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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 new member to the Support & Compliance team providing support to our current facility and within the coming year to our new additional facility.
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 around 40 employees, with project managers, scientist and technicians.
The Support & Compliance team drives all quality related tasks such a deviations, technical system changes, CAPAs, and procedures as well as our electronic maintenance systems. The team also manage various improvement and system upgrade projects. The team also support the technicians, project manager and Scientist in the department related to more complex trouble shooting activities. The Support and Compliance team consists of 8-9 people.
The position
Your responsibilities are to cooperate with your colleagues within the department and stakeholders from other departments to ensure that the right compliance level is kept and support that the necessary quality activities are integrated in specific projects. In that connection you will 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 present documentation at audits and inspections.
Your time will be focused on our current facilities. However we will within the coming year be completing our new manufacturing facility and depending on distribution of tasks within the team you could also have activities related to the new facility.
Your profile
Relevant technical background as engineer or equivalent technical background from the pharmaceutical background or process industry.
It is preferable that you have knowledge about GMP and have experience within operation, maintenance or participated in projects and most of all like working with quality related documentation.
You are pragmatic, flexible and at the same time focus on the goal with a personal drive to complete your task in an effective manner.
You have a structured approach to planning and execution of your task.
Good communication skills – including the ability to communicate clearly and professionally in written and spoken English and Danish is preferred.
How to apply
Send your application as soon as possible as we process the applications as we receive them.
If you need further information about the position, please feel free to contact Jesper Sandholm Hansen, Sr. Director of EOS, Support and Compliance +45 25578027.
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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 "IT-supporter", og befinder sig i kategorien "Informationsteknologi".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 13.12.2022, men kan have været deaktiveret og genaktiveret igen.
- IT-supporter
- København
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