*Scientist for GMP Training Management in Quality Systems Department

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We are expanding to support increasing quality activities and we are looking for a skilled Scientist with a strong interest in GMP Training Management to join our Quality Systems department. The challenging position has a broad variety of responsibility areas across the biopharmaceutical manufacturing process and quality systems. You will join a team where you will have great opportunities to influence, change and improve processes.

About Quality Systems

Quality Systems is an important part of the Quality organization. You will be joining a diverse team of highly qualified colleagues, all with several years of experience within quality assurance.

The Quality Systems team is responsible for maintenance and development of our quality systems for etc. deviation, CAPA, change management, complaints, training management, and document control. We also have oversight of the supplier qualification program, internal and external audits, regulatory inspections, and customer quality agreements.

We are also actively involved in the constant development and improvement of the quality system and our facility in Søborg.

The team works closely together with the Quality Operations team, and routinely collaborates with partners across all functional areas at the site and globally, to ensure all quality-related activities are carried out effectively, efficiently, and in compliance with cGMP. We keep an open communication with focus on a high level of professionalism. We are open-minded and committed to providing high-quality service to our colleagues in the rest of AGC Biologics and – and to our customers, as well.

The role:

You will be part of the QS department, which is responsible for managing the training system.

You will be in close collaborating with your training team members within our QS department and your primary responsibilities are:

  • Development of the overall Training System based on our TrackWise Digital Platform
  • Development and implementation of TrackWise Digital training systems for training modules, courses etc.
  • Development of cross-organizational and department specific training design for e.g. On-the-Job training and Read & Understand training
  • Collaboration with department training coordinators
  • Perform training in specific GMP areas
  • Global networking and Training Management design across the AGC Global Network
  • Participation in customer audits
  • Participation during authority inspections from EMA, US FDA and other international authorities
  • Participation in quality projects

Furthermore, the department is responsible for ensuring that our Quality System is in a state of control and based on your qualifications you will have responsibility for:

  • Supporting Quality System processes based on your competences
  • Subject Matter Expert on key SOPs related to your area of responsibility

Education/Training:

  • Master’s degree in Chemistry, Biochemistry, Pharmacy, with learning experience or
  • Master’s degree in Learning, psychology with experience in a GMP environment
  • Preferably 3+ years’ experience working in a cGMP environment Experience with Training Management and especially structure/design of training systems
  • Experience with creating eLearning’s
  • Strong presentation and communication skills
  • +3 years’ experience from the Biopharmaceutical Industry
  • Experiences with interpretation of global cGMP rules concerning manufacturing and quality assurance of biopharmaceutical products and API

Soft skills and competencies:

  • Have flair for GMP Training Systems and IT Systems
  • Be a team player and ready to learn new things
  • Take responsibility for own tasks
  • Result oriented and able to work towards deadlines
  • Have high service level for both internal and external customers
  • Have good communication and empathy skills
  • Be flexible and pragmatic
  • Be structured and systematic
  • Be positive and open minded

#JobsForUkraine.

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 7.4.2022, 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.
  • Forsker
  • København
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