*Compliance Scientist, Engineering

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At AGC Biologics A/S we work with development and GMP manufacturing of APIs for both commercial products and products in all clinical phases. We are a client centric CDMO, and the partnership with our clients, working side by side with the clients, is our focus.

We are looking for a Coordinator for compliance tasks to the Support & Compliance team that provides support to our current facilities and our new facility that currently is in the final part of the construction phase.

The department and team

You will be part of the Engineering and Operations Support (EOS) department responsible for execution of technical projects including facility projects as well as operation of all utility and facility systems, maintenance and calibration across our facility. The department consists today of more than 45 employees including project managers, scientists/engineers and technicians.

You will be reporting to the Manager of the Support & Compliance team that drives all quality related tasks such as Deviations, Change Control, CAPAs, and procedures as well as our electronic maintenance systems. The team also manages various improvement and system upgrade projects and supports the technicians, project managers and engineers in the department on more complex trouble shooting activities.

The position

We want to strengthen our capabilities with you to improve our handling of customer audits and inspections and information request from customers/authorities. Furthermore, we also want to strengthen our capabilities regarding coordination when more complex documentation task are need to be handled e.g. in relation to facility shutdown and facility projects.

As a part of the team you will also have responsibilities to cooperate with your colleagues within the department and stakeholders from other departments to ensure that the right compliance level is kept. In that connection you will be handling quality documents such as Deviations, Change Controls, CAPAs and procedure updates together with your colleagues in the team. You will make yourself familiar with the related technical systems in order to be able to handle your tasks in an independent way. The tasks are related to components and issues on a range of utility, HVAC and manufacturing systems.

You will contribute to continuous improvement of our utilities, facilities and systems and ensure that the improvements are implemented in the quality system.

You will also participate in presentation of documentation at audits and inspections.

Your profile

Relevant academic background e.g. as engineering degree or equivalent from the pharmaceutical industry.

It is expected that you have a solid experience in working with GMP compliance from the pharmaceutical industry and quality related documentation in manufacturing or technical area.

You are pragmatic, flexible and at the same time focused on the goal with a personal drive to complete your task in an effective manner. You adapt quickly to new situations in a changing environment and you are open to sharing knowledge and learning with other colleagues. You have a structured approach to planning and execution of your task with a positive can-do attitude.

You are a strong communicator, you find it natural to establish new relationships and are known for your good collaboration skills. The ability to communicate clearly in written and spoken English are required.

How to apply
Send your application as soon as possible. We process the applications as we receive them.

If you need further information about the position, please feel free to contact Beata Jonach, Manager of Support and Compliance in EOS +45 22699460.

Want to keep posted about our growth and to learn more about our company?

We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !

AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.


Information og data

Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".

Arbejdsstedet er beliggende i København

Jobbet er oprettet på vores service den 14.8.2023, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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