Scientist for Material Management in Quality Assurance

  • Job reference
    4252659286

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

Tasks & Responsibilities

You will be part of the QA team which is responsible for ensuring that raw materials and items for our biopharmaceutical production are in compliance. You and your colleagues will be the QA Subject Matter Expert on approval and release of materials which includes: 

  • Approval of deviations, CAPA and change requests 
  • Approval of specifications 
  • Responsible for quality aspects in relation to suppliers 
  • Participation in customer audits 
  • Participation during authority inspections from EMA, US FDA and other international authorities  
  • Participation in quality projects 

Skills needed 

  • QA Scientist or similar relevant experience 
  • Experience with QA release of materials
  • Experiences with interpretation of global cGMP rules concerning manufacturing and quality assurance of biopharmaceutical products and API 
  • Experience from the Biopharmaceutical Industry 


Your profile 

  • Have flair for IT Quality 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 

Uddannelsesniveau
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Deliver quality assurance of bio-pharmaceutical products and API

As QA Scientist 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.  

Sprog
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Join an international and agile organization

At AGC, you will get great opportunities to work with a varied array of tasks and challenges. You will get experience with our various departments as well as exciting and challenging assignments, Furthermore, you will to a large extend be able to plan your daily work yourself. AGC offers an informal working environment, where high energy and enthusiasm is part of the daily work life. We respect each other and our individual differences. AGC’s employees have a flexible attitude and we help each other to reach deadlines together as one Team. 

 

 

How to apply
Interested? Upload CV, motivation letter, references and criminal record via the link on this page, and do it as soon as possible. AGC Biologiscs is partnering with Adecco on this recruitment, so if you have any questions about the position, you can contact our recruitment team: 

Tasja Sejerup, mobile +45 3838 1135
Lotus Mølgaard, mobile +45 3838 1124

 

 

About AGC Biologics 
AGC Biologics (AGC) is a global Contract Manufacturing Organization (CMO) with biomanufacturing facilities in Europe, Japan 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.  

AGC Biologics also offers non-exclusive license to CHEF1™, a proprietary CHO cell line development platform. CHEF1 delivers stable, high-titer, production-quality cell lines in optimized time frames. It is the foundation of AGC Biologics’ innovative approach to cell line and process development.  

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


Andre oplysninger
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Om AGC Biologics

Kontaktoplysninger
Adecco Recruitment
+45 3838 1124 / +45 3838 1135