Arbejde 2 experienced QA/QP specialists needed for Supply Chain Quality Hovedstaden BIOGEN (DENMARK) NEW MANUFACTURINGApS - jobtilbud

GÆLDER
stillingsbetegnelse:
2 experienced QA/QP specialists needed for Supply Chain Quality

jobbeskrivelse:
For one of the newest and most exiting pharmaceutical manufacturing sites in Denmark with an international profile Biogen 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 specialists will have at least 5 years of experience from the pharmaceutical industry from a similar position. The department is scaling up due to taking on new projects and responsibilities so this is new positions. You welcome the challenge to work for a highly recognized company like Biogen 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 Supply Chain Quality and be part of a skilled team of 7 colleagues. This group is a part of the international Quality organization in Biogen and is responsible for release of products packaged at contract manufacturers (CMO). The department is responsible for release of some of Biogen’s newest products and new launches are part of our daily work. In addition the department is now taking on new projects. We will be releasing biosimilar` s for European and International markets, in collaboration with our external partner and implementing products at both new and existing CMOs. 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 on time. 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 departments in UK and Switzerland. •Participate in relevant projects. The work place: Biogen´s European production site in Hillerød offers a dynamic working environment where more than 620 employees representing more than 18 different nationalities strive for the best results. In Biogen 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 around 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: •Experience from the biotech or pharmaceutical industry, preferably as a QP. •Fulfill the EU requirements to become a Qualified Person. •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 tasks. •You are detail oriented and keep focus with a business perspective. •You prosper from working and communicating with your colleagues who are m

Arbejdsgiver Navn: BIOGEN (DENMARK) NEW MANUFACTURINGApS

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

GÆLDER

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