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Quality Assurance Scientist for QA Facility

Adecco A/S



  • Job reference 4258362418

The QA Facility 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
QA Facility and Equipment consists of highly qualified scientists with various professional backgrounds and several years of experience within Quality Assurance. Besides the QA Facility team, the quality unit department consist of the teams Quality Systems and QA Operation.

The main responsibility of the QA Facility 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. You 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 of the 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.

Tasks and Responsibilities
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 Change Requests.

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.

Your Profile
You 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 experience with a number of the following areas:

  • Qualification of facilities and equipment.
  • Cleaning Validation
  • Experience with manufacturing equipment related to manufacturing of biological intermediates and API.
  • Environmental Monitoring including water and Utilities.
  • Deviation handling including root cause investigations.
  • QA oversight of manufacturing activities and guidance of manufacturing staff.

Requirements for commercial and/or late state clinical phase GMP manufacturing of biological intermediates and API.
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
AGC Biologics offers a dynamic working place and an excellent opportunity for working and growing with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a biologics contract development and manufacturing organization interact in order to achieve success. Exciting and challenging assignments will keep coming your way, but you will largely be able to plan your daily work on your own. AGC Biologics offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC employees have a flexible attitude and we help each other to reach deadlines together as one team, in accordance with our slogan - Right. On Time.

How to apply
Interested? Apply with CV, Motivation, 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 +45 3838 1135
Lotus Mølgaard +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.

Om AGC Biologics

Kontaktoplysninger
Recruitment Team

+45 3838 1135 / +45 3838 1124

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Åboulevarden 70. 2.
8000 Århus
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