Manufacturing Supporter – Documentation - 3400

Do you have a flair for compliance and can handle many stakeholders? Are you looking for a position where you can take on responsibility? Then a job in FUJIFILM Diosynth Biotechnologies (FDB) might be something for you. We are a worldwide Contract Development and Manufacturing Organization (CDMO) with sites in the US, UK and Denmark. In Hillerød we are currently around 800 employees working with every aspect of biotech and pharmaceutical production.

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. 45 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.

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

Qualifications

We are looking for a person who is 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.
• Experience with cGMP and pharmaceutical manufacturing.
• We are an international company and fluency in English is required.

About Fujifilm

At Fujifilm we care about developing our employees! When you start working with us, you are not just starting a new job, but kick starting your career. As employee in DSM Support, you will be thoroughly trained, we will set new realistic goals so that you continue your development and so that we support Fujifilm’s production the best possible way

Your application

If your qualifications meet our requirements, and we have sparked your interest in joining us, please apply for this position as soon as possible as we will process the applications as the arrive. For questions please reach out to Nina Hartling +45 4194 9718.

Kilde: Jobnet.dk