Arbejde QA Sr. Supervisor/Manager Hovedstaden BIOGEN (DENMARK) NEW MANUFACTURINGApS - jobtilbud

GÆLDER
stillingsbetegnelse: QA Sr. Supervisor/Manager

jobbeskrivelse:
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. Biogen is expanding and a new position is in place as Sr. Supervisor/Manager for a team of 5 delegated QP’s in Hillerød, External Quality Operation. The new QA Sr. Supervisor must have minimum 5 years of experience including experience as QP. Experience from other parts of production environment is a plus. This could be the right job/position for the ambitious specialist who wants to become Supervisor and take the next step at the carrier path. The position combines the role as QP Specialist with management of a skilled team of 5 employees. The job: You will report to the Manager, External Quality Operation. You will be Supervisor for a skilled team of 5 employees. 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. Your primary responsibility is to ensure that each lot of Finished Products has been manufactured and tested in accordance with GMP regulations and the Marketing Authorization. Furthermore keep up to date on cGMP/cGDP and regulatory requirements. You will be involved and take responsibility for relevant parts of Global Quality System, with main focus on leading process improvements of these systems etc. You will manage a team which includes planning, goal setting and management of personnel in accordance with department goals. All communication is in English. Thus it is crucial that you feel confident communicating in English. Your main responsibilities will be: •Responsible for planning and coordination of timely QA review and disposition of batch documentation. Liase with other functions within the supply chain to ensure timely supply of medicinal product. •Performs QP certification of medicinal products in compliance with the information submitted to the competent authorities. Perform Quality Assurance review and disposition of batch documentation of medicinal products. Perform the appropriate transactions and distribution of the disposition documentation following the QP batch disposition of the lot. •Participates in audits of CMOs and external audits/inspections of Biogen as required. •Close collaboration and daily contact to other Biogen departments in Switzerland and UK. •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. 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 you will get the opportunity to influence your own future through creativity and innovation. Your Professional Qualifications: •Solid experience from the biotech or pharmaceutical industry, and as a QP. •At least 5 years’ experience in manufacturing, QC and/or QA. •Strong English skills verbally and in understanding. •Thorough knowledge about EMEA and FDA regulations. Your Personal Qualifications: •You are a good role model. •You are ambitious, energetic and strive to deliver on time. •You apply theoretical knowledge in multiple areas of expertise to devise solutions. •You are able to filter information and establish priorities. •You are good at building relationships, and collaborating with colleagues globally. •You are robust and enjoy working in a busy and changing environment. •You prosper from w

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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