IT/OT Quality Specialist – 6 Month Paternity Leave Cover

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

About the Department

The QA Digital Technologies (QADT) team is growing and currently exists of 13 colleagues with lots of energy and genki. Our culture is all about collaboration and dialog. As a member of the QA Digital Technologies (QADT) team, you will not only become part of a fantastic team, but also become part of a QA team partnering with our global IT department and local Automation team together with a broad range of stakeholders throughout the Hillerød Site as well as globally.

About the Position

You will support a global initiative to develop a package of global SOPs, work instructions and templates supporting processes across the IT organization. The tasks will include:

• 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

Qualifications

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

Your Application

This is a 6-month paternity leave cover starting 1 January 2027.

Working at FUJIFILM Biotechnologies

We offer a competitive compensation package in a site/company growing rapidly, with many opportunities for individual growth.

We also offer access to fitness and an attractive canteen.

FUJIFILM Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA. We use our skills, dedication, and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products—enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives. Our Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities, and technologies to manufacture advanced biologics.

As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy—what we call Genki—to join our team. We offer the chance to be part of a global workplace where passion, drive, and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone—no matter their background or gender—has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.

We aim to foster a collaborative, innovative, and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.

FUJIFILM Biotechnologies Denmark is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identity, or any other protected class.