Due to new projects and increasing activities the QA Operations team is looking for a QA Employee to assist with quality assurance of manufacturing activities and batch release of biological API for phase I-III clinical trials and commercial manufacturing. This position is especially target toward review of batch documentation on the shopfloor and therefore more of the working hours will be in the production area. This is a full-time permanent position.
QA Operations consists of highly qualified scientists with various professional backgrounds and several years of experience within Quality Assurance. Besides the QA Operations team, the quality unit department consist of the teams Quality Systems and QA Facility and Equipment. The main responsibility of the QA Operations team is quality assurance of manufacturing activities, batch release and QC documentation.
We are actively involved in the constant development within our field and the continuous improvement of our quality system. We aim at constantly ensuring that manufacturing are in compliance with current standards for GMP production, i.e. EU GMP, 21 CFR and ICH guidelines.
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 Operations team is characterized by positive and proactive colleagues meeting deadlines through committed and friendly collaboration.
Tasks and responsibilities
As QA you will be involved in various daily operational tasks in a dynamic and challenging environment. The team handles review and approval of quality documentation.
This QA position is specially target toward quality support of production in the shop floor and include e.g.
- Online batch review
- Deviation support and approval
- CAPA approval
- QA Approval of Buffers
- Approval of production rooms
You will contribute to the handling of mentioned team tasks, and a major part of the job will be on activities related to production documentation and Quality Assurance guidance of manufacturing staff. We cooperate closely with the other departments in the organization in order to ensure that all quality related activities are carried out effectively and in compliance with cGMP.
You have experience with GMP production of API and Adjuvant manufacturing. It is a requirement for this position to have a relevant academic background within pharmacy, biotechnology, biology or similar or a technical background with a solid experience with-in GMP production.
Ideally, you have experience with a number of the following areas:
- Review and evaluation of Batch Production Records
- Deviation handling including root cause investigations
- QA on-shop floor review
- QA oversight of manufacturing activities and guidance of manufacturing staff
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. 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 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.
For further information about this position, please contact Niruja Sivasubramaniam, Team Leader, on +45 22942962. Please send all applications via our career site. We will process the applications as they arrive. Therefore, please submit your application and CV as soon as possible.
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.