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ProInvent A/SErfaren profil med ekspertise inden for Quality Management, Regulatory Affairs & Salg

ProInvent A/S, Hørsholm

Hvis du brænder for at skabe Medico og Kombinationsprodukter i verdensklasse, der hjælper med at forbedre menneskers liv, så er du præcis den, vi leder efter.

I det hurtigt voksende produktudviklingsområde i ProInvent A/S hjælper vi vores kunder med at udvikle den næste generation af produkter gennem tæt samarbejde og stærke partnerskaber. Vi benytter vores professionelle færdigheder til at skabe nye innovative løsninger med et stort fokus på kundernes behov, robust design og produktionskvalitet

Vi leder efter en højt kvalificeret profil til at påtage sig rollen som Head of QA/RA, der kan hjælpe vores kunder med at bringe produkter hurtigere på markedet ved at anvende deres kompetencer inden for Quality Management & Regulatory Affairs.

AGC Biologics A/S
Sr. Project Manager

AGC Biologics A/S, Søborg

If you thrive on customer interaction and are looking for a job where your contribution has a direct impact on the business and our growing success, then we have the perfect job for you! We are expanding and are looking for a new Senior Project Manager to help handling our growing portfolio. We hope to hire the right person in January - so don't hesitate to apply now!

As Sr. Project Manager your responsibilities will be providing the necessary program direction for planning, organizing, developing and integrating projects across multiple functional areas. You're expected to closely monitor/control project progression to ensure your project are completed and on schedule within budget.

AGC Biologics A/S
Y-mAbs Therapeutics A/S
Associate Director, PV/GCP Quality Assurance

Y-mAbs Therapeutics A/S, Hørsholm

Y-mAbs Therapeutics A/S is looking for an Associate Director, Quality Assurance in the area of Pharmacovigilance (PV) and Drug Safety, who will be part of a team of highly qualified and motivated colleagues.

It is our expectation that this person will establish QA processes to contribute to Good Pharmacovigilance Practice (GVP) and Good Clinical Practice (GCP) compliance of the company operations.

Key responsibilities

  • Contribute to development of the company Quality Management System and provide guidance in local and global requirements, as applicable to Pharmacovigilance and Clinical Drug Safety
  • Maintain Quality oversight of Pharmacovigilance System Master File, pharmacovigilance SOPs, Safety Management Plans, Pharmacovigilance Agreements, and other relevant documents
Y-mAbs Therapeutics A/S
Fujifilm Diosynth BiotechnologiesQualified Person - Quality Assurance

Fujifilm Diosynth Biotechnologies, Hillerød

Are you a skilled delegated Qualified Person (QP) eager to join a fast growing CDMO? In this position, you will be a crucial part of developing and ensuring our quality aspiration. We are looking for the right candidate who shares our passion, drive, and energy – what we call Genki – to join our Quality Assurance (QA) team.

You will be part of FUJIFILM Diosynth Biotechnologies delegated QP team which consist of 5 people that covers the Biological Drug Substance manufacturing QP disposition activities performed at our Hillerød site. A dynamic team that daily has close collaboration and communication with all internal stakeholders and QA colleagues.

EnvasesQuality Supervisor

Envases, Løsning

Brænder du for kvalitet og samspillet mellem mennesker og processer, så er du måske den nye kollega, vi har brug for til vores fabrik i Løsning. Vi tilbyder dig en hverdag, hvor du skal være med til at sikre og udvikle den gode kvalitet samtidig med at vi overholder de gældende krav til hygiejne.

I stillingen som Quality Supervisor får du et selvstændigt job med reference til Head of Quality & Six Sigma, samtidig med at du kommer til at arbejde tæt sammen med fabriksledelsen i Løsning.

Du får ansvaret for kvalitet og hygiejne, herunder skal du arbejde med relevante standarder såsom ISO9001 og BRC. Desuden får du ansvar for arbejdet med Six Sigma på fabrikken.

LundbeckSenior Research Scientist

Lundbeck, Copenhagen

We are looking for a Senior Research Scientist to join the department of Medicinal Chemistry. As an outstanding medicinal chemist with documented results you have the opportunity to become a Senior Research Scientist in Medicinal Chemistry at the Lundbeck Research Centre in Copenhagen Denmark (DK).

As a Senior Research Scientist in Medicinal Chemistry you will be involved in all aspects of the medicinal chemistry value chain and expected to provide scientific oversight and accept accountability of medicinal chemistry activities in assigned projects. You will be working in a strong team environment within Medicinal Chemistry and will form strong and effective collaborations with scientists from other disciplines within Research and as such, promote a culture that embraces open scientific debate and agile, accountable decision-making.

Kræftens BekæmpelsePhD fellowship in nutrition and epidemiology – nitrate and risk of non-communicable diseases

Kræftens Bekæmpelse, Copenhagen

We are looking for a highly motivated PhD fellow to join the Nutrition and Biomarker research group at the Danish Cancer Society Research Center (DCRC). DCRC is a cancer research institute within the Danish Cancer Society, with more than 250 researchers from 25 countries.

The successful candidate will join a project that investigates the association between source-specific nitrate and risk of non-communicable diseases. Nitrate is a controversial component of vegetables, meat, and drinking water. Health beneficial effects are observed for cardiovascular diseases, whereas a concern about a link between nitrate ingestion and cancer has been raised.

The project is conducted in collaboration with Aarhus University, Geological Survey of Denmark and Greenland (GEUS) and Edith Cowan University (Australia).

Chr. Hansen A/SGlobal Senior Manager

Chr. Hansen A/S, Hvidovre

As our new Global Senior Manager for Global Technology Group you will be responsible for driving projects that improve our processes, prioritize production support and initiate improvements projects together with R&D.

Your organization will deliver production improvement through collaboration with the rest of Global Operations but also with Commercial Development and R&D.

You will:

  • Define best practice across production sites and drive process alignment
  • Be responsible for the fuel for growth initiatives within the global technology group
Chr. Hansen A/S
UnileverAre you Unilever’s new Product LifecycleTransformation Manager?

Unilever

The role is part of the Integrated Operations Program (iOPS) team which in an agile way is leading the Unilever Nordics business into the future.

In this role you will be leading the design of solutions that will improve how in Unilever Nordics we orchestrate the product cycle - from its launch to delisting. You will be involved in developments of leading-edge technologies and by this you will contribute to digital business transformation and implementation of smarter and more efficient ways of working when it comes to product lifecycle management., You will lead several initiatives and their implementations across all business functions, countries and product categories.

ALK
Drug Safety Advisor

ALK, Hørsholm

ALK, a global leader in allergy immunotherapy, is looking for 2 new colleagues in Safety Surveillance.

As a drug safety advisor, you will have plenty of responsibility, interdisciplinary collaboration, and stakeholder management. The overall responsibility of the drug safety advisor is to contribute to safety management throughout the product lifecycle in accordance with regulatory requirements and in collaboration with internal stakeholders.

Your responsibilities include

  • Performing scientific review of individual safety case reports
  • Performing signal detection and benefit-risk assessments
  • Writing periodic safety update reports
ALK
Bavarian Nordic A/S
TEKNIKER TIL ASEPTISK PRODUKTION

Bavarian Nordic A/S, Kvistgård

Har du lyst til at blive en del af et stærkt team og arbejde på en nybygget fabrik, med udstyr til sterilisation, fyldning, inspektion og pakning? Så søger vi en engageret tekniker, der har erfaring med og lyst til at arbejde aseptisk med færdigvare med hovedfokus på vaskemaskine og autoklaver.

Bavarian Nordic A/SVi søger teknikere til 3 holds skift – primært aftenskift for at kunne imødekomme vores produktion. Arbejdet vil primært være på vores fyldelinje, autoklaver og utensilie vaskemaskine og vil omfatte alt det udstyr vi bruger til produktion. Hvilket udstyr du kommer til at arbejde med, aftaler vi alt efter interesse og erfaring.

Bavarian Nordic A/S
Radiometer Medical ApS
Student assistant, project management, R&D, Immunoassay

Radiometer Medical ApS, Bronshoj

Here is your chance to use your structured approach to work as part of the project management of Radiometer Immunoassay. With your excellent organization skills, your structured and systematic work style to support key R&D projects and PMO organization skills, you will help drive project management excellence within our Immunoassay R&D organization

Hours: 7-15 hours a week depending on your schedule, exams and so on.
Starting time: 1st of August
Salary: Solid hourly pay based on your seniority in your studies + other benefits
Assignments: Assist project managers and the director of the PMO

Radiometer Medical ApS
Amgros I/S
Erfaren GDP-specialist til Indkøb og Forsyning

Amgros I/S, København

Vil du være med til at sikre, at de offentlige danske sygehuse har den rette medicin, til rette tid og i rette kvalitet? Altid med patienterne for øje og altid via tæt dialog og samarbejde? Så er det måske dig vi søger, da Amgros netop nu skal bruge en GDP-specialist.

SDS

Amgros sikrer forsyningen af lægemidler og høreapparater til de offentlige sygehuse og høreklinikker. Det gør vi via effektive indkøb og udbud. Vi står for at indkøbe og opretholde lager af lægemidler til de danske sygehuse – herunder også af et større lager af livsvigtige lægemidler.

Dine primære opgaver:

  • Ansvarlig for, at processer i IOF og Udbudsafdelingen lever op til GDP-lovgivningen
  • Registrere og håndtere tilbagekaldelser, afvigelser og reklamationer og sikre fremdrift på samme i IOF
  • Besvare GDP-relaterede henvendelser fra myndigheder, interessenter og samarbejdspartnere
Amgros I/S
ConvaTec, Infusion Care
Quality Compliance Engineer

ConvaTec, Infusion Care, Osted

Do you want to drive and develop risk management processes to ensure the transition to EU Medical Devices Regulation (MDR) for our entire product portfolio? Do you want to join a world leading company specialized in treatment of chronic diseases such as Diabetes and Parkinson’s Disease? Then you might be our new Quality Compliance Engineer.

You will be responsible for ensuring that procedures and instructions for project documentation fulfills internal and external requirements and are compliant with international regulations. Furthermore, you will generate and approve documentation for projects run by our Mexican and Danish organization.

Your main responsibilities includes:

  • Responsibility for risk management processes in collaboration with other Quality Compliance Engineers
  • Support audits and inspections and follow up for these
  • Responsible for procedures, instructions and templates mainly in the risk management area
ConvaTec, Infusion Care
Arla Foods amba
Projektleder til optimeringsprojekter / PTD Project Lead, HOCO - Holstebro

Arla Foods amba

Er du klar til at være den drivende kraft i udviklingsprojekter på udvinding af ingredienser fra mælken? Bliv en del af Arla Foods HOCO, en højteknologisk virksomhed, som en af verdens førende producenter af højtforædlede mælkeproteiner og mineraler.

Det er vores vision at styrke ”skelettet” i vores virksomhed. Som NPD projektleder vil du få en bred berøringsflade hvor optimeringsprojekter vil fylde din hverdag. Som ansvarlig for optimering og projekter, vil du:

  • sikre korrekt implementering af nye produkter i produktionen
  • være bindeled mellem QEHS, Produktion og kommercielle interessenter, samt supportere disse i produktrelaterede spørgsmål
Arla Foods amba
LEO Pharma
Regulatory Affairs Senior Professional - CMC Device

LEO Pharma, Ballerup

As Regulatory Professional you will represent Global RA with respect to the device constituent part of drug-device combination products. You will be responsible for the strategic regulatory input and to drive the regulatory activities for new and established products. We are working closely with RA CMC and R&D in relevant cross organizational project teams. Here, you ensure the regulatory device deliverables to the device technical file, Module 3, clinical trial applications, and other meeting packages to Health Authorities according to agreed timelines.

LeoPharma

As senior professional you will assume the role to guide and set direction within the drug-device combination product area to find the best solutions as far as compliance and how to work across in the organization.

LEO Pharma
LEO Pharma
R&D Quality Expert within CMC and Devices

LEO Pharma, Ballerup

Would you like to help us bring new treatments to patients with skin conditions world-wide? Would you like to play a key role in driving GxP compliance for CMC and Devices in support of LEO Pharma’s growing R&D pipeline? Are you looking for a job where you can use your large Quality insight and impact the quality processes of a growing VP Area? Then this is the job for you!

LeoPharma

You will be part of the newly established CMC & Device Project Management and Business Support organisation where you will work in close collaboration with line of business stakeholders in the CMC Design & Development VP Area. Together you will ensure that LEO Pharma’s quality processes and capabilities are maintained and in line with health authority expectations and industry best practice.

LEO Pharma
LEO Pharma
Professional - Regulatory Processes & Compliance

LEO Pharma, Ballerup

LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner – and that is why we need you. In Global Regulatory Affairs, we are changing our operating model, introducing a new global partner and simplifying our quality framework in a global set up. This is where you enter the scene with all of your quality mindset.

Securing and supporting a quality setup that is easy to use and easy to maintain and thereby facilitate compliance across Global Regulatory Affairs.

LeoPharma

Your primary tasks will be:

  • Develop & Maintain Regulatory Training Matrix
  • Manage Changes, Deviations and Non-Conformities including CAPA handling
  • Manage GxP Supplier list
LEO Pharma
Mediq Danmark A/S
Associate Category Manager, Nordics, Baltics & UK

Mediq Danmark A/S, Brøndby

Ready to shape tomorrow’s healthcare? We are looking for someone who wants to make a difference! The Category Management & Sourcing team is a core part of the Mediq value chain with responsibility for ensuring a competitive and differentiated product portfolio via establishment and maintenance of supplier partnerships.

As Associate Category Manager in Category Management & Sourcing, Nordics & Baltics you will be responsible for supporting the strategic direction of your category securing a competitive assortment for selected customer segments across Nordic & Baltics and in collaboration with the Category Manager, develop and implement sourcing projects across all business areas and business units.

You will be a central part of the largest pan-Nordic category Personal Protection Equipment (PPE) and Nursing & Facility and be involved in supplier identification over negotiation to supplier management.

Mediq Danmark A/S
AJ Vaccines A/SEM Professional

AJ Vaccines A/S, Copenhagen

We are looking for an academic employee experienced within GMP and Environmental Monitoring (EM) to ensure the right level of controlled environmental conditions according to GMP and the best possible processes within the environmental monitoring area.

Release and GMP Support is a newly formed team of 13 in Polio Manufacturing department with the aim to support the GMP related topics and the release process. Your job as our Environmental Monitoring Professional will be to ensure that we comply with the current GMP regulations for EM while enabling a timely release of our products. Besides that, in a joined venture, we also expects you to contribute to the positive atmosphere and well-being in the team and a spirit where we help each other to reach the in-house goals.