Remote Deviation Investigator – GMP/QA Problem Solver

Fujifilm; Hillerød; Híbrido; DKK 550.000 - 700.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote work 1 day per week

Descripción de la vacante

FUJIFILM Biotechnologies Denmark in Hillerød seeks a Deviation Investigator to drive rigorous investigations and cross-functional problem solving. You will coordinate activities across Operations, QA, Engineering and Validation, and deliver GMP-compliant documentation.

Remote work is available one day per week, with a focus on timely progression of multiple investigations in a fast-paced manufacturing environment.

Formación

• Bachelor's or Master's degree in Engineering, Science, Pharmacy, Biotechnology, or a related discipline.
• Experience in a GMP-regulated manufacturing environment is preferred.
• Experience with deviation investigations, root cause analysis, and quality systems is an advantage.
• Strong systematic and analytical problem-solving skills.
• Ability to manage multiple investigations and priorities simultaneously.
• Structured and detail-oriented approach to work.
• Strong facilitator and stakeholder management skills.
• Self-driven with a proactive mindset.
• Excellent communication and collaboration skills.
• Ability to maintain momentum and ensure progress across multiple ongoing activities.
• Comfortable working in a fast-paced manufacturing environment.

Responsabilidades

• Lead and facilitate deviation investigations to closure.
• Ensure deviations progress according to agreed timelines and quality standards.
• Coordinate investigation activities with SMEs and stakeholders across Operations, QA, Engineering, Validation, and other functions.
• Drive structured root cause analysis using systematic problem-solving methodologies.
• Collect, analyze, and document investigation data and evidence.
• Support determination of CAPAs and GMP-compliant documentation.
• Contribute to continuous improvement of investigation processes and practices.

Conocimientos

Root cause analysis

Stakeholder management

Facilitation

Problem solving

Structured problem-solving

Communication

Multitasking

Educación

Bachelor's or Master's degree in Engineering/Science/Pharmacy/Biotechnology

Descripción del empleo

FUJIFILM Biotechnologies Denmark in Hillerød seeks a Deviation Investigator to drive rigorous investigations and cross-functional problem solving. You will coordinate activities across Operations, QA, Engineering and Validation, and deliver GMP-compliant documentation.

Remote work is available one day per week, with a focus on timely progression of multiple investigations in a fast-paced manufacturing environment.