QA/QE Specialist for Finished Goods Manufacturing and Drug Substance MFG
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Hillerød
Are you a self-driven and motivated team-player with a “go-do” attitude, and are you a person who takes ownership and responsibility of your assignments? Then you might be our new colleague!
We are currently looking for an experienced person with a technical background and experience from working in a GMP environment to join our Quality Assurance Engineering team in Hillerød.
This team is part of the Quality Assurance Operations department for Finished Goods Manufacturing (FGM) and Drug Substance Manufacturing (DSM). Since the Quality Engineering team is an integrated part of the change and improvement processes, candidates with a background outside quality are also encouraged to apply.
In collaboration with stakeholders you’ll be supporting our construction, engineering and automation activities on review and approval of validation strategies, engineering documents, test protocols, CAPAs, deviations, change controls and any technical documentation where QA needs to approve before implementation and upon completion. You’ll also be an active member of cross functional groups where quality input is needed.
Primary Responsibilities
• Execute QE activities during change overs from one product to another
• Review/approval validation documentation and additional test of protocols and reports
• Review/approval of change control/Deviations documents and activities associated with change control implementation
• Support Automation / IT function on smaller and larger projects.
• Review documentation for compliance to internal procedures and applicable regulatory and corporate guidance documents.
• Identify and implement improvements of operations both in your own function and cross functionally
Qualifications
We are looking for a high performing and driven individual who values strong teamwork at all levels and perform their work with an open mind and a sense of humour. Furthermore, we are looking for the following:
• Several years of experience with bio-pharmaceutical production of FGM and/or DSM are required.
• Knowledge of bio-pharmaceutical production within Fill Finish, Utility, Pen’s/devices and Automation/IT are an advantage.
• Experience with qualification/validation of IT systems and/or production equipment
• Good communication skills and fluency in English
Education
B.Sc. or M.Sc. in Physical, Chemical or Biological Science, Technical Engineer or equivalent.
Please upload your CV and cover letter as soon as possible and latest by 3rd of May.
FUJIFILM Diosynth Biotechnologies is an industry-leading biologics Contract Development and Manufacturing Organization (CDMO) with locations in Teesside, UK, RTP, North Carolina, College Station, Texas and Hillerod, Denmark. We have over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. Delivering recombinant proteins, viral vaccines and gene therapies to patients requires commitment and partnership. We have become a trusted partner to some of the most prominent biotech developers and pharmaceutical companies in the industry where we are currently licensed for the commercial manufacture of 14 approved products.
The Manufacturing site in Hillerød brings together a complete range of expertise, capabilities and technologies to manufacture advanced biologics. The large scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. The facility for medical device assembly, labeling and packaging manufactures advanced delivery systems and ensures required labeling and secure packaging of the therapies for patients worldwide. The site also houses quality control laboratories, warehouses, and a number of organizations, supporting the manufacturing activities: process science, supply chain management, engineering and quality assurance.
Our people are what make FUJIFILM Diosynth Biotechnologies standout. We recruit talented and passionate people, each playing a vital role in our success. At FUJIFILM Diosynth Biotechnologies, you will gain hands-on experience in an industry-leading biologics contract development and manufacturing organization. You will work with highly-skilled and experienced professionals of different nationalities and backgrounds, engaging in challenging work by delivering solutions for the biopharmaceutical industry.
We aim to foster a collaborative, innovative, diverse and rewarding environment, where it is possible to develop and learn. We pursue our fullest potential as individual contributors and team members. As part of our team, every one is a valuable contributor in the advancement of tomorrow’s medicine. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.
Kilde: Jobnet.dk
We are currently looking for an experienced person with a technical background and experience from working in a GMP environment to join our Quality Assurance Engineering team in Hillerød.
This team is part of the Quality Assurance Operations department for Finished Goods Manufacturing (FGM) and Drug Substance Manufacturing (DSM). Since the Quality Engineering team is an integrated part of the change and improvement processes, candidates with a background outside quality are also encouraged to apply.
In collaboration with stakeholders you’ll be supporting our construction, engineering and automation activities on review and approval of validation strategies, engineering documents, test protocols, CAPAs, deviations, change controls and any technical documentation where QA needs to approve before implementation and upon completion. You’ll also be an active member of cross functional groups where quality input is needed.
Primary Responsibilities
• Execute QE activities during change overs from one product to another
• Review/approval validation documentation and additional test of protocols and reports
• Review/approval of change control/Deviations documents and activities associated with change control implementation
• Support Automation / IT function on smaller and larger projects.
• Review documentation for compliance to internal procedures and applicable regulatory and corporate guidance documents.
• Identify and implement improvements of operations both in your own function and cross functionally
Qualifications
We are looking for a high performing and driven individual who values strong teamwork at all levels and perform their work with an open mind and a sense of humour. Furthermore, we are looking for the following:
• Several years of experience with bio-pharmaceutical production of FGM and/or DSM are required.
• Knowledge of bio-pharmaceutical production within Fill Finish, Utility, Pen’s/devices and Automation/IT are an advantage.
• Experience with qualification/validation of IT systems and/or production equipment
• Good communication skills and fluency in English
Education
B.Sc. or M.Sc. in Physical, Chemical or Biological Science, Technical Engineer or equivalent.
Please upload your CV and cover letter as soon as possible and latest by 3rd of May.
FUJIFILM Diosynth Biotechnologies is an industry-leading biologics Contract Development and Manufacturing Organization (CDMO) with locations in Teesside, UK, RTP, North Carolina, College Station, Texas and Hillerod, Denmark. We have over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. Delivering recombinant proteins, viral vaccines and gene therapies to patients requires commitment and partnership. We have become a trusted partner to some of the most prominent biotech developers and pharmaceutical companies in the industry where we are currently licensed for the commercial manufacture of 14 approved products.
The Manufacturing site in Hillerød brings together a complete range of expertise, capabilities and technologies to manufacture advanced biologics. The large scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. The facility for medical device assembly, labeling and packaging manufactures advanced delivery systems and ensures required labeling and secure packaging of the therapies for patients worldwide. The site also houses quality control laboratories, warehouses, and a number of organizations, supporting the manufacturing activities: process science, supply chain management, engineering and quality assurance.
Our people are what make FUJIFILM Diosynth Biotechnologies standout. We recruit talented and passionate people, each playing a vital role in our success. At FUJIFILM Diosynth Biotechnologies, you will gain hands-on experience in an industry-leading biologics contract development and manufacturing organization. You will work with highly-skilled and experienced professionals of different nationalities and backgrounds, engaging in challenging work by delivering solutions for the biopharmaceutical industry.
We aim to foster a collaborative, innovative, diverse and rewarding environment, where it is possible to develop and learn. We pursue our fullest potential as individual contributors and team members. As part of our team, every one is a valuable contributor in the advancement of tomorrow’s medicine. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.
Kilde: Jobnet.dk
Information og data
Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Hillerød.
Jobbet er oprettet på vores service den 30.4.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Forsker
- Hillerød
- Søndag den 03. maj 2020
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