GMP Quality & Compliance Specialist - Shopfloor

FujiFilm; Hillerød; On-site; DKK 520,000 - 760,000; Full time

Job summary

FUJIFILM Biotechnologies Denmark in Hillerød seeks a Quality & Compliance professional to drive GMP excellence in a fast-paced, international production environment. You’ll manage deviations, CAPAs, and SOPs, partner with operators, and ensure timely batch releases and audits.

You’ll bring a bachelor-level engineering/science/pharmacy background, 2+ years in cGMP, and strong data skills to visualize patterns and support continuous improvements.

Qualifications

• Bachelor degree in engineering, science, pharmacy or similar.
• 2+ years experience in cGMP/pharmaceutical manufacturing.
• Familiar with complex quality processes and regulated GMP areas.
• Analyzing data and creating overviews and visualizing data driven patterns.
• Excellent business communication in Danish and English.

Responsibilities

• Collaborate with production on GMP-related tasks such as changes and SOP creation.
• Write deviations using SPS with A3 tool.
• Facilitate A3 meetings and investigate root causes.
• Daily shopfloor in production.
• Prepare CAPAs for board presentations.
• Closing deviations in time for batch release.
• Participating in audits/inspections where relevant.
• General support with compliance related tasks.
• Drive and coordinate quality improvements.
• Support GMP training and contribute to the understanding of GMP.
• Participation in ad hoc projects.

Skills

cGMP experience

Quality systems

Data visualization

Data analysis

English proficiency

Danish proficiency

Education

Bachelor in engineering/science/pharmacy

Job description

FUJIFILM Biotechnologies Denmark in Hillerød seeks a Quality & Compliance professional to drive GMP excellence in a fast-paced, international production environment. You’ll manage deviations, CAPAs, and SOPs, partner with operators, and ensure timely batch releases and audits.

You’ll bring a bachelor-level engineering/science/pharmacy background, 2+ years in cGMP, and strong data skills to visualize patterns and support continuous improvements.