Opportunité Professionnelle au Danemark
Quality Assurance Specialist in Drug Product Manufacturing
Entreprise : Fujifilm
Localisation : Hillerød, Hovedstaden
Date de l’annonce : 09 juillet 2025
Fujifilm, un leader mondial dans le développement et la fabrication de biologiques à façon, recherche un *Quality Assurance Specialist* pour se joindre à son équipe à Hillerød, au Danemark. Cette opportunité s’inscrit dans un environnement dynamique où l’innovation et la qualité occupent une place prépondérante.
Description du poste
Le candidat idéal possédera une expertise dans la revue et l’approbation d’incidents, ainsi que dans la gestion des mesures correctives et préventives (CAPA) pour garantir des normes de qualité élevées. Les principales responsabilités incluent :
- Supervision QA pour les simulations de processus aseptiques.
- Vérifications de conformité à travers des marches qualité.
- Conduite de projets d’amélioration dirigés par l’assurance qualité.
- Support dans le projet de transfert technologique pour l’introduction de nouveaux produits.
- Revue et approbation des dossiers de production.
- Évaluation des analyses de risques.
- Approbation des alarmes des installations.
- Préparation pour les inspections et participation aux audits partenaires.
- Collaboration avec d’autres départements sur différentes initiatives.
- Approbation des plans d’entretien des équipements et protocoles de validation.
Compétences et qualifications requises
Pour postuler, les candidats doivent posséder un ensemble de qualifications comprenant :
- Diplôme de Master en pharmacie, ingénierie chimique ou un domaine connexe.
- Un minimum de 5 ans d’expérience dans un rôle QA au sein de l’industrie pharmaceutique.
- Expérience avec les processus de remplissage et d’inspection visuelle ainsi que la production aseptique.
- Maîtrise de l’anglais, à l’oral comme à l’écrit.
- Connaissance des processus de qualification d’équipement est un atout.
- Bonne connaissance des directives GxP et des systèmes de qualité.
Équipe et environnement de travail
L’équipe de QA des Produits Médicamenteux chez Fujifilm se compose actuellement de sept membres. Ce groupe est en pleine phase de formation, se concentrant sur l’établissement de valeurs de qualité et la définition des processus nécessaires au fonctionnement des nouveaux rôles opérationnels de QA.
L’environnement de travail est international, informel, et valorise l’équilibre entre vie professionnelle et personnelle. Fujifilm promeut la sécurité psychologique à travers la confiance et l’autonomisation au sein de ses équipes.
Processus de candidature
Les candidats intéressés sont invités à soumettre leur CV et une lettre de motivation dans les plus brefs délais. Les interviews seront organisées de manière continue, et l’annonce sera retirée une fois le candidat idéal identifié. Pour toute question, il est possible de contacter Maria Louise Olsen, la responsable de la QA des Produits Médicamenteux.
Fujifilm Biotechnologies valorise la diversité et l’inclusion. Toutes les candidatures seront prises en considération sans distinction de race, couleur, religion, sexe, origine nationale, handicap, orientation sexuelle ou toute autre catégorie protégée.
📅 Date de publication de l’offre : Wed, 09 Jul 2025 02:53:41 GMT
🏢 Entreprise : Fujifilm
📍 Lieu : Hillerød, Hovedstaden
💼 Intitulé du poste : Quality Assurance Specialist in Drug Product Manufacturing
💶 Rémunération proposée :
📝 Description du poste : Are you skilled at reviewing and approving incidents, CAPAs, and change management records to maintain high standards of quality?And would you like to support QA in tech transfer project for bringing newproducts from existing or new customers?Then we really hope you are our new colleague!Your New RoleYou will handle daily quality issues and support optimizations within the production. Your responsibilities will beside core QA tasks include supporting to tech transfer projects. Additionally, you’ll work on optimization projects and help address any areas where QA support is needed.We value adaptability, allowing tasks to align with your interests and experience whether this lays within batch review and release or quality approval of validation documentation.Your key responsibilities could include:
- Provide QA oversight for Aseptic Process Simulations.
- Conduct quality walks to ensure compliance.
- Drive QA-led enhancement projects and support other projects driven by other departments.
- QA support in tech transfer project for bringing new products from existing or new customers.
- Review and approve Batch Production Records.
- Review and approve Risk Assessments.
- Approve Facility alarms.
- Support inspection readiness and participate in partner audits.
- Drive QA-led enhancement projects and collaborate on cross-department initiatives.
- QA approval of equipment maintenance plans and validation protocols.
Your Skills & Knowledge
- Master’s degree in pharmacy, chemical engineering, or a related field.
- Minimum of 5 years’ experience in a QA role within the pharmaceutical industry.
- Experience with filling and/or visual inspection processes and aseptic production.
- Proficiency in English, both spoken and written.
- We also positively evaluate profile with knowledge of equipment qualification processes
- Well-versed in GxP guidelines and quality systems knowledge.
We Hope You AreA team player with a can-do attitude and lots of collaborate energy while thriving in a changing environment.Your New TeamOur Drug Product QA team currently consists of seven team members and is part of the QA organization, reporting to the Associate Director for Drug Product & Finished Goods.We are in a formative stage, establishing our quality values and defining processes as we transition into new DP QA operational roles.As we embark on this journey, team members are energized by bringing processes under control and adapting to our start-up phase. We prioritize high-quality standards and GMP compliance through close collaboration with our stakeholders.Our team is engaged in both DP QA operational activities and the QA approval of equipment, utility, and facility validation documentation.We work with international QA teams for, ensuring a proactive and cooperative approach across all initiatives. Joining us means contributing to a dynamic and evolving environment where your impact on quality assurance is both valued and essential.The work environment is international and informal. We keep a high pace and focus on a vital life balance while having fun. We put a strong emphasis on psychological safety through trust and empowerment within our teams and hope that this is something that speaks to you as well.Your applicationDoes this sound interesting? Then please upload your CV and cover letter as soon as possible, as we will continuously invite relevant candidates for job interviews. The job advertisement will be removed when the right candidate has been identified.If you have any questions, feel free to contact our DP QA Manager, Maria Louise Olsen, at .Even if you don’t meet all the criteria but believe you can contribute meaningfully to our team, we encourage you to apply.FUJIFILM Biotechnologies is a global leader in biologics contract development and manufacturing Organization (CDMO), partnering with innovative biotech and biopharma companies to transform healthcare. With locations in Denmark, the UK, and the USA, we support every stage of our customers’ product lifecycle, from breakthrough cures to life-saving vaccines.Our success starts with our people—their passion drives progress, innovation, and impact. Join a diverse, inclusive workplace that values collaboration, fosters growth, and empowers future generations. Together, we’re enriching communities, protecting the environment, and reimagining healthcare’s potential.Shape the future with us—your drive meets boundless opportunity hereFUJIFILM Biotechnologies Denmark is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identify or any other protected class.To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid
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