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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.

Lead Automation Engineer til Pharmadivisionen

Har du en god procesforståelse og erfaring med at arbejde i pharmabranchen, kan du måske se dig selv som Lead Automation Engineer i Pharmadivisionen.

Vi søger to nye kollegaer med en stærk automationsfaglig erfaring og kendskab til at arbejde med sterile processer. Du bliver en del af afdelingen: C&Q/Automation – en nyere afdeling som vi er godt i gang med at opbygge. På nuværende tidspunkt består den af syv dedikerede medarbejdere, der arbejder med commissioning, automation og test af anlæg. Her vil du indtage en central rolle som specialist på automationsområdet, og du vil få rig mulighed for at være med til at udvikle C&Q/Automation-afdelingen.

Senior Commissioning & Qualification Engineer

Vi søger en Commissioning & Qualification Engineer, der elsker at blive udfordret inden for sit fag, og som deler vores passion for at arbejde med pharma.

Du vil komme til at arbejde med projekter inden for idriftsættelse, test og fejlfinding på anlæg - hovedsageligt på projekter i pharmasektoren. Stillingen berører stort set alle aspekter inden for idriftsættelse, og det er vigtigt for os, at du har en solid erfaring med maskin- og processtyring samt praktisk idriftsættelse.

Du får rig mulighed for at være med til at præge udviklingen af afdelingen, hvor vi gør en stor indsats for at skabe et godt sammenhold i en travl hverdag.

Automationsingeniør med erfaring indenfor Pharma

Vil du arbejde med spændende og varierende projekter indenfor automation og kunne du tænke dig at blive del af et dygtigt tværfagligt team, hvor humøret og ambitionerne er tårnhøje?

Vi arbejder i Pharma automation teamet dedikeret med design, programudvikling, indkøring, test og kvalificering af procesløsninger til vores pharma og biotech kunder og du bliver således en del af vores tværfaglige projektteams.

På kontoret i Kalundborg vil du indgå i et professionelt fagmiljø, hvor der er fokus på vidensdeling og det gode samarbejde. Din dagligdag bliver præget af gode kollegaer, faglige udfordringer og stor medbestemmelse.

Test & Reliability Engineer - Sustaining Engineering, Medical Devices

Do you have a keen eye for Physical Testing, Product Quality, Reliability, Validation, and Documentation? Are you looking for an opportunity to merge your passion with our expertise in the Test and Verification of Infusion Care Medical Devices, for the treatment of chronic diseases such as Diabetes and Parkinson’s Disease?

As a Test Engineer, you will be involved in developing and working with a diversity of physical test methods. Planning and coordinating tests in our laboratory in Osted near Roskilde, and partners within Global Convatec and external. Most of your time, you will be part of a project team in SEG.

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.

Senior Vice President, Global Chief Medical Office

We are seeking a highly experienced and dynamic medical executive to join our Global Research & Development organisation in a newly established senior leadership role as SVP, Global Chief Medical Office (GCMO).

In this role, you will act as scientific advisor to the EVP of R&D and the Global R&D leadership team, and your primary objective will be to ensure “one global medical voice” for ALK internally and represent the medical voice of ALK externally.

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.

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.

Validation Engineer

As our new Validation Engineer, you will be responsible for validation and qualification of processes and equipment related to customer projects.

Key responsibilities in this role include, but are not limited to:

• Validation and Qualification of processes and equipment when implementing new material.
• Perform Validation and ensure results are accurately documented.

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.

Ingeniør til validering

Vi har brug for en konsulent til et spændende job indenfor kvalificering og validering. Stillingen byder på mange forskellige opgaver og projekter hos vores kunder på det meste af Sjælland, og du får en spændende, travl og varierende hverdag.

Du vil bl.a. koordinere, planlægge og udføre validerings- og kvalificeringsprojekter, som kan omhandle: rengøringsvalidering, sterilisationsprocesser, procesanlæg, IT-validering, klimafaciliteter, produktions-, måle- og laboratorieudstyr.

Technical Specialist, Product Quality, Nourish (Maternity cover, 12 months)

Are you an enthusiastic, motivated and detail-oriented professional with a desire to work in a team of colleagues with great technical competencies within production, regulation and processes?

Your core responsibilities:

• Handling deviations for products manufactured at our factories.
• Handling of product quality related complaints.
• Coordinate and implement customer-specific requirements. Maintenance of master data in various IT systems, including SAP.

Project Manager

Trives du med at arbejde sammen med dedikerede og erfarne kollegaer, der brænder for at udvikle og producere medicinske hjælpemidler til børn og unge med funktionsnedsættelse?

Kan du samtidig se dig selv som projektleder i en specialiseret verden, hvor innovativt design, teknik og brugervenlighed skal gå op i en højere enhed, så er det dig, vi søger i vores R&D-afdeling i Gedved ved Horsens.

Product Compliance Specialist

Ønsker du at arbejde sammen med dedikerede og erfarne kollegaer, der brænder for at udvikle og producere hjælpemidler til børn og unge med funktionsnedsættelse?

Du vil medvirke til at sikre, at de regulatoriske krav til medicinsk udstyr (klasse I) bliver overholdt.

Vi ønsker bl.a. følgende opgaver dækket med vores nye kollega:

• Ansvarlig for godkendelse af nye produkter sammen med R&D teamet
• Deltage i nyudvikling herunder udarbejdelse og godkendelse af regulatorisk dokumentation

Som ansat hos R82 er der stor fokus på både personlig og faglig udvikling af den enkelte medarbejder.

Project Manager - Sustaining Engineering & PMO

We are looking for an experienced Project Manager to join our PMO, Technology and Innovation. You will lead sustaining engineering projects with multidisciplinary teams of engineers and specialists.

You will apply your project management, people leadership, and technical skills to qualify and implement changes to existing products e.g., material changes or quality updates. Together with your team you create clear ambitious plans and ensure projects are delivered on time with agreed quality, scope and cost.

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.

Ruminant Nutritionist – Calf and Lamb Milk Formulations

This is an great opportunity to join our international team that continues to invest in the Ruminant offering looking at way to innovate and enhance our formulations, and additives that support the needs of young animals with some other responsibilities such as:

• Supporting R&D activities, including feed material and product evaluations, trials, and commercial interpretation and communication.
• Develop technical ideas to add value to product sales and marketing.