stillingsbetegnelse:
Experienced QA/QP specialist for Supply Chain Quality. For one of the newest and most exiting pharmaceutical manufacturing sites in Denmark with an international profile

jobbeskrivelse:
Beirholm Search recruiting on behalf of Biogen Idec in Hillerød For one of the newest and most exiting pharmaceutical manufacturing sites in Denmark with a international profile. Biogen Idec discovers, develops and delivers innovative therapies for the treatment of neurodegenerative diseases, hemophilia and autoimmune disorders. Patients worldwide benefit from its leading multiple sclerosis therapies. Our new QA specialist will have at least 5 years of experience from the Pharmaceutical industry from a similar position. The department is upscaling do to take on new projects and responsibilities so this is a new position. You will welcome the challenge to work for a highly recognized company like Biogen Idec with strong focus on results achieved through dedicated work and a strong focus on common values and common targets. Your team and you will support a lot of customers in-house as well as outside and it will be your common responsibility to further develop the team spirit. The job: You will report to the Manager, Commercial Supplier Chain Quality and be part of a skilled team of 5 colleagues. This group is a part of the global Supplier Quality organization in Biogen Idec and is responsible for release of products packaged at CMOs. The department is responsible for release of some of Biogen Idec’s newest products and new launches are part of our daily work. In addition the department is now taking on an exciting new project, where the new QP will be involved. Your primary responsibility as a QP will be release and securing the quality of products packaged at CMOs for the European and International markets. You collaborate with our colleagues primarily in Switzerland, in order to ensure that quality product is delivered to the patients. You will be assigned the responsibility for one or more of the products in the department’s portfolio, and you will be responsible for staying on top of issues, change controls, deviations, complaints etc. for the product, and communicating this to your colleagues. The international work will give you the opportunity to travel – mainly in Europe. We estimate 10-20 days a year. All communication is in English. Thus it is crucial that you feel confident communicating in English. Your main responsibilities will be: •Review and release of commercial finished goods produced at contract manufacturing organizations (CMO). •Approval of change controls, deviations, CAPA’s, artwork etc. •Participate in QA activities for commercialization of clinical products. •Close collaboration and daily contact to other Biogen Idec departments in UK, US and Switzerland. •Participate in relevant 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. 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. In Biogen Idec you will get the opportunity to influence your own future through creativity and innovation. Your Professional Qualifications: •Experience from the biotech or pharmaceutical industry •Strong experience from a GMP environment •Strong English skills verbally and in understanding •Experienced user of MS Office. Knowledge of Trackwise, eDocs and Oracle would be an advantage. Your Personal Qualifications: •As a person you are working independently and take ownership of your task. •You are detail oriented and keep focus with a business perspective. •You prosper from working and communicating with your colleagues who are multicultural and sometimes with base in different countries. •Humor and team work are important elements in you work day. Your fo

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