stillingsbetegnelse: Compliance Specialist to Manufacturing Support

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. Are you interested in Compliance and would you like to be part of a dynamic and competent team in Biogen, the world´s oldest independent biotech company. We are looking for an Associate to join the Manufacturing Compliance team for Assembly, Label & Pack (AL&P) at the Hillerød site. The job: As a specialist you will be part of a dynamic team of 10 ambitious colleagues. You will refer to the Compliance Manager for Assembly, Label & Pack. In this role you will mainly be responsible for the compliance support for assembly line, but also provide support to AL&P in compliance and GMP related matters. You will initiate and investigate deviations and establish and implement comprehensive corrective and preventive actions to prevent reoccurrence and improve compliance. You will ensure compliance of GMP documents and participate in optimization projects. Areas of Responsibilities: Execute deviations and CAPAs • Initiate and investigate deviations and establish comprehensive corrective and preventive actions (CAPA) to prevent reoccurrence and improve compliance •Ensure on-time closure of deviations and CAPAs in accordance with defined timelines •Prioritize tasks to support defined release targets Maintain compliance of GMP documents (procedures, batch records, forms) • Review GMP documents for accuracy •Perform s to GMP documents and create new GMP documents when required •Support periodic review of GMP document Support AL&P • Provide support to daily production in compliance and GMP related matters • Participate in problem solving, occasionally across departments Support optimization projects • Be a part of optimization projects in AL&P •Support implementation of simplified processes •Collaborate with QA to ensure alignment on interpretation of GMP issues. 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: • Thorough experience and knowledge of GMP and GMP regulation. •Experience from -and Technical understanding from areas as: assembly, labelling and packaging. • You understand and are able to execute against regulatory requirements. • Experience from the Biotech or Pharmaceutical industry working in a GMP environment will be an advantage. • Strong English skills verbally, written and in understanding Your Personal Qualifications: • You are energetic and like to deliver on time and are able to work with tight deadline. • You are analytical and work in a structured manner and have a good sense of prioritization between tasks. • You enjoy working independently. • You possess good communication skills and are able to interact with stakeholders from different areas. • Humor and team work are important elements in your working day. Your formal Education: You could have a Master´s degree in Pharmacy, Engineering or similar or a Technical Degree Kontakt Ansvarlig: Hanne Beirholm tel. 39403927

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