stillingsbetegnelse: Quality Assurance, Downstream and Upstream

jobbeskrivelse:
Job Description Are you a QA specialist with broad experience from the biotech or pharmaceutical industry or are you recently graduated and fascinated by Quality Assurance? Then this is your chance to become part of the Quality Assurance, Large Manufacturing Scale department at Biogen in Hillerød. Biogen, the world’s oldest independent biotech companies, is a world leader in the development and manufacturing of biologics, and faces some very exciting times with impending launches of multiple products in coming years. You will be part of the QA LSM Operation Downstream or Upstream team. Both teams form part of the QA LSM Operations department, consisting of 15 employees with primary responsibility for review and release of Drug Substance (API). You will become a member of a skilled team, with whom you will work very closely and support each other in the daily work. Your main responsibilities will be: • To assess drug substance quality through review batch production records for intermediate products and drug substance (downstream), and through being on the floor during manufacturing as applicable. • Act as primary QA Downstream contact for the manufacturing team as needed • Be part of the disposition process of Drug Substance batches • You will be responsible for handling of product related exceptions in relation with the manufacturing of drug substance at the Large scale manufacturing plant in Hillerød • Perform review and approval of documentation, including master records, work instructions and standard operation procedures (SOP´s) • Perform review and release of raw material for Drug Substance manufacturing • Perform QA logbook review • Assess and approve Change Control requests • Perform review and approval of documentation, including master records, work instructions and standard operation procedures (SOP´s) • Act as subject matter expert in audits and inspections from competent authorities and external parties. • Work with Quality improvement and other quality challenges in close collaboration with mainly internal customers • Participate in ad hoc related tasks and projects JIX1 *LI-DEN2 Location Denmark-Hillerod Job Category Quality Requisition Number 24981BR Qualifications Your professional qualifications: • Experience from biotech or pharmaceutical industry is an advantage • Knowledge of Good Manufacturing Practice (GMP) is an advantage • Strong English communication and writing skills • Experience user of MS Office, Knowledge of Trackwise, eDocs and Oracle would be an advantage Your personal qualifications: • You bring sense of humor and energy to work every day, and create good working relationships with your colleagues • You thrive in an international, multi-cultural environment where things are constantly changing • You have a positive and pragmatic attitude with focus on priorities and delivery on time • You are self-driven, positive and proactive and you take ownership and responsibility for your assignments • You are a strong team player, but also capable for working independently Education Master of Sciences in Pharmacy, Chemistry, Biotechnology or similar is required For further information please contact Gema Varela, Sr. Supervisor Upstream, tel. +45 77416246 or Eva Op De Beeck, Recruiting Partner, tel. +45 77416099. Apply online. Your application and CV must be in English. 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 one of 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 with few or no tr

Arbejdsgiver Navn: BIOGEN IDEC (DENMARK) NEW MANUFACTURING ApS

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