Responsable Assurance Qualité Produit et Distribution- PRI at Fresenius Medical Care

Fresnes, Ile-de-France, France

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, Medical DevicesIndustries

Requirements

Diplôme universitaire en pharmacie avec spécialisation en Assurance Qualité
Inscription en section B de l’Ordre des Pharmaciens en tant que Pharmacien Responsable Intérimaire (PRI)
Minimum 5 ans d’expérience dans des fonctions similaires en assurance qualité et distribution pharmaceutique
Maîtrise des référentiels qualité (BPD, ISO, vigilance), des outils bureautiques et logiciels qualité
Rigueur, autonomie, esprit d’analyse, excellente communication et sens du travail en équipe

Responsibilities

Assurer la conformité qualité des médicaments et dispositifs médicaux (normes nationales et internationales, BPD, etc.)
Identifier, prévenir et gérer les risques liés à la distribution : traçabilité, incidents, matériovigilance
Coordonner les rappels de produits, la gestion des retours, les réclamations qualité et la mise en œuvre des actions correctives et préventives (CAPA)
Assurer le lien avec les autorités de santé, notamment sur les sujets liés à la sécurité, à la qualité et à la continuité d’approvisionnement
Mettre à jour et suivre les documents qualité (quality agreements, procédures, rapports, plans de gestion des pénuries)
Participer aux audits internes, externes, et aux inspections des autorités
Réaliser des auto-inspections et audits de prestataires et distributeurs
Assurer la formation continue des équipes internes et des partenaires sur les exigences qualité

Skills

Assurance Qualité

BPD

ISO

CAPA

Matériovigilance

Audits

Pharmacovigilance

Regulatory Compliance

Quality Agreements

Product Recalls

Fresenius Medical Care

Provides dialysis and renal healthcare services

About Fresenius Medical Care

Fresenius Medical Care North America focuses on delivering high-quality healthcare services to individuals with kidney and other chronic conditions. The company operates a vast network of dialysis centers and outpatient labs for cardiac and vascular care, ensuring coordinated treatment for many patients across the continent. It stands out as the largest fully integrated renal company, providing not only dialysis services but also specialty pharmacy and laboratory services. Additionally, Fresenius manufactures and distributes a wide range of dialysis equipment, disposable products, and renal pharmaceuticals. The goal of Fresenius Medical Care is to enhance the quality of life for patients with chronic illnesses by providing comprehensive and accessible healthcare solutions.

Waltham, MassachusettsHeadquarters

1996Year Founded

$39.1MTotal Funding

LATE_VCCompany Stage

Biotechnology, HealthcareIndustries

11-50Employees

Benefits

Professional Development Budget

Conference Attendance Budget

Flexible Work Hours

Risks

Increased competition from telehealth solutions like Philips' eCareManager 4.1.

Rising mental health challenges may impact FMCNA's employee productivity.

Virtual reality education may face adoption and accessibility challenges in rural areas.

Differentiation

FMCNA is the world's largest fully integrated renal company.

FMCNA offers a comprehensive line of dialysis equipment and renal pharmaceuticals.

FMCNA provides coordinated healthcare services at pivotal care points for chronic conditions.

Upsides

Telehealth market growth supports FMCNA's remote patient monitoring services.

Home dialysis market expansion aligns with FMCNA's patient-centric care approach.

AI integration enhances FMCNA's predictive analytics and personalized medicine capabilities.

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