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QA-specialist, der er QP-delegeret eller drømmer om at blive det

Drømmer du om at bidrage til at sikre kvaliteten af livsvigtige lægemidler, der redder liv? Er du en erfaren kvalitetsspecialist med erfaring fra lægemiddelproduktion?

Som delegeret Qualified Person (QPd) i vores Manufacturing QA (MQA) afdeling får du en unik mulighed for at arbejde med kvalitetssikring og frigivelse af Xellias produkter. Du vil være med til at sikre, at vores antibiotika når frem til patienter i hele verden i den højeste kvalitet. Som delegeret QP hos Xellia får du et stort ansvar.

Regulatory Affairs Clinical Specialist

Due to many activities in our exciting clinical development projects, we are seeking two new colleagues to our Regulatory Affairs function.

Your key responsibilities will be to contribute with regulatory expertise to global strategies and execution within your assigned project(s). You will be the regulatory responsible in the clinical trial teams and provide regulatory guidance and support for the planning, execution, and reporting of clinical trials worldwide.

Business Developer with a background in Science

Do you want to be at the forefront of Targeted Radiopharmaceuticals and Molecular Imaging?

We are looking for a professional Business Developer with a background in life sciences and the ambition to contribute to further strengthening Minerva Imaging as the trusted partner for targeted radiopharmaceuticals and molecular imaging.

What truly matters is your passion for the advancement and know-how of our scientific studies and your ability to foster long-term relationships with our collaborators.

Clinical Trial Assistant

Are you looking for the possibility to unfold your competences within clinical operations even further? Do you thrive in an innovative environment working alongside dedicated clinical research professionals? Are you a self-driven team player, who enjoys a varied and influential day at work?

Pharmacosmos A/S is a progressive and innovative pharmaceutical company with headquarters in Holbæk, Denmark. We are on an exciting journey of global growth inventing new and innovative treatments, and right now we are expanding our team with a Clinical Trial Assistant.

Manager Virus Production

Do you want to play a central and important role in Bavarian Nordic´s manufacturing strategy by setting directions and ensuring smooth daily operation in our production facility?

Our newly established Drug Substance Facility in Kvistgaard will soon start production ramp-up, and we therefore need to strengthen our leadership. You will become responsible for the day-to-day shopfloor management of 15-20 operators.

Specialist, Regulatory Affairs (Temporary Position)

As Regulatory Affairs Specialist, you will be responsible for lifecycle management of products manufactured at Orifarm’s own manufacturing sites. Therefore, you will collaborate closely with colleagues across functions, such as chemists, formulation specialists and co-workers within Quality, Supply Chain, Manufacturing and Sales.

Further, your main responsibilities include to:

• Gather information and documentation for variation applications
• Update dossier sections

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.

Application Specialist – Beverages

Are you passionate about product development within all types of beverages from premium organic CSD's to flavored spirits?

You will work in a high-paced, collaborative and energetic environment optimizing key elements of beverage applications such as taste, stability, preservation and appearance with the goal to design the perfect balance between these elements.

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.

Senior Medical Writer

Do you want to work in a global context and according to the highest standards of current practice to provide new products to patients with unmet medical needs?

As a Senior Medical Writer, you will be responsible for delivering submission-ready documents and take the role as lead medical writer on specific assignments. In addition, you can look forward to joining a diverse organisation shaped by cross-functional and global collaboration – and a focus on continuous transformation to support the future needs of clinical development.

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.

Technician, EMA Solids Support Team

Welcome to Solid Support Team 13 skilled process engineers and technicians responsible for quality, introducing new products, throughput, and optimizing the products.

In this role you’ll make an impact by:

• Responsible technician for the MG-coating line, ensuring smooth and efficient coating processes for granulating with MnTACN
• Coordinate the steering system changes, bridging the gap between process engineers, technicians, and programmers to optimize operational efficiency.

Associate Sensory scientist/Sensory Panel Lead - Arla Innovation Centre, Aarhus

We are looking for two new Sensory Panel Leads. One new collegue for a 1 year maternity cover and one for a 3 year project. For both positions we hope we will be able to prolong the employment or offer new challenges within Arla Foods.

Your key responsibilities will be:

• In close contact with stakeholders, guide and choose the proper test-setup to deliver the sensory results needed
• Panel training and development of panel competences within specific areas of interest

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.

Senior Product Test Engineer - Medical Devices

Do you want to design safe and reliable medical devices, bringing our clients' life-changing solutions into the hands of patients and helping patients to get better treatment?

You will be an essential contributor in the development and designing optimal verification methods for requirement confirmation.

We seek to enable the best work environment that helps you and the business work together to produce superior results.

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

Head of the Department of Virus & Microbiological Special Diagnostics

Do you have solid management experience and deep insight and experience within virology?

As Head of the Department of Virus & Microbiological Special Diagnostics, you are responsible for the daily management of the department to ensure the diagnostic preparedness for infection in a one-health perspective with synergy between laboratory diagnostics in humans and animals.

Senior Specialist Clinical Safety and Pharmacovigilance (CSPV)

At Bavarian Nordic, we aspire to save and improve lives by developing innovative vaccines that are designed to unlock the power of the immune system.

The global team consists of subject matter experts for vaccine safety who work either from our site or remotely in Denmark and globally. Together they constantly collect and assess data for the life cycle benefit risk management across our vaccines whether authorized or still in clinical development.

You would add your clinical safety and pharmacovigilance expertise as your depth knowledge of the PV legislation to the team.