GMP Quality & Compliance Specialist

FLBD FUJIFILM Life Sciences Biotechnologies Denmark ApS; Hillerød; On-site; DKK 520,000 - 750,000; Full time

Benefits offered by this job

Competitive pay

Growth opportunities

Fitness facilities

Canteen

Job summary

FLBD FUJIFILM Life Sciences Biotechnologies Denmark ApS in Denmark is seeking a Quality & Compliance professional to ensure GMP level production and timely batch release. You will handle deviations, changes, GEMBA walks, SOP updates, and CAPAs while collaborating with production in a fast-paced, international setting.

The role requires cGMP experience, data-driven analysis, and strong communication in Danish and English, with opportunities to drive continuous improvements and audits.

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.
• You are familiar with complex quality processes and have experience from regulated GMP areas.
• Analyzing data and creating complicated overviews and visualizing data driven patterns.
• Excellent business communication skills, both in Danish and English.

Responsibilities

• Collaboration with production on site GMP related tasks such as changes, SOP & Work Instructions creation & maintenance, etc.
• Writing deviations using SPS with A3 tool
• Facilitate A3 meetings and investigate root causes
• Daily Shopfloor in production
• Classification of deviations picked up on shop floor
• Preparing, writing CAPAs for board presentation
• Closing deviation 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 in the department.
• Participation in ad hoc projects.

Skills

GMP knowledge

Deviation handling

SOP writing

GEMBA walks

Data analysis

Quality mindset

Education

Bachelor in engineering, science, pharmacy or similar

Job description

FLBD FUJIFILM Life Sciences Biotechnologies Denmark ApS in Denmark is seeking a Quality & Compliance professional to ensure GMP level production and timely batch release. You will handle deviations, changes, GEMBA walks, SOP updates, and CAPAs while collaborating with production in a fast-paced, international setting.

The role requires cGMP experience, data-driven analysis, and strong communication in Danish and English, with opportunities to drive continuous improvements and audits.