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Senior Associate (QA Specialist/Delegated QP)

BIOGEN (DENMARK) NEW MANUFACTURINGApS

Hillerød, Nordsjælland

Indrykket
12-01-2019
Kontakt
BIOGEN (DENMARK) NEW MANUFACTURINGApS
Biogen Idec Alle 1
3400
Hillerød
Tlf
77416999
Praktisk information
Oprettet
12-01-2019
Udløber
31-01-2019
Kviknummer
329925262
Jobtype
Fuldtid
Arbejdsområde
Administration
Stillingsbetegnelse
Kvalitetsmedarbejder
Erfaringer - I højere grad
Ikke angivet (Økonomi), Ikke angivet (Kontor og administration), Ikke angivet (Jura og retsvæsen), Ikke angivet (Human Resources), Ikke angivet (Forsvar, politi, sikkerhed), Ikke angivet (Administration)
Sprog
Dansk Læse/ tale

Senior Associate (QA Specialist/Delegated QP)

Denmark-Hillerod

Summary

Are you a self-driven and proactive team player and do you have experience with QA support for assembly and finished goods production? Then you might be the person we are looking for.

Job Category

Quality

Requisition Number

36356BR

Job Description

We are looking for an experienced packaging Specialist/Delegated QP to join the QA Material and Assembly team at Biogen in Hillerød. You will be part of a group of nine people who has the main responsibility for QA Support to Manufacturing Sciences and Assembly, Label & Pack in Hillerød. Furthermore, the job also includes collaboration with external packaging Partners.Primary Responsibilities• QA support for assembly batches for devices and commercial finished products manufactured at our site in Hillerød• Support commercial projects related to product launches, product life cycle development etc.• Close collaboration and daily contact with the Assembly, Label & Pack and support functions both in Hillerød as well as globally in Biogen in Switzerland and in US• Review of documentation, deviations, CAPA, Quality Agreements etc. related to batch disposition• Participate in compliance audits

Qualifications

• You thrive in an international, multi-cultural environment where things are constantly changing • Profound knowledge of Good Manufacturing Practice (GMP) is a requirement and knowledge within ISO 13485 is an advantage• Experience with Support on the line to Finished Goods and Assembly • Experience with Electronic Batch Documentation• Min 5 years of experience from biotech or pharmaceutical industry is preferred and especially experience within assembly processes and devices are an advantage

Education

• Master of Sciences in Pharmacy, Chemistry, Biotechnology, Engineering or equivalent is required

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BIOGEN (DENMARK) NEW MANUFACTURINGApS

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HORNE KIRKEKASSE
Virksomhedsinformation
BIOGEN (DENMARK) NEW MANUFACTURINGApS
Biogen Idec Alle 1
3400
Hillerød
Tlf
77416999
Praktisk information
Oprettet
12-01-2019
Udløber
31-01-2019
Kviknummer
329925262
Jobtype
Fuldtid
Arbejdsområde
Administration
Stillingsbetegnelse
Kvalitetsmedarbejder
Erfaringer - I højere grad
Ikke angivet (Økonomi), Ikke angivet (Kontor og administration), Ikke angivet (Jura og retsvæsen), Ikke angivet (Human Resources), Ikke angivet (Forsvar, politi, sikkerhed), Ikke angivet (Administration)
Sprog
Dansk Læse/ tale
Beliggenhed