Sr. Associate for Quality Assurance, Systems & Support
Contratación en HOVEDSTADEN (Dinamarca) de Analistas de gestión y organización
Clasificación del trabajo:Profesionales científicos e intelectuales : Especialistas en organización de la administración pública y de empresas : Especialistas en organización de administración : Analistas de gestión y organización. Arbejde, der forudsætter viden på højeste niveau inden for pågældende område : Arbejde, der forudsætter viden på højeste niveau inden for økonomi, administration og salg : Arbejde inden for virksomhedsadministration — privat og offentlig : Analytikerarbejde inden for ledelse og virksomhedsorganisation.
Descripción de la oferta de trabajo:
Job Description Are you a motivated and driven team-player and do you have experience working with quality systems? Then you might be the person we are looking for! We are currently looking for a Senior Associate to join Biogen’s Quality Assurance Systems & Support team based in Hillerød, Denmark. The Quality Assurance Systems & Support department consists of two teams which are characterized by working dedicated together and with counterparts across Biogen’s subsidiaries globally; the Record Lifecycle Management (RL) team and the Quality Management System (QMS) team. You’ll be part of the QMS team which currently consists of five people. Primary Responsibilities • Facilitate the document change control process from initiation through document effectivity • Review and may provide final Quality approval of Standard Operating Procedures (SOP’s), Forms, Master Production Records (MPR’s), and Solution Lot Records (SLR’s) related to Manufacturing/Packaging operations • Provide training to Site personnel on departmental SOP’s, Quality Systems documents and Qualifying Events as related to QA • Provide QA representation and guidance for manufacturing on issues related to Documentation and Compliance. • Provide technical assistance to manufacturing operations as related to compliance requirements • Lead department projects and participate in Global Documentation Quality system teams/projects and devise implementation plans • Develop, review and implement improved practices and procedural-based documents. Demonstrate ability to resolve issues with customers independently with a commitment to customer service. Revise and perform biennial review of procedural-based documents • Lead internal/self-inspection audits to assure cGMP compliance • Provide QA support and representation for documentation procedures during Regulatory inspections. *LI-DEN1 Location Hillerod, Denmark Job Category Operations, Technology & Innovation (PO&T), Quality Requisition Number 30780BR Qualifications • Minimum 5-8 years of experience in a regulated environment • Experience in working in a Quality Management System • It is a plus if you have an ASQ certification or an ISPE, PDA membership or equivalent • Fluency in English is required; ability to speak and write Danish is a plus Education • BA degree in a science, IT or a relevant business discipline About Biogen Corporate Overview Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS). Biogen also manufactures and commercializes biosimilars of advanced biologics. Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options. One of the pioneers in biotechnology, Biogen was founded in 1978 and today serves patients in nearly 90 countries. Our global headquarters and R&D operations are located in Cambridge, Massachusetts, with an international headquarters in Zug, Switzerland, world-class manufacturing facilities in Research Triangle Park, North Carolina, USA and Hillerod, Denmark, and affiliate locations around the world. Our Science We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry. To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments. For nearly
Servicio de empleo de origen:AMS, Servicios Públicos de Empleo, Dinamarca.