Sr. IT Quality Specialist, Hillerød, Denmark
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Hillerød
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
Qualifications
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.
Your Application
Please upload your CV and cover letter as soon as possible as we screen applications on an ongoing basis:
https://fujifilmdiosynth.wd3.myworkdayjobs.com/en-US/External/details/QA-DSM-Execution-Systems---ITQ-Associate_JR1388
About FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth 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 site in Hillerød, Denmark, brings together expertise, capabilities and technologies to manufacture advanced biologics. The large scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. We commenced 6 billion DKK projects to double our manufacturing capacity and to add fill finish to the site.
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.
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.
www.fujifilmdiosynth.com
Kilde: Jobnet.dk
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
Qualifications
- 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.
Your Application
Please upload your CV and cover letter as soon as possible as we screen applications on an ongoing basis:
https://fujifilmdiosynth.wd3.myworkdayjobs.com/en-US/External/details/QA-DSM-Execution-Systems---ITQ-Associate_JR1388
About FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth 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 site in Hillerød, Denmark, brings together expertise, capabilities and technologies to manufacture advanced biologics. The large scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. We commenced 6 billion DKK projects to double our manufacturing capacity and to add fill finish to the site.
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.
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.
www.fujifilmdiosynth.com
Kilde: Jobnet.dk
Information og data
Denne ledige stilling har jobtypen "Softwareudvikler", og befinder sig i kategorien "Informationsteknologi".
Arbejdsstedet er beliggende i Hillerød.
Jobbet er oprettet på vores service den 9.5.2022, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Softwareudvikler
- Hillerød
- Mandag den 04. juli 2022
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