stillingsbetegnelse: Scientist QA Operations

jobbeskrivelse:
Join a dynamic and international company where everyone is responsible for delivering right on time as one team! Do you want to be part of a team of 9 highly dedicated QA specialists that are responsible for batch disposition? Do you want to understand the manufacturing process and be the QA on shop-floor that support one of the four manufacturing lines at CMC? Do you want to play a key role in bringing numerous pharmaceutical productions safely and efficiently to market? Then join CMC Biologics in a new QA position and become part of an international and modern organization that delivers biopharmaceutical development and manufacturing right and on time. Deliver quality assurance of biopharmaceutical products and API You will be responsible for daily QA support for the commercial manufacturing line at CMC. Work tasks includes, QA on the line, participate in daily manufacturing meetings, review batch production records, approve CRs, Deviations and CAPAs and in general facilitate continual improvement of the systems. We are preparing the Site for an FDA Pre-Approval Inspection (PAI), expected to take place in autumn this year. The QA Operations team has a key role during the FDA PAI Inspection. Develop your GMP skills and build relations with highly skilled people from the industry You will cooperate closely with manufacturing the other QA teams and departments in the organization in order to ensure that all quality related activities are carried out effectively and in compliance with cGMP. Through internal and external audits, 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. Academic QA with pharmaceutical manufacturing experience You have experiences with interpretation of global cGMP rules concerning manufacturing and quality assurance of biopharmaceutical products and API. Our Quality System is compliant to ICH Q7 and relevant parts of FDA 21 CFR part 11, 210, 211, 600 and 610. You have a relevant academic background within pharmacy, biotechnology or similar. Ideally you have QA knowledge in several of the following areas: • Commercial GMP production and/or with production for late stage clinical trials. • Production of biotechnological products and APIs. • Review of batch documentation. • Review of deviations, CAPAs and CRs. • Requirements for IQ, OQ, PQ of facility equipment. • Requirements for clean utilities. • Requirements for cleaning validation and monitoring. • Requirements clean room and environmental monitoring. • Regulatory inspections e.g. EMA, FDA and customer audits (internal and external audits). Join an international and agile organization At CMC, you will get great opportunities to work with a varied array of tasks and challenges. You will get experience with our various departments as well as exciting and challenging assignments. Furthermore, you will to a large extend be able to plan your daily work yourself. CMC offers an informal working environment, where high energy and enthusiasm 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 Operations Manager Pernille Bülow +45 2948, HR business partner Jeppe Højrup, telephone +45 2294 2942, 8409 or Vice President for Quality, Bent Hygum, telephone +45 2948 8445. To apply, please use the link below. The applications will be processed continuously, so please apply as soon as possible and no later than March 20th, 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 cli

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