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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.

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.

Junior QA Specialist søges

Motiveres du af at sikre et godt samspil mellem GMP compliance og den kommercielle drift?

Little Green Pharma er en international medicinsk cannabis virksomhed med hovedkontor i Australien. I vores topmoderne drivhuse i Odense og Perth har vi faciliteterne til at fremstille mere end 23 tons medicinsk cannabis biomasse om året, hvor størstedelen produceres i vores 21.500m2 drivhuse og vores 4.000m2 GMP godkendte produktions-lokaler i Odense, som vi har ambitioner om at vækste over de kommende år til at opnå fuld udnyttelse.

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.

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.

Health, Safety and Environment (HSE) Manager

Are you a seasoned Health & Safety professional seeking an opportunity to thrive in a supportive and dynamic environment?

We have an exciting opportunity to recruit a Health & Safety Manager, you will play a crucial role in maintaining and enhancing the safety standards at our facility. Your responsibilities will include designing training programs, conducting risk assessments, identifying, and controlling hazards.

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

QA Specialist med GMP-erfaring

Vi søger vi en erfaren og selvstændig QA Specialist, der har lysten til at være en del af udviklingen af en nystartet state-of-the-art-bioethanol-produktionsvirksomhed.

Dine primære arbejdsopgaver vil være:

• Vedligeholdelse af QMS-system, instruktioner, vejledninger osv.
• Review af batchdokumentation.

Du tilbydes en attraktiv og konkurrencedygtig lønpakke med pension og sundhedsforsikring.

Teamleder til inspektion af engrosforhandlere og private apoteker

Vil du stå i spidsen for et dynamisk team og være med til at sikre GDP-compliance ved myndighedsinspektioner i Danmark?

Din rolle som leder bliver at bevare det gode og tværfaglige arbejdsmiljø, og bidrage til at gennemføre Lægemiddelstyrelsens strategi i praksis ved motiverende ledelse af dit team.

Dine primære arbejdsopgaver:

• Personaleledelse af teamet, herunder sikre god start og inkluderende træning for nye og nyere inspektører, og bidrage til at skabe gode rammer for teamet.
• Sikre teamets leverancer, tværgående samarbejde, samt udvikling, herunder prioritering, målstyring og koordinering på tværs af teams.

Utility Engineer

Er du klar til at blive en del af en innovativ, international vaccinevirksomhed, som den tekniske specialist?

I rollen vil dine primære arbejdsopgaver være support til teknikere og brugere, herunder hjælp til fejlsøgning på anlæg og udstyr, samt at sikre:

• Robusthed af anlæg ved kontinuerligt at have styr på vedligehold
• At GMP og regulatoriske krav er overholdt

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.

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 Supplier Quality Engineer

This is a key role within the Global Quality function, where you will have the objective of supporting the maintenance and improvement of ConvaTec’s Global Supplier Quality program and conducting supplier audits to ensure compliance.

Key Duties & Responsibilities

• Support and lead where appropriate, supplier selection, evaluation, and approval.
• Generate appropriate key performance indicators to assess supplier.
• Drive resolution of corrective actions.

Filialleder

Søger du nye udfordringer, er der en spændende og alsidig stilling ledig på Ejby Apotek.

Vores mangeårige filialleder har søgt nye udfordringer og vi søger en erstatning for hende.

Ansvarsområderne er:

• Daglig ledelse af filialen
• Løbende optimering af varespejlet i selvvalget og butikkens fremtoning generelt
• Salgsfremmende aktiviteter

QA Specialist og Senior QA Specialist

For dig, der trives med at arbejde med kvalitet og lovgivning fra et operationelt perspektiv, både selvstændigt og i dialog med vores leverandører og interne afdelinger.

Som QA Specialist vil du være det koordinerende bindeled mellem de forskellige teams i QA, regulatorisk og Pharmacovigilance i relation til udfærdigelse eller opdatering af eksisterende TA.

Technical Writer to GE HealthCare Denmark

Join GE HealthCare to help develop high quality instructions for use for our ultrasound scanners, transducers, and reprocessing methods in compliance with rules and legislation in various countries. This is your opportunity to become part of an innovative team where your work has a real impact on people’s lives around the world.

Our Technical Documentation team consists of six dedicated and passionate specialists with a mix of seniority, educational backgrounds, and nationalities. Our Technical Writers develop and maintain the user documentation for our high-performance equipment.

QA Specialist

You will be responsible for ensuring safe, reliable, and compliant products during new product development and maintenance of existing product platforms.

You will have the opportunity to:

• Provide Design Control guidance for QMS and regulatory compliance in an FDA regulated and ISO compliant environment.
• Represent Quality Assurance in design and development projects and in cross-functional teams supporting new product development.

Projektleder

Din opgave bliver at være projektleder for etablering af et procesanlæg til kaffeproduktion. Anlægget kommer til at bestå af lagerstyring af rå- og færdigvarer, sortering af bønner, ristning med flere forskellige størrelse ristere, køling, formaling og pakning på to forskellige pakkelinjer.

Det er vigtigt, at du har forståelse for den snitflade, projektet har til NEXTs kerneopgave – at uddanne selvstændige og fagligt kompetente procesoperatører.