Arbejde Senior Quality Assurance Associate I (downstream) Hovedstaden BIOGEN (DENMARK) NEW MANUFACTURINGApS - jobtilbud

GÆLDER
stillingsbetegnelse: Senior Quality Assurance Associate I (downstream)

jobbeskrivelse:
About Biogen Biogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients. As a company, Biogen recognizes that cutting-edge science and medicines can change the course of devastating diseases. For more information please visit: http://www.biogen.com/careers Biogen Hillerød is currently looking for an experienced quality associate specialist to join the QA LSM Operation Downstream team. The team consists of 10 employees with whom you will work very closely, and this team forms part of the QA LSM Operations department, consisting of 18 employees with primary responsibility for review and release of Drug Substance (API). Primary Responsibilities: ? 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. ? Perform QA review and approval of Deviations and CAPAS. ? Assess and approve for execution change control requests. ? QA representative in Drug Substance Technology Transfer ? Act as primary QA Downstream contact for the manufacturing team as needed ? Be part of the disposition process of Drug Substance batches. Opportunity to become a delegated Qualified Person ? 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 Qualifications/ Skills: ? Minimum 5 years’ experience from biotech or pharmaceutical industry ? Knowledge of Good Manufacturing Practice (GMP) ? Strong English communication and writing skills Education: ? Minimum Bachelor’s degree, but ideally Master’s or PhD in Pharmacy, Chemistry, Biotechnology or similar is required

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

GÆLDER

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