Quality Assurance

2 weeks ago

Laval, Canada Bausch Health Companies Full time

Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians.

Our team manufactures and markets a wide variety of pharmaceutical and health products that are distributed in pharmacies, healthcare practices and hospitals across the country.

At Bausch Health, we invest in our employees and we believe in the importance of cultivating performance and outdoing ourselves in finding new and better solutions with the aim of responding innovatively and effectively to current needs.

**Sommaire du poste (but, raison d’être du poste)**

Activités CMC:

- Fournit l’expertise règlementaire pour assurer la conformité réglementaire des produits fabriqués à l’usine
- Fournit le support technique en matière de dossiers réglementaires (CMC), contrôle des changements et conformité aux BPF
- Fournit l’expertise réglementaire et assurance-qualité pour la préparation de protocole de validation / stabilité et au besoin autre rapport technique

Activités Audits:

- Fournit l’expertise afin de soumettre la licence d’établissement des drogues et la licence de produits de santé naturels à Santé Canada
- Assure la mise en œuvre et le suivi des programmes d’audits internes et externes

**Fonctions principales**

**Activités Règlementaires-CMC**
- Assure, en collaboration avec le groupe des Affaires réglementaires Bausch Health et ceux des clients le suivi des dossiers CMC pour les drogues/produits et la résolution/formulation des réponses soulevées par les autorités gouvernementales
- Effectue les tâches réglementaires, incluant la rédaction des sections CMC des dossiers associées aux transferts de produits et celles requises suite à des demandes de changements
- S’assure de la diffusion des documents CMC approuvés au site de Laval et/ou aux fournisseurs et/ou clients
- Assure un support à l’évaluation et la résolution des problèmes techniques en émettant des opinions réglementaires, au besoin
- Apporte l’évaluation réglementaire pour les demandes de changement pour produits sous sa responsabilité

**Conformité et développement qualité**
- Est garant de la mise en œuvre des procédures qualité internes applicables
- Élabore et révise les procédures qualité reliées à son champ d’activité
- Assure la vérification/approbation des spécifications lorsque nécessaire (nouveaux produits)
- S’assure du suivi lors de l’intégration de nouveaux produits
- Effectue les audits qualité internes
- Initie et assure le suivi des demandes de changements sous sa responsabilité, au besoin
- Assure un support conformité BPF pour ce qui a trait aux dossiers produits
- Assure et coordonne le renouvellement des licences d’établissement, des annexes de sites étrangers et le renouvellement des licences de produits de santé naturels
- Est garant du respect de la réglementation Qualité et du contrôle des changements:

- Fournisseurs de matières premières et composantes d’emballages
- Tiers

Approuve les spécifications d’achat pour les matières premières et composantes d’emballage utilisées à l’usine

Est Remplaçant : Spécialiste Assurance Qualité et Conformité (CMC et Audits) - fonctions CMC,

Chef Projets CMC, Chef Principal, Assurance Qualité et Conformité - fonctions

GMP

**Relations extérieures (réglementaire et clients)**
- Assure la définition et la mise en œuvre du programme d’audit des fournisseurs, des tiers et des audits internes
- Assure le suivi des rapports d’audit et de la mise en œuvre des recommandations / actions correctives
- Participe au programme de certification des fournisseurs en collaboration avec le laboratoire du contrôle de la qualité
- Est l’interlocuteur AQ auprès des fournisseurs de matières premières et composantes d’emballage, au besoin
- Participe à la tenue des audits externes (clients ou réglementaires) sur le site, au besoin

**HSE**
- Applique au quotidien les politiques HSE
- Propose des améliorations HSE

**Ressources (moyens)** (budget, investissements)

dimension du budget à gérer

liberté d’engager des investissements financiers-niveaux d’autorisation
- Contribue aux objectifs annuels de performance de son département
- Gère les priorités en fonction des besoins et délais
- Propose des solutions pour améliorer la performance dans son périmètre de responsabilité

**Principales relations professionnelles** (internes / externes)

[qui sont les partenaires à l’interne?]

[qui sont les partenaires à l’externe? / Type d’activités avec ces partenaires]
- Rapporter au Chef Principal, Assurance Qualité et Conformité
- Assure une liaison permanente avec les services opérationnels pour obtenir/diffuser les informations
- Participe à des groupes de travail pluridisciplinaire (transfert de produits, contrôle

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