IT/OT Quality Specialist — CSV & GxP Expert

FUJIFILM Biotechnologies; Hillerød; Sur place; DKK 600 000 - 900 000; Plein temps

Avantages offerts par ce poste

Fitness access

Canteen

Résumé du poste

FUJIFILM Biotechnologies Denmark is seeking an IT/OT Quality Specialist to support a 6-month paternity leave cover starting 1 January 2027 in the QA Digital Technologies team based in Hillerød, Denmark.

You will collaborate with global IT, CSV and Quality partners to develop global SOPs, WIs and templates for processes across the IT organization, while supporting local SMEs and QAs in consolidating existing SOPs for computerized systems. English fluency is required.

Qualifications

• Well-versed in GMP regulations and data integrity.
• Knowledge of IT and CSV methodologies including GAMP5 and ITIL.
• Collaborative mindset and ability to integrate into a team and organization.
• Minimum 5 years of work experience or equivalent educational background in validated systems.
• Minimum 1 year writing procedural documents for GxP processes.
• Ability to thrive in a dynamic environment and contribute to process evolution.

Responsabilités

• Collaborate with global IT, CSV and Quality teams to write and review global SOPs, WIs and templates.
• Support local SMEs and QAs in reviewing and consolidating local SOPs and WIs for computerized systems.
• Lead or facilitate sessions to explain new processes to IT/OT QAs.

Connaissances

GMP compliance

ITIL knowledge

Collaborative mindset

Strong communication

Self-driven

English fluency

Formation

Experience with GxP systems

Outils

GAMP5

CSV methodologies

Description du poste

FUJIFILM Biotechnologies Denmark is seeking an IT/OT Quality Specialist to support a 6-month paternity leave cover starting 1 January 2027 in the QA Digital Technologies team based in Hillerød, Denmark.

You will collaborate with global IT, CSV and Quality partners to develop global SOPs, WIs and templates for processes across the IT organization, while supporting local SMEs and QAs in consolidating existing SOPs for computerized systems. English fluency is required.