stillingsbetegnelse: Sr. Associate I, QA LSM (1 Year Maternity Cover)

jobbeskrivelse:
Location: Hillerod, Denmark External Posting Title Sr. Associate I, QA LSM (1 Year Maternity Cover) Job Description Biogen Idec Hillerød is currently looking for an experienced quality associate specialist to join the QA LSM Operation Upstream team. The team consists of 6 employees with whom you will work very closely, and this team forms part of the QA LSM Operations department, consisting of 15 employees with primary responsibility for review and release of Drug Substance (API). Your main responsibilities will be: • To assess drug substance quality through review batch production records for intermediate products and drug substance (upstream), and through being on the floor during manufacturing as applicable. • Act as primary QA upstream contact for the manufacturing team as needed • Be part of the disposition process of Drug Substance batches • 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 For the right person this can be a springboard to a career in Biogen, where you will develop professionally as well as personally. You will work in an international and highly dynamic environment, including collaboration with international affiliates and external partners. Biogen offers a very competitive and flexible benefit package. As application are reviewed on a daily basis you are encouraged to submit your application as early as possible. For further information please contact Gema Varela, Sr. Supervisor QA at telephone +45 7741 6246. Location Hillerod, Denmark Job Category Quality Requisition Number 25333BR 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 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 or PhD in Pharmacy, Chemistry, Biotechnology or similar is required 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 with few or no treatment options. These include programs for secondary progressive MS, Alzheimer’s Disease, spinal muscular atrophy, lupus and amyotrophic lateral sclerosis (ALS), amongst others. With approximately 7,500 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries. All qualified applicants will receive consideration for emp

Arbejdsgiver Navn: BIOGEN IDEC (DENMARK) NEW MANUFACTURING ApS

Arbejdsgiver telefonnummer: 77416000

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark