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Senior Specialist til QC hos Xellia Pharmaceuticals

Drømmer du om mere ansvar, med forskelligartede opgaver, og har du en passion for mikrobiologi? Vil du spille en central rolle i Xellias produktionen af livsvigtig antibiotika?

Som senior specialist vil du blive faglig ansvarlig for vores count release-laboratorie, som bl.a. udfører TVC- og LAL-analyser. Derudover vil du indgå i tæt samarbejde med vores sterile produktioner angående EM, hvor de nye Annex 1-krav stiller øgede krav til vores compliance, som du vil spille en vigtig rolle i.

Senior Data Manager

The Senior Clinical Data Manager is responsible for leading and overseeing data management activities associated with clinical trials, ensuring data accuracy and consistency, and managing data cleaning and quality control processes.

We strongly endorse a flexible working environment around its core working hours of 09:00-15:00 and endorses fair and equal pay practices.

Scientist (maternity leave temp), cell-based immunotherapies

Are you enthusiastic about developing next generation cell-based immunotherapies that bring new hope to late-stage cancer patients?

You will help the R&D team in a 6-months temporary position as one of our coworkers is on maternity leave, and will help the team with a possibility for further extension.

We are looking for a person experienced in immune oncology or related area with documented practical experience in cell culture and flow cytometry.

Biocompatibility Specialist

We are looking for a Biocompatibility Specialist to join the Reprocessing and Biocompatibility team for a 12-month project position.

This is a great opportunity if you would like to gain experience with biocompatibility for advanced reusable medical devices, as you will be part of a cross-functional effort on documenting the safety and performance through the lifetime of our ultrasound scanners, transducers, and accessories.

QA Specialist

We are seeking a competent new colleague to join our QA team in a dynamic and growing company.

You will be part of our highly dedicated team consisting of 5 colleagues working with a broad range of QA tasks such as batch review, processing of complaints, deviations and change requests as well as validation and ad hoc projects.

Training Partner

Are you passionate about designing high impact training to improve ways of working?

The role will focus on re-designing the training related to onboarding our professionals working directly with our operation, our Operators, and our Laboratory Technicians.

You will meet a DK rooted company growing in number of international colleagues and a way of working, where hybrid, digital, learning and innovation are key words.

Regulatory Affairs Specialist

The RA Specialist for Radiometer is responsible for ensuring coordination of regulatory activities for a few of our Blood Gas products manufactured in California to help ensure continued compliance in all markets.

In this role, you will have the opportunity to:

• Facilitate coordination of regulatory activities between California and Denmark for design control activities and international registrations for a few of the instruments/consumables manufactured in our California site.
• Ensure compliance with EU regulations.
• Generate STED files, international submissions & assess design changes.
• Plan and execute projects for new regulatory requirements.

Senior Regulatory Specialist

The Senior Regulatory Affairs Specialist at Radiometer is responsible for collecting and generating documentation for product submissions to ensure compliance with international regulations. This role is critical for ensuring that Radiometer's products can be sold in markets around the world.

If you thrive in a fast-paced environment, are used to playing a critical supporting role and want to work in a world-class efficient team that is part of a Global RA department and have interactions and stakeholders to connect with in a global scale - read on.

Junior QA Specialist søges

Motiveres du af at sikre et godt samspil mellem GMP compliance og den kommercielle drift?

Little Green Pharma er en international medicinsk cannabis virksomhed med hovedkontor i Australien. I vores topmoderne drivhuse i Odense og Perth har vi faciliteterne til at fremstille mere end 23 tons medicinsk cannabis biomasse om året, hvor størstedelen produceres i vores 21.500m2 drivhuse og vores 4.000m2 GMP godkendte produktions-lokaler i Odense, som vi har ambitioner om at vækste over de kommende år til at opnå fuld udnyttelse.

QC Laboratorie Supporter (Barselsvikariat 12 måneder)

Vi søger en person med det rette servicegen og energi, og som forstår kravene i et cGMP QC-laboratorium. Som vores kommende kollega er det vigtigt at du har forståelse for arbejdet i et laboratorie, er indforstået på en travl hverdag med skiftende prioriteringer.

Er det lige dig vi står og mangler, så kan vi tilbyde dig et spændende og udfordrende job i en virksomhed der går en spændende fremtid i møde med mange nye kunder og produkter og store muligheder for personlig udvikling og ansvar. Dette er en tidsbegrænset stilling, men vi udvider og vækster hele tiden så hvem ved hvad fremtiden bringer?

Senior Test Engineer

Join GE HealthCare to help perform transducer integration on our next-generation ultrasound scanners and further develop our test tools and laboratories.

As our new Senior Test Engineer, your typical tasks will include measurements of sound pressure, acoustic power, thermal characteristics, image performance and other transducer properties.

You will take part in hands-on work while also playing a key role in maintaining and further developing our transducer integration processes and two laboratories.

Laborant/Senior Laborant

I jobbet som Laborant/Senior Laborant i Translational Pharmacology vil du være ansvarlig for planlægning, koordinering og gennemførelse af in vivo / ex vivo farmakologiske eksperimenter som bidrag til vores prækliniske forskningsprojekter.

Ansvarsområderne omfatter bl.a.:

• Gennemførelse af in vivo-undersøgelser af høj kvalitet i gnavere, herunder bidrag til protokoller, planlægning, udførelse og dokumentation.
• Udførelse af grundlæggende kirurgi hos gnavere, herunder anæstesi og analgesi.
• Prøvetagning og håndtering af blod- og vævsprøver af høj kvalitet.

LC-MS specialist til analyselaboratorium

Du får det praktiske og faglige ansvar for vores LC-MS laboratorium. Dit hovedfokus bliver at planlægge, drive og koordinere projekter, hvor du indgår som videnskabelig projektleder i hele processen med støtte fra vores andre dygtige specialister.

Du tilbydes ansættelse i en virksomhed i vækst med ca. 20 ansatte, hvor det videnskabelige niveau prioriteres højt og hvor der er en uformel og direkte omgangstone. Du får gode og hjælpsomme kolleger til sparring, og får mulighed for at træde ind i en stilling, hvor du får stort råderum til at planlægge og gennemføre dine arbejdsopgaver og udvikle dine færdigheder og ansvarsområder.

Teknologi-entusiastisk QC-medarbejder

Vi søger lige nu en engageret og kvalificeret LIMS Udvikler i AJ Vaccines til at varetage og implementere vores nye Laboratory Information Management System (LIMS) samt sikre overholdelse af regulatoriske krav. Som LIMS Udvikler vil du komme til at spille en afgørende rolle i vores globale mission om at redde liv verden over.

Du vil være ansvarlig for at implementere og understøtte designet af vores LIMS-system ved at oprette og vedligeholde den Masterdata, der udgør rygraden af vores LIMS, og som er i overensstemmelse med vores strategiske målsætning og regulatoriske krav.

Regulatory Affairs Manager

The Regulatory Affairs Manager at Radiometer is responsible for managing the preparation and submission of the required documentation for product registration, approval, and compliance with international regulations.

This role is critical for ensuring that Radiometer's products can be sold in markets around the world. You will have the opportunity to:

• Ensure regulatory compliance to maintain market approvals
• Lead a team of skilled RA associates
• Ensure alignment with relevant stakeholders

Principal DMPK Scientist

Currently, we are looking for a new principal DMPK scientist, who has experience in supporting discovery and development projects in characterization and selection of drug candidates.

Responsibilities

• Design, conduct, and manage in vitro, and in vivo experiments to evaluate the ADME and PK profiles as well as toxicokinetics of drug candidates both in-house and at contract research organizations
• Develop and execute assays for measuring drug concentration and metabolite identification from in vitro and in vivo experiments

Senior Process Specialist

Do you want to be part of Process Support in a company with a unique impact on global healthcare? Grab this opportunity to be part of a fast-growing company ready to invest in you.

You will become a process owner of one or more of our production processes in SFI. This means that you will be responsible for, among other things, validation documentation, revalidations, and risk assessments for the specific process.

Process Specialist

Do you want to be part of Process Support in a company with a unique impact on global healthcare? Grab this opportunity to be part of a fast-growing company ready to invest in you.

Together with the rest of the team, you will be responsible for the daily support of our production lines. You will learn our processes in detail and gain a good overview of the documentation used in production.

Senior QA Specialist

The Senior QA Specialist for Radiometer is responsible for ensuring safe, reliable, and compliant products during new product development and maintenance of existing product platforms. This is done by cooperating, supporting, facilitating, training, and communicating towards the best results with partners in R&D.

This position is part of the QA Design Control department, hybrid based and located in Brønshøj. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

QA Specialist

You will be responsible for ensuring safe, reliable, and compliant products during new product development and maintenance of existing product platforms.

You will have the opportunity to:

• Provide Design Control guidance for QMS and regulatory compliance in an FDA regulated and ISO compliant environment.
• Represent Quality Assurance in design and development projects and in cross-functional teams supporting new product development.