Fujifilm

Experienced cGMP Specialist for Facility Management – experienced within Audit Readiness, Regulatory Requirements, and Audits

Fujifilm

6 days ago
Hillerød
Hybrid
Full Time
Senior
0 applicants
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Fujifilm
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About this role

A cGMP Specialist leads audit readiness for Facility Management, ensuring compliance, documentation, and CAPA management across cleanrooms, cleaning, gowning, pest control, and supplier oversight. The role involves collaboration with QA, Production, Regulatory, EHS, and external partners to maintain inspection readiness.

Skills

Qualifications

5+ years of documented experience with cGMP in the pharma/biotech industryExperience with audit readiness, audit hosting, and management of observations and CAPAsIn-depth knowledge of EU GMP, EudraLex, 21 CFR Parts 210 and 211, data integrity (ALCOA+)Experience with FM-related GMP areas: cleanrooms, cleaning and disinfection, pest control, maintenance, utilities, supplier managementStrong process and quality understanding: deviations, change control, risk management (ICH Q9), validation/qualification
Fujifilm

About Fujifilm

fujifilm.com

At Fujifilm we create innovative products and deliver effective solutions in a wide variety of fields to serve society, contribute to the quality of life, and enhance environmental sustainability.

About Fujifilm

Headquarters

San Francisco, CA

Company Size

201-500 employees

Founded

2018

Industry

Technology

Glassdoor Rating

4.2 / 5

Leadership Team

Sarah Johnson

Chief Executive Officer

Michael Chen

Chief Technology Officer

Emily Williams

VP of Engineering

David Rodriguez

VP of Product

Jessica Thompson

Chief Financial Officer

Andrew Park

VP of Sales

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