GMP Quality & Compliance Specialist

FUJIFILM Biotechnologies; Hillerød; On-site; DKK 450,000 - 700,000; Full time

Benefits offered by this job

Fitness facilities

Canteen

Job summary

FUJIFILM Biotechnologies Denmark is seeking a Quality & Compliance professional to partner with production in a fast-paced GMP environment. You will handle deviations, CAPAs, and changes, perform GEMBA walks, and keep SOPs sharp to secure timely batch release.

You will work with the Manufacturing Support team in Hillerød to apply data-driven analyses, drive quality improvements, and participate in audits to support continuous GMP/QMS operations.

Qualifications

• Educational background is preferably a Bachelor within engineering, science, pharmacy or similar.
• Experience with cGMP and pharmaceutical manufacturing
• Preferably 2+ years in the industry.
• Familiar with complex quality processes in regulated GMP areas.
• Analyzing data and creating overviews with data-driven patterns.
• Excellent business communication skills in Danish and English.

Responsibilities

• Collaboration with production on site and GMP-related tasks such as changes, SOP & Work Instructions creation & maintenance.
• Writing deviations using SPS with A3 tool; facilitate A3 meetings and investigate root causes.
• Daily shopfloor presence in production and classification of deviations.
• Prepare, write CAPAs for board presentation and ensure timely batch release.
• Participating in audits/inspections and supporting GMP training.

Skills

Quality & Compliance

GMP

Data analysis

Communication (Danish & English)

Education

Bachelor in engineering, science, pharmacy or similar

Tools

SPS with A3 tool

Job description

FUJIFILM Biotechnologies Denmark is seeking a Quality & Compliance professional to partner with production in a fast-paced GMP environment. You will handle deviations, CAPAs, and changes, perform GEMBA walks, and keep SOPs sharp to secure timely batch release.

You will work with the Manufacturing Support team in Hillerød to apply data-driven analyses, drive quality improvements, and participate in audits to support continuous GMP/QMS operations.