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Quality Specialist

Job Description

We are looking for an experienced Quality Specialist 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 implementation of Electronic Batch Documentation or QA requirements for IT systems.• 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

Employment Category: Full-Time Regular

Experience Level: Associate


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329942280Phoenix-ba244add12019-02-20T00:00:00Quality Specialist

Job Description

We are looking for an experienced Quality Specialist 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 implementation of Electronic Batch Documentation or QA requirements for IT systems.• 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

Employment Category: Full-Time Regular

Experience Level: Associate

2019-03-13T14:53:18.613 Job Description We are looking for an experienced Quality Specialist 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 implementation of Electronic Batch Documentation or QA requirements for IT systems.• 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 Employment Category: Full-Time Regular Experience Level: Associate11Jobnetba244add100000000000IDK_OFIR_02DKDanmark228DKK2019-03-15T00:00:000000https://bit.ly/2QKtgcA0EuropaDanmarkSjælland & øerStorkøbenhavnAllerødEuropaDanmarkSjælland & øerNordsjællandFredensborgEuropaDanmarkSjælland & øerNordsjællandHillerød3435285BIOGEN (DENMARK) NEW MANUFACTURINGApS11Biogen Idec Alle 13400HillerødDKDanmark0DKDanmarkDKDanmark8Fuldtid46Permanent693871JobNet493027149302711000https://dispatcher.ofir.dk/statistic/register?context=FeedEntrySearchedCount&feedId=dc2beb84&entryId=ba244addhttps://dispatcher.ofir.dk/statistic/register?context=FeedEntryDisplayCount&feedId=dc2beb84&entryId=ba244addhttps://dispatcher.ofir.dk/statistic/register?context=JobApplicationInitiatedCount&feedId=dc2beb84&entryId=ba244add&page=ShowJob&component=SendApplicationButtonhttps://dispatcher.ofir.dk/statistic/register?context=JobApplicationAppliedCount&feedId=dc2beb84&entryId=ba244add&page=EmailApplyForm&component=SendApplicationButtonhttps://static.matchwork.com/company/logo/DK/ORS/SoMe/Oevrige/1.jpgEr Øvrige noget for dig? Søg jobbet som Kvalitetsmedarbejder i dag.12007991Dansk3Læse/ tale315218Kvalitetsmedarbejder0Øvrige360114094Biogennoreply@ofir.comDKDanmarkDKDanmark330073577Environmental Chemist for high-tech production facilityRobot Are you passionate about working with Environmental Monitoring (EM) and helping to define how we ensure the right environment in our production facilities? Would you like to improve how we support and conduct monitoring and reporting activities as well as the Performance Qualification of our classified areas? Then this might be your next job. About the department At Biopharm NHAPI Facility Projects, we support two high-tech production facilities that produce quality products for the treatment of hemophilia. The department is responsible for production equipment, IT automation, maintenance, calibration, and the internal production environment. We are organized in teams with daily cooperation closely across departments, teams and professional groups. You will be part of the environmental team consisting of 10 talented and dedicated employees 7 environmental chemists and 3 sample takers. The team is responsible for ensuring that the environment is top-notch and that we comply with regulatory requirements, including requirements in internal procedures. Professionalism is key, and we work with a strong can-do attitude in relation to solving our challenges. The position Your primary area of ??responsibility will be to ensure that our classified areas meet the regulatory requirements. This entails the responsibility for production clothing as well as cleaning of the facilities to comply with the current requirements, and the processing and reporting of environmental monitoring results. You will be in charge of data processing in the PEMS and globalLIMS systems, deviation management, HVAC qualification and the final reporting thereof. These activities are essential in connection with status assignment of the API produced. You will be working in a busy but socially relaxed and informal environment, where we emphasize collaboration, optimism, engagement, well-being, humour, commitment, and compliance. We offer you an exciting job in an open and dynamic work environment with good opportunities for professional and personal development. Qualifications You hold an academic degree in natural science and have 2-3 years of experience from the pharmaceutical industry or related industry. You have experience with Environmental Monitoring (EM), including HVAC and cleaning of classified areas. You have knowledge of GMP and experience with documentation according to specific guidelines. You have experience in dealing with deviations and change requests. As a person, you have an analytical approach to your tasks. You familiarize yourself with the topics and tasks and assess what the best solution is. You thrive with routine tasks, work systematically with here and now problem solving, but you also possess the ability and interest in working with improvements and execution of these. Thus, it is important that you are good at planning and working in a structured manner. Experience with LEAN, or other experience with simplification tools is an advantage. We expect you to be optimistic by nature and possess an independent drive and initiative to solve relevant tasks that are not necessarily formally delegated to you. We work as a team towards the same goal and therefore it is important that you are able to collaborate with your closest colleagues as well as across the organization. Working at Novo Nordisk At Novo Nordisk you will be met with confidence, exciting challenges and great opportunities for personal and professional development. You will get the opportunity to put your unique skills into play in an environment where sparring and knowledge sharing is paramount, and where your knowledge and experience are valuable. We are proud to use our dedication and our ability to make a difference to millions of people with chronic disorders. Contact If you would like to know more about the position, please contact Line Maria Irlund Pedersen at 3079 2624. Deadline 31 August 2019 You are welcome to submit your application in Danish or English. Qualified candidates may be interviewed before deadline. Millions rely on us To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.

Are you passionate about working with Environmental Monitoring (EM) and helping to define how we ensure the right environment in our production facilities? Would you like to improve how we support and conduct monitoring and reporting activities as well as the Performance Qualification of our classified areas? Then this might be your next job.

 

About the department

At Biopharm NHAPI Facility & Projects, we support two high-tech production facilities that produce quality products for the treatment of hemophilia. The department is responsible for production equipment, IT / automation, maintenance, calibration, and the internal production environment. We are organized in teams with daily cooperation closely across departments, teams and professional groups.

You will be part of the environmental team consisting of 10 talented and dedicated employees; 7 environmental chemists and 3 sample takers. The team is responsible for ensuring that the environment is top-notch and that we comply with regulatory requirements, including requirements in internal procedures. Professionalism is key, and we work with a strong can-do attitude in relation to solving our challenges.

 

The position

Your primary area of ??responsibility will be to ensure that our classified areas meet the regulatory requirements. This entails the responsibility for production clothing as well as cleaning of the facilities to comply with the current requirements, and the processing and reporting of environmental monitoring results. You will be in charge of data processing in the PEMS and globalLIMS systems, deviation management, HVAC qualification and the final reporting thereof. These activities are essential in connection with status assignment of the API produced.

You will be working in a busy but socially relaxed and informal environment, where we emphasize collaboration, optimism, engagement, well-being, humour, commitment, and compliance. We offer you an exciting job in an open and dynamic work environment with good opportunities for professional and personal development.

 

Qualifications

  • You hold an academic degree in natural science and have 2-3 years of experience from the pharmaceutical industry or related industry.
  • You have experience with Environmental Monitoring (EM), including HVAC and cleaning of classified areas.
  • You have knowledge of GMP and experience with documentation according to specific guidelines.
  • You have experience in dealing with deviations and change requests.

 

As a person, you have an analytical approach to your tasks. You familiarize yourself with the topics and tasks and assess what the best solution is. You thrive with routine tasks, work systematically with here and now problem solving, but you also possess the ability and interest in working with improvements and execution of these. Thus, it is important that you are good at planning and working in a structured manner. Experience with LEAN, or other experience with simplification tools is an advantage.

We expect you to be optimistic by nature and possess an independent drive and initiative to solve relevant tasks that are not necessarily formally delegated to you. We work as a team towards the same goal and therefore it is important that you are able to collaborate with your closest colleagues as well as across the organization.

 

Working at Novo Nordisk 

At Novo Nordisk you will be met with confidence, exciting challenges and great opportunities for personal and professional development. You will get the opportunity to put your unique skills into play in an environment where sparring and knowledge sharing is paramount, and where your knowledge and experience are valuable. We are proud to use our dedication and our ability to make a difference to millions of people with chronic disorders.

 

Contact

If you would like to know more about the position, please contact Line Maria Irlund Pedersen at 3079 2624.

 

Deadline

31 August 2019

You are welcome to submit your application in Danish or English. Qualified candidates may be interviewed before deadline.

 

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.

Novo Nordisk A/SHillerød2019-08-15T00:00:002019-08-31T00:00:00
330077559Akademisk medarbejder til DANAKRobot Har du lyst til at arbejde med bedømmelse af akkrediterede laboratorier inden for kalibrering samt fysisk, mekanisk og elektrisk prøvning, og være med til at lægge grundlaget for national og international anerkendelse af laboratorier så er du måske vores nye medarbejder. Som ledende assessor hos DANAK får du en uddannelse, der vil lære dig om de metoder vi bruger til bedømmelse af laboratorier og sikre dig forståelse for de akkrediteringsstandarder, som laboratorierne arbejder i henhold til. I uddannelsesforløbet vil du først være observatør på et antal bedømmelser, hvorefter du under supervision selv skal varetage bedømmelse af et antal laboratorier før du godkendes som ledende assessor. Bedømmelsesarbejdet omfatter udvælgelse og ledelse af et bedømmelseshold, som udover dig består af et antal eksperter (tekniske assessorer), oftest 1-2 men i visse tilfælde op til 4-8 eksperter. Du skal desuden koordinere og planlægge bedømmelsen og varetage afrapporteringen og den opfølgning, som ligger til grund for, at et laboratorium kan akkrediteres. Udover bedømmelse af laboratorier vil du kunne blive inddraget i drift af infrastrukturen i DANAK, som bl.a. omfatter betjening af sektorudvalg, kontakt til myndigheder, deltagelse i internationale arbejdsgrupper og komiteer, afvikling af kurser for de akkrediterede laboratorier samt regelmæssige møder med de tekniske assessorer. Vi kan tilbyde spændende og afvekslende arbejdsopgaver i et dynamisk miljø, med gode kollegaer og en uformel omgangstone. Du kommer til at arbejde i laboratoriesektionen både på vores kontor i Skovlunde og hos de akkrediterede laboratorier i hele landet. Da der er en vis rejseaktivitet knyttet til arbejdet med lange arbejdsdage til følge, vil du have flekstid og gode muligheder for fleksibilitet i at planlægge dit arbejde. Om osDANAK (Den danske Akkrediteringsfond) er en selvstændig og uafhængig fond, og er Danmarks nationale akkrediteringsorgan, som foretager akkreditering af danske virksomheder. DANAKs mission er at sikre troværdig dokumentation for overholdelse af kravspecifikationer gennem akkreditering. Det gør vi ved at akkreditere laboratorier, certificerings- og inspektionsorganer mv. til at kalibrere, måle, certificere og foretage inspektioner efter internationale standarder. Vi har et tæt samarbejde med myndigheder i Danmark og akkrediteringsorganer i andre lande. DANAK har 30 fastansatte medarbejdere, hvoraf 23 er ledende assessorer, samt 130 eksperter tilknyttet. DANAK har akkrediteret ca. 200 laboratorier, 40 certificeringsorganer og 50 inspektionsorganer. Om digVi forestiller os, at du er akademiker eller tilsvarende med en relevant naturvidenskabelig uddannelse f. eks. som maskin-, bygnings- eller elektroingeniør og med minimum fem års erhvervserfaring. Det er en fordel, hvis du har erfaring fra et eller flere af følgende områder: Kalibrering, måleteknik og estimering af måleusikkerhed Laboratoriearbejde Kvalitetssikring (f. eks. inden for ISO standarder og eller andet) Auditor (intern eller ekstern) Undervisning f. eks. afholdelse af kurser Myndighedsarbejde I jobbet er der brug for at du har gode kommunikationsevner - både skriftligt og mundtligt på dansk og engelsk. Desuden forventer vi, at du har en positiv tilgang til vores kunder og overskud til at klare en til tider meget travl arbejdsdag. Om vilkårene Vi har 37 timers arbejdsuge inklusiv frokost, flekstidsordning og flere personalegoder f. eks. sundhedsforsikring og massageordning. Da rejseaktivitet er en del af jobbet, indgår dette som en del af arbejdstiden.Vil du vide mere om jobbet som ledende assessor, er du velkommen til at kontakte sektionsleder for laboratoriesektionen Kirsten M. Rosenberg (7733 9583) eller ledende assessor Erik Bruun Lorentzen (7733 9562). Ansøgning Send ansøgning med oplysning om dine kvalifikationer og din arbejdsmæssige baggrund hurtigst muligt og senest 22. september 2019 til job@danak.dk. Har du lyst til at arbejde med bedømmelse af akkrediterede laboratorier inden for kalibrering samt fysisk, mekanisk og elektrisk prøvning, og være med til at lægge grundlaget for national og international anerkendelse af laboratorier så er du måske vores nye medarbejder. DANAK er udpeget som det nationale akkrediteringsorgan i Danmark. EU-Kommissionen har anerkendt akkreditering som et centralt element i styrkelse af det Indre Marked. Læs mere om DANAK og Den Danske Akkrediteringsfond på www.danak.dk

Har du lyst til at arbejde med bedømmelse af akkrediterede laboratorier inden for kalibrering samt fysisk, mekanisk og elektrisk prøvning, og være med til at lægge grundlaget for national og international anerkendelse af laboratorier så er du måske vores nye medarbejder.

 

Som ledende assessor hos DANAK får du en uddannelse, der vil lære dig om de metoder vi bruger til bedømmelse af laboratorier og sikre dig forståelse for de akkrediteringsstandarder, som laboratorierne arbejder i henhold til. I uddannelsesforløbet vil du først være observatør på et antal bedømmelser, hvorefter du under supervision selv skal varetage bedømmelse af et antal laboratorier før du godkendes som ledende assessor. Bedømmelsesarbejdet omfatter udvælgelse og ledelse af et bedømmelseshold, som udover dig består af et antal eksperter (tekniske assessorer), oftest 1-2 men i visse tilfælde op til 4-8 eksperter. Du skal desuden koordinere og planlægge bedømmelsen og varetage afrapporteringen og den opfølgning, som ligger til grund for, at et laboratorium kan akkrediteres.

Udover bedømmelse af laboratorier vil du kunne blive inddraget i drift af infrastrukturen i DANAK, som bl.a. omfatter betjening af sektorudvalg, kontakt til myndigheder, deltagelse i internationale arbejdsgrupper og komiteer, afvikling af kurser for de akkrediterede laboratorier samt regelmæssige møder med de tekniske assessorer.

Vi kan tilbyde spændende og afvekslende arbejdsopgaver i et dynamisk miljø, med gode kollegaer og en uformel omgangstone. Du kommer til at arbejde i laboratoriesektionen både på vores kontor i Skovlunde og hos de akkrediterede laboratorier i hele landet. Da der er en vis rejseaktivitet knyttet til arbejdet med lange arbejdsdage til følge, vil du have flekstid og gode muligheder for fleksibilitet i at planlægge dit arbejde.

Om os
DANAK (Den danske Akkrediteringsfond) er en selvstændig og uafhængig fond, og er Danmarks nationale akkrediteringsorgan, som foretager akkreditering af danske virksomheder.

DANAKs mission er at sikre troværdig dokumentation for overholdelse af kravspecifikationer gennem akkreditering. Det gør vi ved at akkreditere laboratorier, certificerings- og inspektionsorganer mv. til at kalibrere, måle, certificere og foretage inspektioner efter internationale standarder. Vi har et tæt samarbejde med myndigheder i Danmark og akkrediteringsorganer i andre lande.

DANAK har 30 fastansatte medarbejdere, hvoraf 23 er ledende assessorer, samt 130 eksperter tilknyttet. DANAK har akkrediteret ca. 200 laboratorier, 40 certificeringsorganer og 50 inspektionsorganer.

Om dig
Vi forestiller os, at du er akademiker eller tilsvarende med en relevant naturvidenskabelig uddannelse f. eks. som maskin-, bygnings- eller elektroingeniør og med minimum fem års erhvervserfaring. Det er en fordel, hvis du har erfaring fra et eller flere af følgende områder:
• Kalibrering, måleteknik og estimering af måleusikkerhed
• Laboratoriearbejde
• Kvalitetssikring (f. eks. inden for ISO standarder og/eller andet)
• Auditor (intern eller ekstern)
• Undervisning f. eks. afholdelse af kurser
• Myndighedsarbejde

I jobbet er der brug for at du har gode kommunikationsevner - både skriftligt og mundtligt på dansk og engelsk. Desuden forventer vi, at du har en positiv tilgang til vores kunder og overskud til at klare en til tider meget travl arbejdsdag.

Om vilkårene
Vi har 37 timers arbejdsuge inklusiv frokost, flekstidsordning og flere personalegoder f. eks. sundhedsforsikring og massageordning. Da rejseaktivitet er en del af jobbet, indgår dette som en del af arbejdstiden.
Vil du vide mere om jobbet som ledende assessor, er du velkommen til at kontakte sektionsleder for laboratoriesektionen Kirsten M. Rosenberg (7733 9583) eller ledende assessor Erik Bruun Lorentzen (7733 9562).

Ansøgning
Send ansøgning med oplysning om dine kvalifikationer og din arbejdsmæssige baggrund hurtigst muligt og senest 22. september 2019 til job@danak.dk.

Har du lyst til at arbejde med bedømmelse af akkrediterede laboratorier inden for kalibrering samt fysisk, mekanisk og elektrisk prøvning, og være med til at lægge grundlaget for national og international anerkendelse af laboratorier så er du måske vores nye medarbejder.

DANAK er udpeget som det nationale akkrediteringsorgan i Danmark.

EU-Kommissionen har anerkendt akkreditering som et centralt element i styrkelse af det Indre Marked. Læs mere om DANAK og Den Danske Akkrediteringsfond på www.danak.dk

 

DANAK DEN DANSKE AKKREDITERINGSFONDSkovlunde2019-08-23T00:00:002019-09-22T00:00:00
da-DK

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Har du lyst til at arbejde med bedømmelse af akkrediterede laboratorier inden for kalibrering samt fysisk, mekanisk og elektrisk prøvning, og være med til at lægge grundlaget for national og international anerkendelse af laboratorier så er du måske ...
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