Do you have experience with computer system validation and lifecycle activities across GxP areas and do you have the ability to work in a very dynamic environment with a clear sense of urgency? Do you bring loads of energy and thrive to work with a broad range of stakeholders? Then you might be the person we are looking for!
We are currently looking for an IT Quality Specialist to join the QA Digital Technologies team based in Hillerød, Denmark.
About the Team
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 Digital Technologies department consisting of IT, Automation and business Intelligence. You will take part in projects implementing and/or upgrading computer systems, lifecycle activities, and contribute to global QA alignment on CSV and lifecycle tasks.
Furthermore, you will take part in the continiuous development and maintenacne of the quality systems reated to IT and Automation based on current GMP and regulatory requirments.
About the Role
- Perform QA support to our Digital Technologies department on CSV matters; Review and approve system development and life cycle artefacts, validation and change control documentation for computerized systems supporting GxP processes.
- Ensure procedures and methodologies are followed, and that appropriate and complete documentation is captured and reported. Act as quality partner by providing guidance, training and ad hoc support to stakeholders herewith.
- Represent QADT on assigned computerized systems projects.
- Employ risk-based methodology and support develop and implement validation strategies for computer systems – also focusing on business processes and data integrity.
- Take part in local and global alignment tasks within IT quality and CSV.
- Maintain internal training level and keep up to date on cGMPs and regulatory requirements as well as on global procedures, guidelines, policies, frames, and specifications
- Collaborative mindset with a willingness to integrate oneself in the team and organisation
- Well-versed in GxP guidance, including 21 CFR Part 11, Annex 11 and Data Integrity
- Knowledge of IT Controls methodologies, including GAMP5 and ITIL.
- Experience with computerized system validation across GxP systems.
- Ability to work in a very dynamic environment and thrive building the road as we go.
- Self-driven, excellent communication skills and at good at creating structure
- 3-5 years of work experience or educational background that allows for understanding of the complexity of manufacturing biologics
- Speak and write English fluently
Educational background comes second, but could be within the following areas:
Bachelor's or Master’s Degree of Science in IT or Natural science, e.g. Pharmacy, Biotechnology, Biology, Engineering or similar.
Please upload your CV and cover letter as soon as possible as we screen applications on an ongoing basis.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.