Due to new projects and increasing activities the QA Operations team is looking for an experienced QA scientist to assist with quality assurance of QC activities, QA Operations.

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 QC documentation, manufacturing activities and batch release.

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 QC and 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 Scientist you will be involved in various daily operational tasks in a dynamic and challenging environment.

Your main responsibility will be to support QC and QA in the area of analytical method validation for late stage and commercial products, which includes:

• Close collaboration with QA and QC
• Guiding in requirements for commercial production support
• Active involvement in major and critical laboratory investigations and deviations
• Review and approval of analytical method validation protocols and reports
• Change control and CAPAs

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 3+ years of experience with Quality Assurance of QC and API or Adjuvant manufacturing. It is a requirement for this position to have a relevant academic background within pharmacy, biotechnology, biology, chemistry or similar.

You have experience within the following areas:

• Proven experience from QA or QC within analytical method validation
• Requirements for commercial and/or late state clinical phase GMP manufacturing of biological intermediates, APIs and Cell Banks
• QA oversight of QC activities and guidance of staff
• Experience with contract manufacturing and business understanding
• Deviation handling including root cause investigations
• Review and evaluation of QC documentation

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 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 about this position, please contact Max Woweries, QA Manager, on +4541377923. 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. The job ad will close once we have found the right candidate.

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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.