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Quality Professional

Do you have solid GMP knowledge and some experience working in the pharmaceutical industry? Then we have a great new opportunity for you!

Job Category

Quality

Requisition Number

34235BR

Job Description

We are currently looking for a Quality Professional to join our QA LSM Operations team in Hillerød!

In this role, you will assess drug substance quality through review of solution lot records and batch production records and by being on the floor during manufacturing as applicable. 

You will also maintain the quality system related to the exceptions and disposition processes based on current GMP, GDP and regulatory requirements. 

Primary Responsibilities
- Perform timely QA review and approval of batch documentation for drug substance through assessment of the process parameters, solution lots, and batch production records utilized during batch manufacturing
- Act as primary QA contact for the LSM Compliance team, Manufacturing Management, Engineers, and Manufacturing Associates when investigations are ongoing to resolve deviations and/or CAPAs related to the manufacturing process for drug substance. Including participation in on-line trouble shooting and investigations as needed
- Perform review and approval of documentation, deviations, CAPA etc. in connection to batch disposition
- Participate in execution of audits and inspections from competent authorities and external parties and act as subject matter expert
- Maintain internal training level and keep up to date on cGMPs and regulatory requirements as well as on global procedures, guidelines, policies, frames, and specifications

Qualifications

- Solid GMP knowledge and QA and/or manufacturing experience from the pharmaceutical industry
- Work experience or educational background that allows for understanding of the complexity of manufacturing biologics

Education

- Preferably Master of Science, e.g. Pharmacy, Biotechnology, Biology or similar

Employment Category

Full-Time Regular

Experience Level

Associate


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329788917Phoenix-617c13d912018-04-06T00:00:00Quality Professional

Do you have solid GMP knowledge and some experience working in the pharmaceutical industry? Then we have a great new opportunity for you!

Job Category

Quality

Requisition Number

34235BR

Job Description

We are currently looking for a Quality Professional to join our QA LSM Operations team in Hillerød!

In this role, you will assess drug substance quality through review of solution lot records and batch production records and by being on the floor during manufacturing as applicable. 

You will also maintain the quality system related to the exceptions and disposition processes based on current GMP, GDP and regulatory requirements. 

Primary Responsibilities
- Perform timely QA review and approval of batch documentation for drug substance through assessment of the process parameters, solution lots, and batch production records utilized during batch manufacturing
- Act as primary QA contact for the LSM Compliance team, Manufacturing Management, Engineers, and Manufacturing Associates when investigations are ongoing to resolve deviations and/or CAPAs related to the manufacturing process for drug substance. Including participation in on-line trouble shooting and investigations as needed
- Perform review and approval of documentation, deviations, CAPA etc. in connection to batch disposition
- Participate in execution of audits and inspections from competent authorities and external parties and act as subject matter expert
- Maintain internal training level and keep up to date on cGMPs and regulatory requirements as well as on global procedures, guidelines, policies, frames, and specifications

Qualifications

- Solid GMP knowledge and QA and/or manufacturing experience from the pharmaceutical industry
- Work experience or educational background that allows for understanding of the complexity of manufacturing biologics

Education

- Preferably Master of Science, e.g. Pharmacy, Biotechnology, Biology or similar

Employment Category

Full-Time Regular

Experience Level

Associate

2018-05-07T00:51:07.617 Do you have solid GMP knowledge and some experience working in the pharmaceutical industry? Then we have a great new opportunity for you! Job Category Quality Requisition Number 34235BR Job Description We are currently looking for a Quality Professional to join our QA LSM Operations team in Hillerød! In this role, you will assess drug substance quality through review of solution lot records and batch production records and by being on the floor during manufacturing as applicable. You will also maintain the quality system related to the exceptions and disposition processes based on current GMP, GDP and regulatory requirements. Primary Responsibilities - Perform timely QA review and approval of batch documentation for drug substance through assessment of the process parameters, solution lots, and batch production records utilized during batch manufacturing - Act as primary QA contact for the LSM Compliance team, Manufacturing Management, Engineers, and Manufacturing Associates when investigations are ongoing to resolve deviations and or CAPAs related to the manufacturing process for drug substance. Including participation in on-line trouble shooting and investigations as needed - Perform review and approval of documentation, deviations, CAPA etc. in connection to batch disposition - Participate in execution of audits and inspections from competent authorities and external parties and act as subject matter expert - Maintain internal training level and keep up to date on cGMPs and regulatory requirements as well as on global procedures, guidelines, policies, frames, and specifications Qualifications - Solid GMP knowledge and QA and or manufacturing experience from the pharmaceutical industry - Work experience or educational background that allows for understanding of the complexity of manufacturing biologics Education - Preferably Master of Science, e.g. Pharmacy, Biotechnology, Biology or similar Employment Category Full-Time Regular Experience Level Associate11Jobnet617c13d9100000000000IDK_OFIR_02DKDanmark228DKK2018-05-06T00:00:000000https://sjobs.brassring.com/TGnewUI/Search/home/HomeWithPreLoad?PageType=JobDetails&noback=0&partnerid=169&siteid=5140&jobid=8055600EuropaDanmarkEuropaDanmarkSjælland & øerStorkøbenhavnAllerødEuropaDanmarkSjælland & øerNordsjællandFredensborgEuropaDanmarkSjælland & øerNordsjællandHillerød3207692BIOGEN (DENMARK) NEW MANUFACTURINGApS11Biogen Alle 13400Hillerød77416999DKDanmark0
DKDanmarkDKDanmark
8Fuldtid46Permanent550621JobNet48052931000https://dispatcher.ofir.dk/statistic/register?context=FeedEntrySearchedCount&feedId=dc2beb84&entryId=617c13d9https://dispatcher.ofir.dk/statistic/register?context=FeedEntryDisplayCount&feedId=dc2beb84&entryId=617c13d9https://dispatcher.ofir.dk/statistic/register?context=JobApplicationInitiatedCount&feedId=dc2beb84&entryId=617c13d9&page=ShowJob&component=SendApplicationButtonhttps://dispatcher.ofir.dk/statistic/register?context=JobApplicationAppliedCount&feedId=dc2beb84&entryId=617c13d9&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/ tale315218Kvalitetsmedarbejder0Øvrige354196617Biogenjom@workindenmark.dkDKDanmarkDKDanmark329973506Senior Quality Specialist for auditsRobot Do you want to be part of a highly motivated, dynamic team driving the change through our offshore wind business? Join us and become Senior Quality Specialist in IMS Support, Process Excellence and Compliance where you ll be responsible for leading audits of all kinds across our Offshore business. You ll become part of a team of highly skilled quality specialists, focused on improving our management system, implementing and maintaining our ISO certifications and supporting the company s quality journey towards best in class . Your key tasks will be to lead and conduct internal audits and assessments across the company drive planning of and prepare selected parts of the organisation in pre-certification activities participate in external certification activities be a key player in the development of the audit strategy and annual audit programme support the development of audit reporting. Your competences include that you have a bachelor s or master s degree in a relevant subject are a lead auditor with extensive internal and external auditing experience have experience with ISO 9001 and or ISO 55001 have a proven track record of working in a complex organisation speak and write English fluently thrive in an international environment and are able to create good relationships with your stakeholders. In addition, you re a motivated self-starter who can work both independently and in a team. You need to have a proactive and systematic approach to your work and strong networking skills in order to build lasting relationships across our many stakeholders. You re good at seeking out new improvement opportunities and good at training giving presentations. You need to have the ability to communicate with colleagues at all levels across several countries and be an ambassador for quality management within the organisation. It ll be beneficial to have experience with offshore wind power. Experience auditing to KLS, BEK73 and BEK100 is an advantage, but not essential. Working at Ørsted To be the frontrunner in the green energy transformation, we invest significantly in innovation and empower our employees to help shape the renewable energy technologies of the future. We cultivate a collaborative, dynamic and diverse work environment and encourage career-long learning and development so our people can realise their full potential. Would you like to help shape the renewable technologies of the future? Send your application to us as soon as possible and no later than 25 March 2019, as we ll be conducting interviews on a continuous basis. For Denmark, please don t hesitate to contact Emily Spearman, Head of IMS Support Process Excellence and Compliance of Offshore Quality, by telephone on 44 77 68 46 52 90 if you d like to know more about the position. For the United Kingdom, please don t hesitate to contact the Recruitment Specialist by email on ukrecruitment@orsted.co.uk. All UK-based positions will be subject to satisfactory pre-employment screening, further details will be given at offer stage. Please note that for your application to be taken into consideration, you must submit your application via our online career pages. This role will involve travel to sites and other locations within the organisation. About Ørsted Headquartered in Denmark, Ørsted s 6,000 employees develop, construct and operate offshore and onshore wind farms, bioenergy plants and innovative waste-to-energy solutions and provide smart energy products to its customers. Ørsted Offshore s 2,300 employees have developed and constructed the largest portfolio of offshore wind farms in Northern Europe, and we re expanding with international activities in the US and Asia-Pacific. For more information on Ørsted, visit orsted.com.

Do you want to be part of a highly motivated, dynamic team driving the change through our offshore wind business? 

Join us and become Senior Quality Specialist in IMS Support, Process Excellence and Compliance where you’ll be responsible for leading audits of all kinds across our Offshore business. You’ll become part of a team of highly skilled quality specialists, focused on improving our management system, implementing and maintaining our ISO certifications and supporting the company’s quality journey towards ‘best in class’.


Your key tasks will be to

  • lead and conduct internal audits and assessments across the company
  • drive planning of and prepare selected parts of the organisation in pre-certification activities
  • participate in external certification activities
  • be a key player in the development of the audit strategy and annual audit programme
  • support the development of audit reporting.

 

Your competences include that you

  • have a bachelor’s or master’s degree in a relevant subject
  • are a lead auditor with extensive internal and external auditing experience
  • have experience with ISO 9001 and/or ISO 55001
  • have a proven track record of working in a complex organisation
  • speak and write English fluently
  • thrive in an international environment and are able to create good relationships with your stakeholders.

 

In addition, you’re a motivated self-starter who can work both independently and in a team. You need to have a proactive and systematic approach to your work and strong networking skills in order to build lasting relationships across our many stakeholders. You’re good at seeking out new improvement opportunities and good at training/giving presentations. You need to have the ability to communicate with colleagues at all levels across several countries and be an ambassador for quality management within the organisation. 

It’ll be beneficial to have experience with offshore wind power. Experience auditing to KLS, BEK73 and BEK100 is an advantage, but not essential.

 

Working at Ørsted

To be the frontrunner in the green energy transformation, we invest significantly in innovation and empower our employees to help shape the renewable energy technologies of the future. We cultivate a collaborative, dynamic and diverse work environment and encourage career-long learning and development so our people can realise their full potential.

 

Would you like to help shape the renewable technologies of the future?

Send your application to us as soon as possible and no later than 25 March 2019, as we’ll be conducting interviews on a continuous basis. 

For Denmark, please don’t hesitate to contact Emily Spearman, Head of IMS Support Process Excellence and Compliance of Offshore Quality, by telephone on +44 77 68 46 52 90 if you’d like to know more about the position. 

For the United Kingdom, please don’t hesitate to contact the Recruitment Specialist by email on ukrecruitment@orsted.co.uk. 

All UK-based positions will be subject to satisfactory pre-employment screening, further details will be given at offer stage. 

Please note that for your application to be taken into consideration, you must submit your application via our online career pages. 

This role will involve travel to sites and other locations within the organisation.

 

About Ørsted

Headquartered in Denmark, Ørsted’s 6,000 employees develop, construct and operate offshore and onshore wind farms, bioenergy plants and innovative waste-to-energy solutions and provide smart energy products to its customers. Ørsted Offshore’s 2,300 employees have developed and constructed the largest portfolio of offshore wind farms in Northern Europe, and we’re expanding with international activities in the US and Asia-Pacific. For more information on Ørsted, visit orsted.com.

Ørsted Vind A/SGentofte2019-03-07T00:00:002019-03-25T00:00:00
329955607møbel montørRobot OX denmarq søger møbel montør Mindre møbelproducerende designvirksomhed i rivende udvikling søger ildsjæl med møbelerfaring til produktion i Skovlunde. Arbejdsopgaverne er som udgangspunkt: - Serieproduktion af stole hovedsageligt montering af møbler med læder på stålstel, men også lettere produktion af komponenter til møblerne. - Udvikling og indkøring af nye produkter. Hvem er den rigtige person? Vi søger en ansvarsbevidst, kreativ person, der både kan håndtere serieproduktion af eksisterende modeller og som ser løsninger før problemer. Nøgleord for stillingen er selvstændighed, fleksibilitet og sans for at levere produkter af høj kvalitet og erfaring med møbel fremstilling eller ligende. Det er som udgangspunkt en person, der skal kunne arbejde på egen hånd og yde en ekstra indsats i perioder med spids belastning. En person med de rigtige evner og den rigtige indstilling, der aktivt med sin indsats bidrager til OX denmarqs forsatte udvikling vil kunne se frem til en særdeles spændende arbejdsplads i mange år fremover.

OX denmarq søger møbel montør

Mindre møbelproducerende designvirksomhed i rivende udvikling søger ildsjæl med møbelerfaring til produktion i Skovlunde.

Arbejdsopgaverne er som udgangspunkt:

- Serieproduktion af stole – hovedsageligt montering af møbler med læder på stålstel, men også lettere produktion af komponenter til møblerne.

- Udvikling og indkøring af nye produkter.

Hvem er den rigtige person?

Vi søger en ansvarsbevidst, kreativ person, der både kan håndtere serieproduktion af eksisterende modeller og som ser løsninger før problemer. Nøgleord for stillingen er selvstændighed, fleksibilitet og sans for at levere produkter af høj kvalitet og erfaring med møbel fremstilling eller ligende.

Det er som udgangspunkt en person, der skal kunne arbejde på egen hånd og yde en ekstra indsats i perioder med spids belastning.

En person med de rigtige evner og den rigtige indstilling, der aktivt med sin indsats bidrager til OX denmarqs forsatte udvikling vil kunne se frem til en særdeles spændende arbejdsplads i mange år fremover.

OX DENMARQSkovlunde2019-02-06T00:00:002019-04-01T00:00:00
da-DK

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