stillingsbetegnelse: Experienced QA for Medical devices

jobbeskrivelse:
Biogen Idec discovers, develops and delivers innovative therapies for the treatment of neurodegenerative diseases, haemophilia and autoimmune disorders. Patients worldwide benefit from its leading multiple sclerosis therapies. Biogen Idec is making patient convenience a core competency and is expanding the expertise into more advanced technologies for convenient administration of medicines. Thus we are looking for a candidate with solid knowledge on medical devices, ISO13485 and CFR 820 for the QA Commercial Disposition department to be able to support the production and the projects that are coming. We can offer an opportunity where you gain experience as a qualified person performing disposition of finished products and at the same time you will be the point of contact when medical device questions come in. The job: As the new member of the Materials and Assembly team in QA Commercial Disposition, you will have 9 highly skilled colleagues with whom you will work very closely as you support each other in the daily work. Your main working areas will be to: •Team up with our colleagues in Biogen Idec International and USA to establish sustainable processes for updates of device related documents, i.e. DMR •Work with batch release, handling of product related exceptions and investigations in relation to assembly of devices to European and International markets •Support to Manufacturing Science in relation to Medical Device implementation and assembly including QA representation at CMC meetings •Ensure Device documentation is maintained and updated in relation to regulatory requirements •Work with quality improvements and other quality challenges in close collaboration with internal and external collaborators •Close collaboration with Assembly Label & Pack, Warehouse, Engineering and Logistics Departments as well as other Biogen Idec departments located in Hillerød, Switzerland and US. •Participate in material and assembly related projects. The work place: Biogen Idec’s European production site in Hillerød offers a dynamic working environment where more than 580 employees representing more than 18 different nationalities strive for the best results. In Biogen Idec you will get the opportunity to influence your own future through creativity and innovation. The Hillerød site has a pivotal role in the supply of medicine to patients across the globe. The site hosts a large scale facility for manufacturing biologics, an assembly, label and packaging facility, an engineering & facilities organization as well as quality control and quality assurance. Your professional qualifications: •Minimum 5 years of work experience as a QA responsible for Medical devices •Solid knowledge of regulatory requirements for Medical devices (ISO13485 and CFR 820) •Experience in leading projects with several international stakeholders •Knowledge of Medical device development Your personal qualifications: •You bring your sense of humor and energy to work every day •You thrive in an international, multi-cultural environment, where things are constantly changing and late meetings can be expected. •You have a positive and pragmatic attitude with focus on delivery on time •You are self-driven, positive and proactive, and you are able to take ownership and responsibility for your assignments •You create good working relationships with your colleagues •You are a strong team player •You have good communication skills. Your formal education: •You have a Master of Science in Pharmacy, Chemistry, Biotechnology, Molecular Biology or equivalent Information and application: For further information you are welcome to contact Beirholm Search, Hanne Beirholm, tlph. 39403927 who is responsible for finding the right candidate for this position. This is a prioritized hire so please forward your application and résumé as soon as possible by using the “apply now” button

Arbejdsgiver Navn: BIOGEN IDEC (DENMARK) NEW MANUFACTURING ApS

Arbejdsgiver telefonnummer: 77416000

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark