Maternity Cover, QA Associate for Drug Substance (12 months)

Are you ready to be an important part of development and assurance of quality for the next life-saving medicine or new vaccines?

At FUJIFILM Diosynth Biotechnologies, an exciting opportunity awaits you to collaborate with some of the most innovative biopharma companies worldwide. Here you will have the chance to learn from some of the most dedicated scientists, engineers, and manufacturers who are deeply committed to making an impact on people’s lives.

About the Role and your Qualifications

We are seeking an individual with a high QA mindset in GDP practice, GMP quality systems, and legislation who holds a university degree in a scientific field such as Pharmacy, Medicine, Chemistry, Biology or similar.

Your tasks will include but not limited to following responsibilities:

• To perform batch review activities, ensuring the batch has been manufactured and tested in accordance with GMP regulations.
• To review and approve alarms from our alarm system, work orders from our maintenance system and bill of materials/parameters/ for our production needs.
• To help maintain the quality system based on the current GMP, Good Documentation Practices and regulatory requirements.
• To adhere to the quality system and support the Drug Substance Manufacturing organization in appropriate handling of exceptions and change management.
• You will also support the quality assurance department with all relevant ad hoc quality tasks.

About the Department
As a valued member of DS QA Department, you will thrive in this role if you enjoy a changing environment in collaboration with great colleagues and stakeholders engaging in activities spanning manufacturing operations and optimizing projects.

Our department is experiencing robust growth and currently consists of approximately 45 people. We put teams over hierarchy by structuring the department into Upstream-, Downstream- and QP-team where daily interactions and support foster professional and personal development across the Teams.

Application
Has this sparked your interest? Then we urge you to please upload your CV and cover letter as soon as possible as we will be doing interviews on an ongoing basis. Should you have any questions, please feel free to reach out to Lotte Risom, Manager in QA at [email protected].

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.

Location: FDBD Hillerod