35 jobannoncer matcher din søgning 35 jobannoncer fundet

Senior Compliance Professional

Do you have a broad experience with compliance-related matters within root cause investigations and systematic problem-solving in a pharmaceutical Engineering or Manufacturing organization?

You will participate in improving our systematic problem-solving skills and systems to prevent recurrent deviations and deliver compliance support for the Utility-, Metrology-, Maintenance- and Automation- specialists.

You will be part of a team with a focus on well-being, and achieving our goals, and where there is room to have fun along the way.

Specialist til API-produktion i København - Vær med, når vi redder liv

Du vil lede root cause-analyser, koordinere kvalitetsopgaver, være ansvarlig for kvalificeringer/valideringer af procesændringer, følge op på produktionsdata samt overvåge processerne. Arbejdet foregår i tæt samarbejde med kvalitetsafdelingen og den tekniske afdeling. Du vil ligeledes opleve operatører, teknikere, specialister og API-ledelsen som vigtige interessenter.

I stillingen vil dit primære ansvar og dine opgaver være:

• teknisk sparring og processupport til produktionen
• håndtering af kvalitetssager

Chemical Engineer – build pilot plants to create green ammonia

2% of the global CO₂ emissions originate from ammonia production. Do you also think that is 2% too much? And do you want to be the mastermind behind the pilot plants that will let us scale up our prototype to a demonstration unit?

Then join us and get your daily dose of entrepreneurial startup spirit while enjoying flexible working hours.

Coop Trading is looking for a technical expert to handle cosmetics and personal care products

Do you have a technical background within chemistry or pharmacy, and are you curious by nature to learn more, e.g. about developing products for retail?

You will develop an attractive and competitive personal care and cosmetic product portfolio for the Nordic Private Brand market in close cooperation with the team and suppliers. You wil also quality assure that the portfolio complies with Coop's high standards within safety, sustainability, consumer information and quality.

HSE Specialist

As an HSE Specialist, you will have the opportunity to develop and implement safety policies and procedures, conduct training sessions, and ensure compliance with local, state, and federal regulations.

In joining our team, you'll have the opportunity to make a significant impact, ensuring the safety and well-being of our workforce while contributing to our continued success at Duferco Danish Steel.

Seniorbæredygtighedskonsulent med fokus på klima og miljø

Har du erfaring med bæredygtighed, klimaaftryk og LCA-analyser?

Du kan se frem til at få en nøglerolle i at realisere vores klimahandlingsplan og er bl.a. med til at udvikle vores tilgang til at dokumentere og reducere klimapåvirkningen fra vores anlægsprojekter.

Dine nærmeste kolleger er afdelingens fem bæredygtighedskonsulenter, der med forskellige baggrunde inden for bl.a. klima, miljø, biodiversitet, menneskerettigheder og bæredygtighed driver indsatser og støtter bredt op om organisationens arbejde.

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.

Senior Regulatory Affairs Manager

This pivotal role will involve navigating the complex regulatory landscape associated with technologies for the production of hydrogen, its derivatives and other related technologies. This critical role will also involve ensuring compliance and strategically influencing regulatory development to support our mission.

The ideal candidate will have a deep understanding of energy regulations, a passion for sustainability, and the expertise to guide our company through the evolving regulatory environment.

QA Specialist for Environmental Support

In this role, you will join Bavarian Nordic's QA Organization as a QA Specialist tasked with establishing strong relationships with stakeholders, effectively communicating GxP requirements, and handling crucial Quality Events in the Quality Management System (QMS).

This is in the context of environmental monitoring, aseptic performance, and sterile & low bioburden processes in Drug Substance and Drug Product Production. Additionally, you will contribute to the ongoing improvement of QA processes to elevate overall quality standards.

2 Regulatory and Marketing Compliance Managers

Har du interesse for og meget gerne erfaring med Regulatory Affairs – og helt optimalt med Marketing Compliance – og vil du gerne arbejde mere målrettet med Marketing Compliance?

Dine arbejdsopgaver bliver bl.a.:

• Compliance review af marketingaktiviteter og -materialer for den farmaceutiske industri og anmeldelser til Etisk Nævn for Lægemiddelindustrien
• Oversættelser af regulatoriske og medicinske dokumenter (dansk/engelsk)
• Andre regulatoriske opgaver svarende til opgaverne i et dansk datterselskab: gennemgang og opdatering af produktinformation, regulatorisk review af artwork m.v.

Manufacturing Support Documentation Associate

Do you have a flair for compliance and can handle many stakeholders? Are you looking for a position where you can take on responsibility?

About the position:

• Create and maintain records and procedures by collecting information from stakeholders to supply manufacturing with compliant documents.
• Start-up events and support investigations by giving input as procedural SME.
• Support the change process by writing SME assessment to ensure procedural alignment. Perform timely closure of action items to ensure reliable execution of production.
• Continuously improve the department processes and support stakeholder improvement projects.

Produkt- og reguleringsansvarlig / PSRA-officer

Er du klar til at påtage dig en vigtig rolle i udvikling og implementering af den regulatoriske strategi for Bostik og LIP Nordic, der er førende producent af byggematerialer i Norden?

Vi stræber efter at skabe en innovativ og fremsynet arbejdsplads hvor dine idéer kan blive til virkelighed.

Som PSRA Officer er du i frontlinjen af den regulatoriske strategi. Ansvarsområderne inkluderer at produkterne sikrer fuld overholdelse af både dansk- og EU-lovgivning samt overholdelse af krav om miljø og andre regulatoriske regler og sikre at dokumentation har compliance til de højeste standarder.

QA Ext. Manufacturing Specialist

Would you like to work in one of the most interesting, complex, and dynamic areas in Bavarian Nordic? Are you ready to engage, support, and mobilize colleagues in a growing international business environment where we focus on saving lives every day?

As a QA Specialist, you will be responsible for daily support, QA oversight, and GMP guidance to Contract Manufacturing Organizations (CMOs) to ensure that our products are manufactured according to current GMP and our marketing authorizations.

Equipment Professional – Wash and Sterilization, Freeze dryer

Kunne du tænke dig at blive en del af et stærkt team og arbejde på en nybygget fabrik, med udstyr til sterilisation, frysetørring, fyldning, inspektion og pakning? Du vil komme til at understøtte den nuværende udstyrsansvarlige, som vil sørge for den nødvendige oplæring.

Du vil blive en del Technical Support og vil være tilknyttet området for autoklaver, vaskemaskiner og vores frysetørrer. Her vil du være med til at sikre proces, procedurer, GMP, og generelle forbedringer på udstyret.

Product Certification Specialist

Brænder du for at arbejde med certificering inden for brand og sikring, så har du nu muligheden for at træde ind i en verden af specialister med den fælles mission af sikre liv og værdier

En stadigt stigende markedsefterspørgsel har sendt DBI Certifications A/S på en vækst- og udviklingsrejse, da markedet og kunderne efterspørger DBI Certifications kompetencer og ydelser ift. certificering af produkter, produktioner, virksomheder og personer inden for brand og sikring. Vi søger derfor en ambitiøs og dygtig Product Certification Specialist, der via certificering i forhold til lovgivning, standarder og retningslinjer, skal være med til at bane vejen for kundernes adgang til markedet.

Kvalitetschef

I forlængelse af en øget internationalisering ønsker vores kunde at tilføre organisationen en kompetent kvalitetschef, som får det daglige ansvar for kvalitetsarbejdet og systemet på fabrikken.

Der er tale om en særdeles velkonsolideret virksomhed med høje kvalitetsstandarder og certificeringer. Den nye kvalitetschef vil referere ind i udviklingsorganisationen.

Dagligdagen vil indeholde alle aspekter af kvalitetsarbejde, heriblandt:

• At være ansvarlig for kvaliteten af produkterne samt virksomhedens compliance med lovgivning og relevante ISO-standarder
• At håndtere og vurdere afvigelser
• At være sparringspartner for produktionen i kvalitetsmæssige spørgsmål

Senior QA Specialist

You will be part of our QA Business Support Team, consisting of 12 QA Specialists and Senior QA Specialists, allocated to projects including innovation projects, capacity projects and strategic QA/QC projects. We participate in projects both as quality and compliance experts to ensure compliance with the requirements for Class III Medical Devices.

We are driven by improving patient outcomes and we take our values to work every day – we care about each other, our environment and our customers and we win for patients with innovative high-quality solutions.

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.