*Scientist for GMP Training Management in Quality Systems
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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 and training development.
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 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 and - process.
You will be in close collaboration with your training team members within our QS department and your primary responsibilities will be divided in two areas:
Site system owner of our Training System:
- Development of the overall Training System based on our Track Wise Digital Platform
- Development of data overviews in e.g.: Excel and PowerBI
- Participate in global networks about Training Management design across the AGC Global Network
Training developer:
- Development and implementation of training modules, courses etc.
- Development of training designs for e.g. On-the-Job training and Read & Understand training
- Development of eLearnings
- Close collaboration with department training coordinators
- 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
- Participation in customer audits
- Participation during authority inspections from EMA, US FDA and other international authorities
Education/Training:
- Master’s degree in Chemistry, Biochemistry, Pharmacy, and experience with teaching and learning processes or
- Master’s degree in Learning, psychology and experience from 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
- Experience with creating data overviews in Excel and PowerBI is an advantage but not a requirement
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
For further information, please contact Camilla Løvenkrands Glahn at [email protected]
For agencies, please contact our Talent Acquisition team at [email protected]
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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 "Forsker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 29.8.2022, men kan have været deaktiveret og genaktiveret igen.
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