stillingsbetegnelse:
Compliance Coordinator/Controller for Manufacturing

jobbeskrivelse:
Join a dynamic and international company where everyone is responsible for delivering right on time as one team! Would you like to work at our multiproduct facilities in Copenhagen – and with state-of-the-art equipment and the newest technologies? And do you want to experience a dynamic working environment with a high variety of tasks where cGMP production never becomes routine? Then join CMC Biologics in a new established role as Compliance Coordinator/Controller and become part of an international and modern organization that delivers biopharmaceutical development and manufacturing. The position The position is in the Support team and the main task will be to take care of cross functional tasks to support the Manufacturing teams in relation to compliance and coordination. Main purpose of the position The role as Compliance Coordinator/Controller will include the following areas of responsibility: Facility changes -Coordinator at Manufacturing facility shut-down/upgrade/changes. -Overview over room status, gowning requirements, cleaning requirements and environmental monitoring during and after Manufacturing facility changes. Environmental monitoring (EM) and compliance -Overall Manufacturing coordinator for EM follow up. -Making Deviation Investigation Reports/CAPA in case of excursions. -Room/facility/sanitization inspections. Documents -Writing of Deviation Investigation Reports. -Update of documents (revisions, compliance updates). -Preparation of logbooks. -Archiving. Other ad-hoc tasks, e.g. related to the role -Facility Management system (system for controlling service and calibration of equipment). -Manufacturing/team training. Your profile and experience -You are an experienced technician or scientist with 2-5 years of cGMP experience within the pharmaceutical industry. -You have knowledge from production, environmental monitoring and/or quality assurance -You are able to drive changes and projects within tight timelines. You are able to work cross-functional with several departments in order to coordinate and control on-going facility changes etc. As a person, you have a positive attitude and think proactively. You are dynamic with the ability to operate and manage changes and have the ability to keep the overview and prioritize - also when you are busy. Finally, you are a goal oriented team player, a good collaborator and have good communication skills. 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 extent 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 a team. We will process the applications as they arrive. Therefore please submit your application and CV as soon as possible and no later than May 6th, 2016. For further information regarding the position, please do not hesitate to contact Manufacturing Manager, Henrik Strandberg, telephone +45 2948 8433 or email: hs (at) cmcbio.com. 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 cel

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