Arbejde Senior Associate (QA Specialist/Delegated QP) unspecified BIOGEN (DENMARK) NEW MANUFACTURINGApS - jobtilbud
reference: 4916614
documentId: 4916614
connectionPointId: 7
lastModificationDate: 1544449873056
stillingsbetegnelse: Senior Associate (QA Specialist/Delegated QP)
jobbeskrivelse:
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
numberOfPosts: 1
jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2421
abstractJV_contact_0: Please apply using one of the specified channels
positionTypeCode: directhire
contractTypeCodes_0: fulltime
Arbejdsgiver Navn: BIOGEN (DENMARK) NEW MANUFACTURINGApS
source: DK-STAR
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