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 Material Management team. 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.

You will be part of the QA Material Management team which is responsible for ensuring that materials for our biopharmaceutical production are in compliance. You and your colleagues will be the QA Subject Matter Expert in disposition of materials which includes:

  • Disposition of raw materials, disposables and self-produced raw material
  • Approval of internal material specifications, and other material quality documents
  • Participation in quality optimization projects within QA Material Management
  • Handling of deviations, CAPA and change requests
  • Handling Supplier Change Notifications
  • Handling Supplier Complaints

Skills preferred:

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

You must:

  • 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
Deliver quality assurance of biopharmaceutical 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.

The applications will be processed continuously, so please apply as soon as possible.

AGC offers
AGC offers a dynamic working place with good opportunities of working with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a contract manufacturing organization interact in order to achieve success. Exciting and challenging assignments will constantly come your way, and you will to a large extend be able to plan your daily work yourself. AGC offers an informal working environment, where humor 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.

Contact
For further information regarding the position, please do not hesitate to contact Sr. Director QA Operations Lise Marie Christensen  telephone +4522943058, Marianne Domdal Østenkjær Team Lead QA Material Management telephone +4522942969 or HR business partner Niels Carlsen, telephone +45 23 34 61 56.

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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.

 

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