Manufacturing Support – Documentation (Temporary)
Do you have the flair for compliance and can handle many stakeholders? Are you looking for a position where you can take on responsibility? We are looking for 2 colleagues for the Documentation Team in Drug Substance Manufacturing in Hillerød.
About the department
In the department Drug Substance Manufacturing (DSM) Support we are responsible for supporting manufacturing operations with project management and compliance of procedures and documentation. Manufacturing Support consist of approx. 50 employees in 3 teams.
In the DSM Documentation team, we provide procedural support to GMP manufacturing and ensure compliance and document release activities in a timely manner. We create and maintain the document package for Drug Substance Manufacturing (DSM) and perform procedural changes as well as assessing impact of events.
About the positions
Currently 2 Temporary positions are open to do the following tasks:
- Create and maintain records and procedures by collecting information from stakeholders to supply manufacturing with compliant documents.
- Start-up events and support investigations by giving input as procedural SME.
- Support the change process by writing SME assessment to ensure procedural alignment. Performs timely closure of action items to ensure reliable execution of production.
- Continuous improve the department processes and support stakeholder improvement projects
We are looking for persons who are responsible, conscientious and ready for professional development.
- You are able to navigate on your own, in a team and among many stakeholders.
- Educational background is preferably a Bachelor or Master within engineering, science, pharmacy or similar.
- Preferably experience with cGMP and pharmaceutical manufacturing.
- We are an international company and fluency in English is required.
If your qualifications meet our requirements, and we have sparked your interest in joining us, please upload your CV and cover letter as soon as possible. We will process the applications as the arrive. For questions please reach out to Nina Hartling +45 4194 9718.
FUJIFILM Diosynth Biotechnologies is a world leading cGMP Contract Development and Manufacturing Organisation (CDMO) with over 25 years’ experience. As a world leading CDMO we combine technical leadership in cell culture, microbial fermentation and gene therapies with state of the art GMP manufacturing, from our network of four global locations in the USA, UK and DK. We currently employ over 2,000 dedicated staff who have a reputation for excellent customer service, flexibility and responsiveness.
As part of FUJIFILM Diosynth Biotechnologies you will be an active contributor in the advancement of tomorrow’s medicine. We take pride in enriching our communities, caring for our environment and cultivating a world of opportunity for future generations. We invest in you and what you care about, getting the right work-life balance for your health, your family and your professional growth.
FUJIFILM Diosynth Biotechnologies offers a healthy work environment that promotes individual responsibility, allowing you to grow and progress. We support our employees with programs that motivate and educate, promoting a healthy work-life balance that ultimately increases personal well-being and employee satisfaction.