stillingsbetegnelse: Quality Assurance Scientist

jobbeskrivelse:
The Department The QA department consists of a team of highly qualified technicians and scientists with various professional backgrounds and several years of experience within quality assurance. 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 our facility and activities are in compliance with current standards for GMP production, i.e. 21 CFR, ICH guidelines and EU GMP. 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 CMC - and not least to our international customers. Tasks and Responsibilities As QA Scientist you will be the key person for the continuous improvement of our Quality Management System going towards commercial manufacturing. You will ensure that the quality system lives up to all demands from the European GMP as well demands from FDA together with your team colleagues. You will be fully responsible for our vendor qualification. This includes risk assessment of the vendors, planning of audits and participation in (internal) audits. Furthermore you will be involved QA training of internal staff and preparation and improvement of internal procedures. 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 possess strong knowledge of and experience in the interpretation of global cGMP rules concerning manufacturing and quality assurance of biopharmaceutical products and API. It is a requirement for this position to have a relevant academic background within pharmacy, biotechnology or similar. Ideally you have experience with a number of the following areas: • Commercial GMP production and/or with production for late stage clinical trials. • Internal and external audits. Preferably certified GMP (or ISO) auditor, but this is not a requirement. • Knowledge and experience within production of biotechnological products and APIs . • Knowledge about regulatory inspections e.g. EMA, FDA and customer audits • Experience in performing internal audits • Professional proficiency in written and spoken English. CMC works with international clients and our company language is English We appreciate your ability to work independently, your solution oriented approach and that you are able to take a pragmatic decision when it is needed. CMC offers CMC 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. CMC offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. CMC’s employees have a flexible attitude and we help each other to reach deadlines together as One Team. For further information regarding the position, please do not hesitate to contact QA Director Lise Christensen, telephone +45 2294 3058 or email: lmc (at) cmcbio.com. We will process the applications as they arrive. Therefore please submit your application and CV as soon as possible and no later than August 17th, 2014.

Arbejdsgiver Navn: CMC Biologics A/S

Arbejdsgiver telefonnummer: 70209470

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark