
Must-have
cGMP compliance and audit readiness
Facility Management compliance
Regulatory inspections and audits
CAPA management and follow-up
Risk assessments (ICH Q9)
SOPs and documentation management
Collaboration with QA and Regulatory
Nice-to-have
Continuous improvement mindset
Strong communication and collaboration
Digitalization and standardization initiatives
Fluent in English and Danish
Proactive and structured work style
Experience with cleanrooms and utilities
Key Requirements
5+ years cGMP experience in pharma/biotech
Experience with regulatory inspections and third-party audits