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GxP Auditors

Hillerød, Denmark

We are now offering jobs to exceptional individuals!

Do you want to join an advanced biotech company that develops and manufactures some of the leading biological products on the market today and for the future? Fujifilm Diosynth Biotechnologies is 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, meet many cultures and work with many different stakeholders and suppliers? Then we might have the job you are looking for! We are currently looking for two experienced auditors to join our auditor team.

About the team

You will be part of a great, expanding, hard-working and self-managed team of competent colleagues. We are a team of 10 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.

About the role

You will ensure, through your sound judgement, a risk-based approach that our vendors/suppliers live up to the relevant legislation (GxP, medical devices, etc.), through onsite and virtual audits, assessments 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 at our manufacturing site in Hillerød and spend much of the time with our vendors/suppliers and internal stakeholders.

Qualifications

We are looking for a candidate who can work independently but also be a team player when needed. It is important that you have experience with GxP audits and stakeholder management skills. A lead auditor certification or proof of lead audit experience is an advantage but not a must. Preferably you have practical experience with EU GMP, cGMP and IT audits from diverse positions within the biotech/pharmaceutical industry.

  • You have a relevant / scientific background (BSc or MSc degree within natural and life science)
  • 5+ years of experience GxP
  • Experience as an auditor
  • We expect you to be willing to travel (travel time approx. 30 %)
  • We are an international company and fluency in English is required
  • Fluency in Danish is preferred
  • Strong interpersonal skills

What we offer you

Great colleagues in a newly established team. A challenging position with an established CDMO, who is looking to grow. We will provide you with multiple challenges in order for you to grow as a professional.

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.

If you have any questions, contact Henrik Thrane, Sr. Manager, Supplier Quality Management and Audits. +45 4194 9919. So apply today and upload your CV and cover letter.

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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 manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities and technologies to manufacture advanced biologics. 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.