stillingsbetegnelse: QC Equipment Supporter

jobbeskrivelse:
Join a dynamic and international company where everyone is responsible for delivering right on time as one team! The Department The responsibilities as equipment supporter are to ensure continuous compliance of the analytical equipment in the QC laboratories. This includes follow up on requalification status of equipment, and support in creating equipment documentation such as protocols and reports regarding initial qualification of equipment. Furthermore you will participate in troubleshooting and deviation handling in collaboration with the equipment owners. You will also be involved in implementation of Blue Mountain database (BMRAM) in order to monitor qualification status, which will become an important tool to keep the overview. The analytical equipment varies from refrigerators and freezers, to HPLC, TOC and qPCR. The tasks will be performed in close collaboration with different groups, in and outside the department. Tasks and Responsibilities To be successful it is important that you are detail oriented, have an analytical mindset, and are able to keep an overview, as you often will work on different projects at the same time. You thrive with a high degree of flexibility, and with your ability to adjust and prioritize, you are able to adapt to challenges and changes in close collaboration with the equipment owners and other stakeholders. Being a good team player and being able to work independently are equally important. Your Profile Our new equipment supporter: • Has in depth knowledge of analytical equipment. • Has solid experience in creating User Requirement Specifications (URS). • Has solid experience in creating qualification protocols/reports. • Has experience with EU GMP and FDA requirements. • Is skilled in creating an overview and systems. • Is fluent in English (written and verbal). Experience with software qualification is an advantage, but not a requirement. CMC offers CMC offers a dynamic working place with good opportunities of working with a varied array of QC related 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. We offer competitive terms of employment including e.g. pension scheme, health insurance, canteen, and a CMC supported employee club. If you need further information about the position please contact Marlene Asklund, Director of QC telephone +45 2294 3110. The applications will be processed continuously, so please apply as soon as possible and no later than May 8th, 2015. About CMC Biologics A/S CMC Biologics (CMC) is a global Contract Manufacturing Organization (CMO) with three biomanufacturing facilities in Europe 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. CMC 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 CMC Biologics’ innovative approach to cell line and process development. Visit http://www.cmcbiologics.com to learn why CMC Biologics is a World Leader in process development and contract manufacturing.

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