Arbejde Senior Associate, Quality Assurance (Supplier Quality) unspecified BIOGEN (DENMARK) NEW MANUFACTURINGApS - jobtilbud
reference: 4890200
documentId: 4890200
connectionPointId: 7
lastModificationDate: 1539165484076
stillingsbetegnelse:
Senior Associate, Quality Assurance (Supplier Quality)
jobbeskrivelse:
Are you an experienced Quality Professional with experience working in a dynamic and international environment?
Job Category
Quality
Requisition Number
34854BR
Job Description
Then you might be the person we are looking for! We have an exciting new opportunity for an experienced QA Professional to join our External Quality Operations team in Hillerød.
You will act as our Delegated QP for Medicinal Products produced at the labeling and packaging contract manufacturing organizations (CMO) including batch record review and batch disposition.
Primary Responsibilities
• QA activities related to the labeling and packaging contract manufacturing organizations (CMO) which includes;
- Participate in QA activities for implementing new CMO´s
- Participate in audits and quality meetings
- Lead/participate in QA activities for commercialization of clinical products including preapproval inspection activities.
- Batch record review and batch disposition.
- Perform QA review of batch documentation in relation to Product Complaints or Investigations.
- Perform review of release and reject logbooks/register for finished goods
• Delegated QP for Medicinal Products according to the European Directive 2003/94/EC
• Delegated QA Manager for approval of CAPA’s and Deviations
All operations will be performed as per executed training curricula and under appropriate quality systems such as cGMP, Eudralex, vol 4 or 21 CFR part 820 as described by Biogen procedures
Qualifications
• 3-5 years of experience within QA, QC and/or manufacturing, preferably with some years of experience within QA
• Preferably experience as a delegated QP or QP from biotech or pharmaceutical industry
• Thorough knowledge about EU regulations
• Experience with GMP
• Fluency in spoken and written English
Education
• Master Degree in Pharmacy or similar
Employment Category
Full-Time Regular
Experience Level
Associate
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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