QA Specialist for Facility and Equipment

  • Job reference
    4255377508

The QA Facility and Equipment team is looking for a QA Specialist 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 Equipment 

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 and Equipment team, the quality unit department consist of the teams Quality Systems and QA Operation.
The main responsibility of the QA Facility 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.
You will cooperate closely with the other teams in QA and departments at AGC Biologics in Copenhagen 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 a lot of 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 Specialist 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:

  • Review and evaluation of Batch Production Records.
  • 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, APIs and Cell Banks.
  • Cell bank production and storage
  • 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.

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.

 

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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.

Submit your CV, application, references and criminal as soon as possible. We treat the applications as we receive them, and conduct interviews with qualified candidates. When the right candidates are found, the add will close.

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
 
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
Tasja Sejerup

+45 3838 1135