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QA Technician for GMP Training Management in QA Systems

We are expanding to support increasing quality activities and we are looking for a skilled QA Specialist with a strong interest in GMP Training Management to join our QA 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. 

You will be part of the QA Systems department which is responsible for managing the GMP training system. Furthermore, the department is also responsible for the TrackWise Digital Quality IT-systems for document handling, quality processes, supplier management, internal audits, customer audits and inspections from authorities. This role will together with ten highly dedicated quality team members be the backbone the Quality Management System.

You will be in close collaborating with your 3 training QA team members within our QA Systems department and your primary responsibilities are:

  • Development of the overall GMP 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 

Skills needed:

  • ?QA Specialist or other relevant experience
  • Experience with GMP Training Management and especially structure/design of training systems
  • Experience with conducting GMP training
  • Strong presentation and communication skills
  • A few years’ experience from the Biopharmaceutical Industry
  • Experiences with interpretation of global cGMP rules concerning manufacturing and quality assurance of biopharmaceutical products and API

You must: 

  • Have flair for GMP Training Systems and IT Systems
  • Have interest in being a trainer and train others in GMP
  • 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

Deliver quality assurance of biopharmaceutical products and API
As QA Technician you will play a key role in bringing numerous pharmaceutical productions safely, efficiently and compliant to market. You will become part of an international and modern organization that delivers biopharmaceutical development and manufacturing right and on time. 

You will cooperate closely with the other teams in QA and departments in the organization in order to ensure that all quality related activities are carried out effectively and in compliance with cGMP. Through internal and external audits, you are exposed to different ways of working with GMP and pharmaceutical manufacturing, and you can expect to build great expertise within these areas by interacting with our many different international customers.

Our Quality System is compliant to ICH Q7 and US FDA 21 CFR part 11, 210, 211, 600 and 610. 

Application

We continuously evaluate incoming applications and conduct interviews accordingly. Therefore, please submit your application and CV as soon as possible. When the right candidates are found, the ad will close.

 

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.


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