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GMP Supporter in QC

About the job

We are further expanding our QC Lab Support team and are looking for a colleague with experience as GMP supporter in QC, preferably with knowledge on data integrity as well as instrument qualification and software validation or similar technical experience. You will also be working with change controls, deviations, lab exceptions and procedure updates as well as have customer related tasks, so these should also be on your list of experience.

If the above sounds familiar and fun and you are looking to make a difference in a dynamic team, this might be something for you.

We will need a colleague who brings years of GMP experience. Who knows how to ensure a high compliance level in deviations, lab exceptions, changes controls and documentation. Who can provide sparring to our QC Instruments team to ensure we utilize a risk-based approach and improve the processes. Who can support the business in identifying data integrity gaps. Who can identify improvement opportunities, shape solutions and drive these to implementation.

Someone who is able to handle a busy environment with many changing priorities without losing your good mood. A colleague with strong coordination and communication competencies and who understand and appreciates cultural differences. Someone who possess excellent collaboration skills which makes you popular with your stakeholders. Who takes pride in providing high quality, great service and in delivering on time. And who appreciates a team where there is room for technical discussions as well as a laugh.

About the department

In QC at FUJIFILM Diosynth Biotechnologies (FDB) we are approximately 90 people supporting manufacturing both on site and as a CLO. We test drug substance, drug product, all the raw materials used in the onsite manufacturing processes as well as stability samples. We have a number of testing teams and five supporting teams in QC, Lab Support is one of them.

 

The core tasks in QC Lab Support evolves around GMP compliance and includes a number of challenging and fun tasks such as; managing QC change controls for both internal changes and changes coming from our customers, driving QC investigations and CAPA´s and management of the contract laboratories (CLO´s) we use for drug substance, drug product and raw material testing. Furthermore we provide GMP support to the rest of the QC organisation with sparring on many differnt topics and ensuring compliant and well thought through solutions are implemented.

We are also responsible for forecasting and planning of QC testing and release activities, data entry approval, quality data generation for metrics and review meetings, management of controls and reference standards and ownership of specifications. Furthermore, we have some customer contact responsibilities and we deliver support for internal audits and inspections.

We are looking for a new colleague who can be part of our team, and in this particular role have special focus on the change control, investigation and documentation part as well as expand our support related to instrument qualification, software validation and data integrity.

About the position

 

  • Drive and coordinate QC change controls for both internal and external changes together with relevant stakeholders, incl. communication with customers as applicable
  • Serve as sparring partner for the QC Instruments team on technical matters related to instrument qualifications, software validations and ad-hoc tasks
  • Support the business with data integrity knowledge, identify gaps and implement solutions
  • Facilitate QC deviations together with relevant subject matter experts inside and outside QC
  • Create and maintain GMP documents in collaboration with stakeholders and QA
  • Identify optimization potential and drive implementation of improved processes including document updates and other relevant tasks
  • Initiate deviations and support investigations as applicable
  • An element of new tasks that will follow our site expansion the next years 

Qualifications and Education

  • You have several years of experience with cGMP and pharmaceutical manufacturing
  • You have instrument qualification, software validation or similar technical experience
  • You are highly experienced in handling GMP deviations, change controls and documentation
  • You have experience with Data Integrity related to QC instruments
  • You might have experience working as an CMO/CDMO or with CLO management
  • You have an academic degree or other similar education
  • On a personal level you are self-driven and dedicated, systematic and able to improve processes while working with the current systems
  • You are flexible and open for changes and interested in developing yourself into new business areas within the team
  • Almost all tasks require buy-in from stakeholders so you possess excellent communication and collaboration skills
  • You might have experience with QC data systems such as LIMS and SmartQC or metrics tools such as Tableau
  • Fluency in English is required as we are an international company

At FUJIFILM Diosynth Biotechnologies we care about developing our employees so when you start working with us, you are not just starting a new job, but kick starting your career. As employee in QC Lab Support we provide you with a variety of development options in a busy and changing environment. 

Your application

If you find the job interesting and it fits your qualifications, please upload your CV and cover letter as soon as possible as we will process the applications as they arrive. For questions please reach out to QC Supporting Teams Manager Henriette Hørbov +45 7741 6542.

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We offer

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.

 

Working at FUJIFILM Diosynth Biotechnologies

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.

 

 


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