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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.dkDKDanmarkDKDanmark329925482Senior Associate (QA Specialist/Delegated QP)Robot 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

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

BIOGEN (DENMARK) NEW MANUFACTURINGApSHillerød2018-12-10T00:00:002019-01-14T00:00:00
329911241Senior Associate, Quality AssuranceRobot Do you have solid GMP knowledge and do you have experience with electronic batch records? Then you might be the person we are looking for! Job Category Quality Requisition Number 35911BR Job Description We are currently looking for a Senior Associate to our QA team for Large Scale Manufacturing operations in Hillerod.As Senior Associate you will perform QA support for drug substance manufacturing and assure cross site alignment on applications supporting the production and release processes. You will also assess drug substance quality through review of solution lot records and batch production records and through being on the floor during manufacturing as applicable. Furthermore, you will develop and maintain the quality systems related to the quality processes supporting drug substance manufacture based on current GMP and regulatory requirements. Primary Responsibilities - Perform QA support to projects related to applications supporting drug substance manufacture and disposition - Perform QA review and approval of change controls and QA documents related herewith - Perform timely QA review and approval of batch documentation for drug substance including assessment of the process parameters and solution lots utilized during batch manufacturing and QA review of other relevant documentation - Coordinate responses to observations, collection of data for APR and PQR within the drug substance area and maintain systems and applications related to drug substance manufacture and disposition. Establish and maintain metrics within the QA LSM Operations department - 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 - Work experience from pharmaceutical industry, in QA preferable including knowledge from up- and down stream processes - Knowledge and understanding of systems and applications used within manufacturing and dispositioning of pharmaceutical products - Experience from working with automation in pharmaceutical industry and or implementing electronic batch records is preferred - Work experience or educational background that allows for understanding of the complexity of manufacturing biologics - Knowledge of GMP and quality systems - Good communication skills and at good at creating structure Education - Master of Science in a natural science, e.g. Pharmacy, Biotechnology, Biology or similar Employment Category Full-Time Regular Experience Level Mid-Senior Level

Do you have solid GMP knowledge and do you have experience with electronic batch records? Then you might be the person we are looking for!

Job Category

Quality

Requisition Number

35911BR

Job Description

We are currently looking for a Senior Associate to our QA team for Large Scale Manufacturing operations in Hillerod.As Senior Associate you will perform QA support for drug substance manufacturing and assure cross site alignment on applications supporting the production and release processes. 

You will also assess drug substance quality through review of solution lot records and batch production records and through being on the floor during manufacturing as applicable. 

Furthermore, you will develop and maintain the quality systems related to the quality processes supporting drug substance manufacture based on current GMP and regulatory requirements.

Primary Responsibilities

- Perform QA support to projects related to applications supporting drug substance manufacture and disposition

- Perform QA review and approval of change controls and QA documents related herewith

- Perform timely QA review and approval of batch documentation for drug substance including assessment of the process parameters and solution lots utilized during batch manufacturing and QA review of other relevant documentation

- Coordinate responses to observations, collection of data for APR and PQR within the drug substance area and maintain systems and applications related to drug substance manufacture and disposition. Establish and maintain metrics within the QA LSM Operations department

- 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

- Work experience from pharmaceutical industry, in QA preferable including knowledge from up- and down stream processes

- Knowledge and understanding of systems and applications used within manufacturing and dispositioning of pharmaceutical products

- Experience from working with automation in pharmaceutical industry and/or implementing electronic batch records is preferred

- Work experience or educational background that allows for understanding of the complexity of manufacturing biologics

- Knowledge of GMP and quality systems

- Good communication skills and at good at creating structure

Education

- Master of Science in a natural science, e.g. Pharmacy, Biotechnology, Biology or similar

Employment Category

Full-Time Regular

Experience Level

Mid-Senior Level

BIOGEN (DENMARK) NEW MANUFACTURINGApS2018-12-10T00:00:002019-01-11T00:00:00
da-DK

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