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AlfaNordic A/S, Herlev
Er du nyuddannet og interesseret i en karriere indenfor life science-branchen? Har du interesse indenfor it/automatik eller projektledelse, så tilmeld dig åbent hus-arrangement hos AlfaNordic den 29. maj.
Pharma Academy er en lønnet uddannelse hos AlfaNordic Academy A/S, der henvender sig til unge ambitiøse og dedikerede nyuddannede med lyst til at arbejde i farmabranchen. Uddannelsen er en ekstraordinær mulighed for at få unikt indblik i branchen, samt opbygge de nødvendige kompetencer og få bred erfaring på kort tid.
AlfaNordic Academy A/S har i samarbejde med farmaindustrien og ledende institutioner i Danmark udviklet graduate-programmet Pharma Academy, der strækker sig over 2 år, hvor du arbejder ude i en farmavirksomhed fra dag ét. Du modtager undervisning sideløbende med ‘hands-on jobtræning’. Efterfølgende er der mulighed for fastansættelse i virksomheden eller job som konsulent hos AlfaNordic.
LEO Pharma, Ballerup
If you have a solid understanding of guidelines across EMA/ICH/FDA, and you are looking for a job with great variety of tasks and global vision, you don’t have to look any further. At LEO you will be part of a successful and rapidly growing company, and you will join a well-functioning department known for team spirit, cooperation and genuine care for each other.
As Senior Pharmacovigilance Specialist your primary focus is to make sure that overall processes are maintained and optimised in order to submit/distribute case reports according to PV legislation and maintain a high compliance in relation to legislation worldwide. In overview your primary tasks will be to:
- Surveillance of outsourcing partner
- Maintain quality documents and processes (both for post marketing and clinical trials)
- SAE reconciliation and reconciliation of cases with affiliates and partners
AGC Biologics A/S, Søborg
QA Operations is looking for an experienced Director to assist with daily management of the Department and facilitate quality oversight and general compliance during manufacturing activities and batch release of biological intermediates and APIs for commercial / clinical trials.
As QA Operation Director, you will be involved in various daily operational tasks in a dynamic and challenging environment. The team handles review and approval of quality documentation e.g. Batch Production Records, Master Production Records, Specifications, QC analytical procedures, QC stability documentation, validation processes (PPQ manufacturing process and QC analytical method validations), Change Requests, Deviations and CAPAs.
Do you see a bright future in digital healthcare ahead?
Do you want to be part of our great team developing next generation of high quality products including hearing solutions, apps and cloud services, then do not stop reading…!
In your role, we make way for you to take responsibility to make sure that our SW-products fulfil the user’s expectations as well as the regulatory requirements. Your daily work will be supported by state-of-the-art methods, equipment and laboratories. To support the business and organization globally, you can expect 10-15 days/year of travelling.
We will provide you with a wide portfolio of interesting and challenging tasks, in which your main focus will be among others:
- Plan and execute activities related to quality assurance of software products being developed.
- Participate in milestone reviews and provide input from Quality.
- Quality & compliance risk assessment for open defects related to SW.
Kevin Murphy Europe A/S, Copenhagen
Reporting to the Global Director of Procurement, the Global Regulatory Affairs Manager will be responsible for leading activities of the Regulatory Affairs Department with an emphasis on global regulatory strategy and the preparation, review and submission of documents to any regulatory authorities at a global level.
Oversees the regulation process for products requiring governmental approval, including filing necessary applications and handling all government interactions in the geographical areas where KEVIN.MURPHY Group products are marketed. Coordinates inspection of the organization and contract facilities and develops procedures to ensure regulatory compliance. Requires a Master's degree in the area of specialty.
Symphogen A/S, Ballerup
The position as Team Manager for our Analytical Development team offers a unique possibility to take part in development of Symphogen’s antibody products. We are looking for a candidate with a strong leadership profile to head a team of skilled and dynamic scientists, and to provide input to Symphogens overall CMC development strategies.
The Analytical Development team is responsible for analytical development and validation, tech transfer of analytical methods to external QC function, development of specifications, reference strategy as well as the overall analytical control strategy.
As Team Manager for Symphogen’s analytical coordinators and analy-tical development scientists you will work in close collaboration with our CMC project directors and project groups.
Symphogen A/S, Ballerup
The position as senior scientist within pharmaceutical development and stability offers a unique possibility to take part in development of Symphogen’s antibody products.
You will collaborate closely with staff from our CMC group and in project teams, to ensure development progress of Symphogen’s antibody lead candidates. You will also work with our external CMOs with regards to e.g. compatibility studies and stability studies.
The position is anchored in the Team Stability and Formulation in Department of Analytics and Formulation within CMC. The team is responsible for formulation development, stability studies for drug substances and drug products and for pharmaceutical development of drug products.
Regulatory CMC & Drug/Device Specialist
Zealand Pharma A/S, Glostrup
Zealand Pharma A/S (Zealand) is seeking a Regulatory CMC and drug-device specialist who will be responsible for Regulatory CMC and device tasks related to our development projects.
The successful candidate will:
- Be an experienced and proactive Regulatory CMC expert with late stage drug and drug-device development experience who can enable our fast to patient strategy through close liaison with our pharmaceutical development and commercial manufacturing departments
- As part of the CMC project teams find the best regulatory strategy and pathways for CMC plans and know the potential shortcuts and pitfalls
- Advice on regulatory and non-CMC consequences of CMC/device decisions.
Clinical Trial Administrator
Zealand Pharma A/S, Glostrup
Zealand Pharma A/S is seeking an experienced Clinical Trial Administrator to the Clinical Operations department. The department is responsible for setting up, overseeing and directing clinical trials from early development phases to market approval, typically with the use of and collaboration with Clinical Research Organizations (CROs).
The department is part of Clinical Development and is composed of a dynamic team with enthusiastic and professional colleagues. We have an open and respectful working environment with great team spirit and high quality mind-set, encouraging knowledge sharing and development of people and processes.
Due to the increased number of new trials to be initiated, we are seeking a new experienced colleague to join our team.
Nordic Sugar A/S, Copenhagen
Are you experienced working with product quality & safety and as an auditor? Are you passionate about quality? Do you dream about a job with responsibility and a high level of interaction with people across different cultures? Then you may be our new colleague joining Nordic Sugar, part of the Nordzucker Group.
You have to perform a number of diverse tasks in the field of corporate SHEQ (Safety, Health, Environment and Quality).
Your primary tasks and areas of work are:
- Ensure development and implementation of product quality and safety (PQ&S) policy in the food and feed areas
- Develop and implement product quality and safety measures on group level
- Heading the internal PQ&S (HACCP) group
LEO Pharma, Ballerup
LEO Pharma has set out to become the world’s leading dermatology care partner. Part of fulfilling this very ambitious goal is founded on our ability to take our medical device operation to the next level. And that is why we need you. If you bring quality system expertise within medical devices and you are looking for an opportunity to unfold all of your skills in a wider context, this exciting job is just what you want.
You will become key driver of anchoring all medical device related requirements in our global QMS. At the same time you will handle other quality tasks in order to create and implement smart and business focused global processes – to ensure your development and to benefit from your knowledge. We expect a 70/30 split between device related and more general improvement initiatives.
The new QC Director will report to the Vice President of Quality. The QC laboratory consists of 50+ employees organized in 3 departments, QC Bioassay, QC Chemistry and QC Microbiology. Each department is headed by a Manager and Team Leads. Besides daily lead of direct reports and general management of QC activities, the QC Director will participate in strategic initiatives and customer meetings.
Main purpose of the position
- Direct staff and operations within Quality Control in accordance with cGMP regulations and AGC Biologics standards.
- Establish strategic goals and objectives and maintain full strategic responsibility for Quality Control.
- Provide leadership and guidance to immediate staff performing Quality Control activities.
Jobindex A/S søger for Particle Measuring Systems i Greve
Brug din bioanalytiske viden og dine rådgivningsevner i en førende, international virksomhed inden for partikeltællere til pharma- og biotech-industrien. Her kan du udnytte dit salgstalent til at skabe succes sammen med et stærkt team af kolleger, der står klar med god opbakning.
Particle Measuring Systems er i en rivende udvikling, og da vi har et stigende antal ordrer, udvider vi nu med en ekstra Sales Account Specialist. Vil du med på holdet?
Som vores nye Sales Account Specialist udvikler du salget til nye og eksisterende kunder i Danmark, men også i mindre grad til Sverige, Norge og Finland. Her får du ansvar for hele salgsprocessen fra den første kontakt, rådgivning og produktinstallation til lukning af salget.
Unomedical A/S, Osted
Til vores virksomhed Unomedical Infusion Care, søger vi en regulatorisk specialist til vores RA-team i Osted, ca. 40 kilometers kørsel fra København.
Vores regulatoriske specialister varetager internationale opgaver i forbindelse med registrering og salg af vores produkter verden over. Det regulatoriske team består i dag af 3 regulatoriske specialister og en regulatorisk assistent. Arbejdsmiljøet er præget af en uformel tone med stor indflydelse på planlægning og udførelse af eget arbejde.
- Review/godkendelse af markedsføringsmateriale og pakkemateriale
- Review/godkendelse af ændringer til eksisterende produkter (Change Control)
- Registreringer af vores eksisterende produkter for eksisterende samt nye kunde.
3Shape A/S, Copenhagen
3Shape is looking for Product Quality Engineer to strengthen the quality assurance in our TRIOS Intraoral Scanner program.
You will get strongly involved in all phases of the product development life cycle in an agile development organization, of the multiple award-winning 3Shape TRIOS Intraoral Scanner.
Your job is to ensure that our TRIOS Intraoral Scanners are developed according to 3Sshape QMS and regulatory standards and of course in a high quality.
The 3Shape R&D organization is rapidly expanding, and so are our requirements for ensuring that quality is well integrated into our development process. We continually strive to optimize the approach to quality assurance, while bringing high quality and innovative products faster to the market.
Har du lyst til at arbejde med højteknologi og det nyeste udstyr? Kan du holde hovedet koldt i hektiske situationer? Og vil du gerne aktivt deltage i projektarbejdet sammen med udviklingsingeniørerne? Så har vi en spændende mulighed til dig i Oticon/DGS.
DGS i Ballerup er en del af William Demant-gruppen, der bl.a. udvikler og producerer Oticon-høreapparater. Vi søger netop nu en produktionstekniker med teknisk flair, som har lyst til at arbejde med vores højteknologiske produktionsudstyr og udvikle sin karriere i en anerkendt, international og førende virksomhed inden for udvikling af avancerede høreløsninger.
Dine opgaver vil være:
- Programmering af produktionsudstyr
- Vedligehold af produktionsudstyr
- Træning og uddannelse af operatører.
Radiometer Medical ApS, Brønshøj
We are proud of our focus and dedication to quality in Radiometer. We have a healthy focus on continually improving our way of working with quality documentation and we believe you will enjoy helping us develop even further in this area.
You report to the Director for Global QMS and your new team consists of you and 3 other QA Specialist. Besides your own team the QMS Compliance department also has a Customer Complaint Team with 6 people.
Your main responsibility is to drive optimization of the Quality Management System and support the organization locally as well as globally. You can expect to work with:
- Maintaining and supporting optimization of the Quality Management System.
- Sharing knowledge and maintaining expertise within applicable standards and regulations.
Unomedical A/S, Osted
Vi søger en Product Quality Engineer med solid QA/RA-erfaring til vores virksomhed Unomedical Infusion Care, a ConvaTec Company i Osted, syd for Roskilde.
Trives du med varierende og udfordrende projekter og opgaver inden for risikovurdering, designkontrol, procesvalidering, og dokumentation? Så er jobbet som Product Quality Engineer måske noget for dig.
Som Product Quality Engineer vil du som ”one point of contact” være kvalitetsafdelingens repræsentant i forskellige af virksomhedens projekter og være ansvarlig for, at alt projektdokumentation er i compliance med såvel interne som eksterne krav, for at sikre indhentning af FDA-godkendelser og vedligehold af CE-mærkningen. Du bliver del af et team på 9 Product Quality Engineers/QA validation Engineers med reference til Associate Director for Product Quality Engineering.
Department of Pharmacy at the Faculty of Health and Medical Sciences University of Copenhagen seeks two Assistant Lectures for employment...
Københavns Universitet, København Ø