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QA Scientist for Facility and Equipment

Our exiting journey continues in helping patients to a better life. AGC Biologics is expanding our current Copenhagen site with a brand new facility – an investment for approx. 160 million Euro. This expansion will more than double AGC Biologics’ single-use bioreactor mammalian cell-culture capacity in Copenhagen, enabling AGC Biologics to meet the needs of the market. The new building will have a total floor area of approximately 19,000m2 and is an important part of AGC Biologics’ global expansion plan. The facility is expected to start operating in 2023. Already now we are looking for talented colleagues to join. If you want to be part of AGC Biologics, look at the position below and see if there is a match with your expectation for a new professional challenge. The QA Facilities and Equipment team is looking for a QA scientist to assist with quality assurance of manufacturing activities, qualification of equipment and validation activities of biological API for phase I-III clinical trials and commercial manufacturing.  QA Facility and EquipmentQA Facilities and Equipment team consists of highly qualified scientists with various professional backgrounds and several years of experience within Quality Assurance. Besides the QA Facility and Equipment team, the quality unit department consist of the teams Quality Systems and QA Operation.
The main responsibility of the QA Facilities and Equipment team is to ensure that our production facility and laboratories at all times are in accordance with current standards for GMP production, i.e. EU GMP, 21 CFR and ICH guidelines. We are actively involved in the constant development within our field and the continuous improvement of our quality system and Facility.
Develop your GMP skills and build relations with highly skilled people from the industryYou will cooperate closely with the other teams in QA and departments at AGC Biologics in CPH and with colleagues from our sister sites in US, Japan and Germany in order to ensure that all quality related activities are carried out LEAN, effectively and in compliance with cGMP. Through customer projects, audits and inspections as well as continuous improvements and rebuild of the AGC Facility and processes, you are exposed to many 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. The department has an open communication with focus on a high level of professionalism. We are open-minded and have a high support level to our colleagues in the rest of AGC Biologics A/S - and not least to our international customers. The QA team is characterized by a positive and proactive environment colleagues working together in committed and friendly collaboration.  Your ProfileYou have experience with Quality Assurance of API manufacturing. It is a requirement for this position to have a relevant academic background within pharmacy, biotechnology, engineering or similar.
Ideally, you have a few years knowledge in several of the following areas:

  • Deviation handling including root cause investigations
  • CAPA and Change Control handling
  • QA approval of qualification documents for Facility, Utility and Equipment
  • QA oversight of manufacturing activities and guidance of manufacturing staff
  • Requirements for commercial and/or late state clinical phase GMP manufacturing of biological intermediates, APIs and Cell Banks
  • QA approval and provide training in SOPs
  • Experience with Contract Manufacturing


It is of utmost importance to have a self-motivating personality with a pragmatic attitude and approach to the daily work - without compromising quality. The environment is dynamic and challenging, which requires the ability to find solutions, deliver on promises and give our customers a positive experience. As QA Scientist, you will be involved in various daily operational tasks in a dynamic and challenging environment. The team handles review and approval of quality documentation e.g. qualifications of equipment, IQ, OQ, PQ related to facility equipment, Environmental Monitoring, Cleaning Validation, Deviation handling, Approval of CAPA and Change Requests
AGC has international customers and our company language is English. It is therefore a required ability that communication in both written and spoken English is fluent.
AGC offersAGC 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. ApplicationWe 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.? For further information about this position, please contact Team Leader for QA Facilities & Equipment Mette Juncker on +45 22 94 30 95. 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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