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stillingsbetegnelse: Quality Assurance Scientist/QP for QA Operations

jobbeskrivelse:

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply. Right. On time. For more information, visit www.agcbio.com.

Quality Assurance Scientist/QP for QA Operations

The QA Operations team is expanding and is looking for a QA scientist to assist with quality assurance of manufacturing activities and batch release of biological API for phase I-III clinical trials and commercial manufacturing.

QA Operations
QA Operations consists of highly qualified technicians and 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 and QC activities 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 service 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. The team handles review and approval of quality documentation e.g. QC documentation, Batch Production Records, Master Production Records, specifications, analytical procedures, stability documentation, validation processes (manufacturing process and analytical method validations), change requests, deviations and CAPAs. 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. You will also be QP and release APIs.

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
Preferably 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, biology or similar. 

Ideally you have experience with a number of the following areas:
• Experience with QP release of batches
• Minimum 5 years of work experience in the pharmaceutical industry
• Review and evaluation of Master and 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.
• 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.

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 Director for QA Operations Lisbeth Voetmann on +45 41 37 79 32.

We will process the applications as they arrive. Therefore please submit your application and CV as soon as possible and no later than August 8th, 2019.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2421

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: AGC Biologics A/S

source: DK-STAR