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Senior Associate, QA (Supplier Quality), Delegated QP

Are you an experienced Quality Professional with experience working in a dynamic and international environment?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.

Job Category

Quality

Requisition Number

33728BR

Job Description

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 DeviationsAll 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

• 5-7 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


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329794288Phoenix-f71130da12018-04-16T00:00:00Senior Associate, QA (Supplier Quality), Delegated QP

Are you an experienced Quality Professional with experience working in a dynamic and international environment?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.

Job Category

Quality

Requisition Number

33728BR

Job Description

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 DeviationsAll 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

• 5-7 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

2018-06-12T00:50:44.640 Are you an experienced Quality Professional with experience working in a dynamic and international environment?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. Job Category Quality Requisition Number 33728BR Job Description 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 DeviationsAll 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 • 5-7 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 Associate11Jobnetf71130da100000000000IDK_OFIR_02DKDanmark228DKK2018-06-11T00:00:000000https://sjobs.brassring.com/TGnewUI/Search/home/HomeWithPreLoad?PageType=JobDetails&noback=0&partnerid=169&siteid=5140&jobid=8022520EuropaDanmarkEuropaDanmarkSjælland & øerStorkøbenhavnAllerødEuropaDanmarkSjælland & øerNordsjællandFredensborgEuropaDanmarkSjælland & øerNordsjællandHillerød3217729BIOGEN (DENMARK) NEW MANUFACTURINGApS11Biogen Alle 13400Hillerød77416999DKDanmark0
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8Fuldtid46Permanent555377JobNet48097041000https://dispatcher.ofir.dk/statistic/register?context=FeedEntrySearchedCount&feedId=dc2beb84&entryId=f71130dahttps://dispatcher.ofir.dk/statistic/register?context=FeedEntryDisplayCount&feedId=dc2beb84&entryId=f71130dahttps://dispatcher.ofir.dk/statistic/register?context=JobApplicationInitiatedCount&feedId=dc2beb84&entryId=f71130da&page=ShowJob&component=SendApplicationButtonhttps://dispatcher.ofir.dk/statistic/register?context=JobApplicationAppliedCount&feedId=dc2beb84&entryId=f71130da&page=EmailApplyForm&component=SendApplicationButtonhttps://static.matchwork.com/company/logo/DK/ORS/SoMe/Oevrige/1.jpgSom Kvalitetsmedarbejder hos BIOGEN (DENMARK) NEW MANUFACTURINGApS bliver du en del af et godt arbejdsmiljø og bliver dagligt mødt af nye spændende udfordringer.12007991Dansk3Læse/ tale315218Kvalitetsmedarbejder0Øvrige354428499Novozymesjom@workindenmark.dkDKDanmarkDKDanmarkda-DK