GxP Auditor

Do you want to join an advanced biotech company that develop and manufacture some of the leading biological products on the market today and for the future? Then join Fujifilm Diosynth Biotechnologies, a biotech company that aspires to be the leading CDMO within our areas of expertise.

Do you like to feel the rumble of an airplane, to be on the road and work with many different suppliers. Then we might have the job you are looking for! We are currently looking for an experienced auditor to join our auditor team.

The team for you to join

You will be part of a great, hard-working and self-managed team of competent colleagues. We are a team of 5 experienced individuals covering a variety of tasks, we are driven by our curiosity, humor and commitment to the patient. We support each other and help where we can.

What would your role look like?

You will ensure, through your sound judgement that our vendors/ suppliers live up to the relevant legislation (GxP, medical devices, etc.), through onsite audits and questionnaires. Some audits and questionnaires will be performed with colleagues who need to be trained auditors or other experts who you will learn from. Further you will perform both internal audits and external audits. You will be based in Hillerød and spend much of the time with our vendors/ suppliers.

Who are we looking for?

A person with a good sense of humor and charm, who can work independent yet be a team player when it is needed. Strong experience with GxP audits and stakeholder skills. Lead auditor certification or proof of lead audit experience. Preferably you have practical experience with EU GMP, cGMP and IT audits from diverse positions within the biotech/ pharmaceutical industry.

You must have/ be:

  • BSc/ MSc degree within natural & life science
  • 5-10 years of experience GxP
  • Experience as lead auditor
  • Willing to travel to various countries

Travel time approximately 40-50%.

What we offer you

Great colleagues in a newly established team. A challenging position with an established CDMO, who is looking to grow. All the challenges you can ask imagine that will help you grow.

If you need more information

Contact person Kristian Byrialsen, Head of Regulatory Affairs, Supplier Quality Management and Audits. +45 26 24 33 46.

Application

Deadline for applications is 20th March 2020, applications will be reviewed continuously and relevant applicants will be interviewed continuously. So apply today and upload your CV and cover letter.

Apply

FUJIFILM Diosynth Biotechnologies is an industry-leading biologics Contract Development and Manufacturing Organization (CDMO) with locations in Teesside, UK, RTP, North Carolina, College Station, Texas and Hillerod, Denmark. FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems.

The Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities and technologies to manufacture advanced biologics. Our large scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. The facility for medical device assembly, labeling and packaging manufactures advanced delivery systems and ensures required labeling and secure packaging of the therapies for patients worldwide.

The site also houses quality control laboratories, warehouses, and a number of organizations, supporting the manufacturing activities: process science, supply chain management, engineering and quality assurance.

Our people are what make FUJIFILM Diosynth Biotechnologies standout. We recruit talented and passionate people, each playing a vital role in our success. At FUJIFILM Diosynth Biotechnologies, you will gain hands-on experience in an industry-leading biologics contract development and manufacturing organization. You will work with highly-skilled and experienced professionals of different nationalities and backgrounds, engaging in challenging work by delivering solutions for the bio-pharmaceutical industry.

We aim to foster a collaborative, innovative, diverse and rewarding environment, where it is possible to develop and learn. We pursue our fullest potential as individual contributors and team members. As part of our team, every one is a valuable 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.