GMP Quality & Compliance Specialist – Fast-Paced Biotech

FUJIFILM Diosynth Biotechnologies; Hillerød; On-site; DKK 420,000 - 640,000; Full time

Benefits offered by this job

Fitness access

Canteen facilities

Competitive compensation

Job summary

FUJIFILM Biotechnologies Denmark seeks a quality and compliance professional to enforce GMP standards on a fast-paced production site in Hillerød. You will understand the QMS system, perform GMP/QMS tasks, and ensure timely batch release by handling deviations, CAPAs and changes, while writing SOPs and supporting audits.

Ideal candidates have a Bachelor in science/engineering or pharmacy with 2+ years of cGMP experience, a proactive mindset and strong collaboration skills to optimize production

Qualifications

• Experience with cGMP and pharmaceutical manufacturing.
• Familiarity with GMP/QMS tasks and quality systems.
• Ability to handle deviations, CAPAs and changes in a fast-paced environment.

Responsibilities

• Collaborate with production on site to ensure GMP compliance.
• Create and maintain SOPs and Work Instructions.
• Write deviations using structured tools and manage CAPAs for timely batch release.
• Support audits/inspections and contribute to continuous improvement.
• Perform GEMBA walks and drive quality improvements across the line.

Skills

GMP experience

cGMP

QMS

SOP writing

CAPA management

Root cause analysis

Education

Bachelor's degree in engineering/science/pharmacy

Job description

FUJIFILM Biotechnologies Denmark seeks a quality and compliance professional to enforce GMP standards on a fast-paced production site in Hillerød. You will understand the QMS system, perform GMP/QMS tasks, and ensure timely batch release by handling deviations, CAPAs and changes, while writing SOPs and supporting audits.

Ideal candidates have a Bachelor in science/engineering or pharmacy with 2+ years of cGMP experience, a proactive mindset and strong collaboration skills to optimize production