Global IT/OT Quality & SOPs Specialist

FLBD FUJIFILM Life Sciences Biotechnologies Denmark ApS; Hillerød; Sur place; DKK 600 000 - 750 000; Plein temps

Avantages offerts par ce poste

Fitness access

Canteen facilities

Career development opportunities

Résumé du poste

FLBD FUJIFILM Life Sciences Biotechnologies Denmark ApS is seeking a QA Documentation Specialist on a 6‑month paternity leave cover in Hillerød. You will help develop SOPs, WIs and templates across IT and QA teams, supporting global processes and local validation activities.

You will collaborate with global partners, SMEs and QAs to consolidate existing documents, explain new processes, and ensure alignment with GxP requirements. Fluent English and strong communication are essential.

Qualifications

• Well-versed in GMP regulations/processes, including 21 CFR Part 11 and Data Integrity.
• Knowledge of IT and CSV methodologies, including GAMP5 and ITIL.
• Collaborative mindset with a willingness to integrate into the team and organisation.
• Minimum 5 years of work experience or educational background allowing understanding of complexity of computerized system validation across GxP.
• Minimum 1 year of work experience in writing procedural documents for GxP processes.
• Ability to work in a dynamic environment and build the road as we go.
• Self-driven, excellent communication skills and ability to create structure.
• Speak and write English fluently.

Responsabilités

• Collaborating with global IT, CSV and Quality partners in writing and reviewing global SOPs, WIs and templates.
• Supporting local SMEs and QAs in review or consolidation of existing local SOPs and WIs for computerized systems.
• Facilitating sessions explaining new processes to other IT/OT QAs.

Connaissances

GMP regulations

GxP understandings

English fluency

Strong communication

Self-driven

Collaboration

Outils

GAMP5

ITIL

CSV methodologies

Description du poste

FLBD FUJIFILM Life Sciences Biotechnologies Denmark ApS is seeking a QA Documentation Specialist on a 6‑month paternity leave cover in Hillerød. You will help develop SOPs, WIs and templates across IT and QA teams, supporting global processes and local validation activities.

You will collaborate with global partners, SMEs and QAs to consolidate existing documents, explain new processes, and ensure alignment with GxP requirements. Fluent English and strong communication are essential.