stillingsbetegnelse: Senior Associate, Quality Assurance

jobbeskrivelse:
Job Description Biogen is currently looking for a Senior Associate for the Quality Assurance Engineering department at our Hillerød site. In this role you will be responsible for supporting our Quality Management System on review and approval of validation and engineering documents, regulatory and corporate guidance documents and any other technical documentation where QA needs to approve before implementation and upon completion. Furthermore you will advise project groups and be an active member of the groups where the quality input is needed. You will be part of the Quality Engineering team consisting of 14 professional team members, who are responsible for the compliance of the facility, utility and equipment in our Large Scale Manufacturing, Assembly Label &Pack and QC area. The working environment is open and honest, where we value teamwork and having an open dialog with our customers and each other. Your main responsibilities: • Proactive identification and resolution of both technical and compliance issues and gaps • Reviewing validation documentation and additional test of protocols and reports • Reviewing GMP documents and raw data for compliance to applicable regulatory and corporate guidance documents, such as CAPA´s, deviations, operational procedures, etc. • Facility and equipment controls and release during shutdown, construction, product changeover • Review and approval of change control documents and activities associated with change control execution • Support in development and implementation of Quality Systems • Advising and facilitating Quality initiatives The position requires a close co-operation with people at every level of the organization and from multiple functions, including engineers, Manufacturing personnel, SME’s on equipment and knowledge of production and drug product packaging and labeling. JIX1 *LI-DEN2 Location Denmark-Hillerod Job Category Quality Requisition Number 25376BR Qualifications Professional qualifications You have a Bachelor or Master in Physical or Biological Sciences combined with at least 4 years of working experience with cell culture, bioreactors and harvest. You have strong technical skills and experience of the validation of production equipment. You have a solid knowledge of production methodology involved in biopharmaceutical production. You are confident in making technical decisions and master the balance of being the preferred partner for the project groups while making sure that the item in question is compliant. Experience from working in a GMP environment is an advantage. Personal qualifications As a person you are self-driven and take ownership and responsibility for own assignments. You are detail oriented and positive minded. You value teamwork at all levels and perform work with an open-mind and ability to value input and new ideas from colleagues and peers. In addition you are able to prioritize tasks, be flexible and able to keep many activities running at a time. Education Education BA or M.Sc in Physical or Biological Sciences For further information please contact Annika Petersen, Senior Manager Quality Assurance at telephone +45 77416409 or Eva Op De Beeck, Recruiting Partner, telephone +45 7221 0860. Please apply online. Your application and CV must be in English. As applications are reviewed on a daily basis you are encouraged to submit your application as early as possible. About Biogen Biogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia. Founded in 1978, Biogen is the world’s oldest independent biotechnology company. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases wi

Arbejdsgiver Navn: BIOGEN IDEC (DENMARK) NEW MANUFACTURING ApS

Arbejdsgiver telefonnummer: 77416000

Job kort beskrivelse:
Arbejde inden for biologi, botanik, zoologi og beslægtede områder

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark