IT/OT Quality Specialist – CSV, GxP & SOPs Lead

Fujifilm; Hillerød; Sur place; DKK 600 000 - 800 000; 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 global initiative developing SOPs, WIs and templates across IT/CSV. The role requires validating computerized systems in a GMP environment and collaborating with global partners to ensure data integrity.

The position is based in Hillerød, Denmark, for a 6-month paternity cover. You will engage with local SMEs and QAs, facilitate trainings, and help establish new processes in a dynamic, fast-paced setting.

Qualifications

• Solid GMP/GxP knowledge and experience with validation across GxP systems.
• Familiarity with 21 CFR Part 11, Eudralex Annex 11, and Data Integrity.
• Experience writing and reviewing SOPs, WIs and templates for IT/CSV processes.
• Strong communication and collaboration across global partners.

Responsabilités

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

Connaissances

GxP knowledge

GMP regulations

GAMP5

ITIL

Communication

Collaborative mindset

Self-driven

English fluency

Description du poste

FUJIFILM Biotechnologies Denmark is seeking an IT/OT Quality Specialist to support a global initiative developing SOPs, WIs and templates across IT/CSV. The role requires validating computerized systems in a GMP environment and collaborating with global partners to ensure data integrity.

The position is based in Hillerød, Denmark, for a 6-month paternity cover. You will engage with local SMEs and QAs, facilitate trainings, and help establish new processes in a dynamic, fast-paced setting.