Job Description

Specialiste, Systemes d'Assurance Qualite

Jubilant HollisterStier, une filiale de Jubilant Pharma Holdings Inc., est actuellement a la recherche d'un

Specialiste, Systemes d'Assurance Qualite

pour rejoindre notre equipe !

Ce que nous offrons :

Une culture qui valorise la croissance et les opportunites de developpement professionnel, un salaire de base tres competitif, des programmes complets d'assurance medicale, dentaire et d'invalidite, un regime de retraite collectif ainsi que des programmes de sante et de bien-etre. Jubilant HollisterStier est une entreprise en pleine croissance, avec des bureaux a Kirkland (Quebec) et a Spokane (Washington). En tant qu'organisation de fabrication sous contrat entierement integree, Jubilant HollisterStier a la capacite de produire des formulations injectables steriles ainsi que des formes posologiques solides et semi-solides. Nos quatre installations en Amerique du Nord et en Inde offrent des services de fabrication specialises pour les secteurs pharmaceutique et biopharmaceutique. Jubilant HollisterStier fait fierement partie de la famille Jubilant Pharma. Pour plus d'informations, visitez : www.jublhs.com.


Nous continuerons, avec le plus grand soin pour l'environnement et la societe, a creer de la valeur pour nos clients et partenaires en offrant des produits innovants et des solutions rentables grace a la croissance, la rentabilite et a un investissement judicieux des ressources. Si vous etes pret pour un defi enrichissant, nous vous invitons a franchir le premier pas et a postuler des aujourd'hui !


Jubilant Pharma Holdings Inc. et toutes ses filiales sont fieres de la diversite de leur personnel. Notre objectif est d'avoir une main-d'?uvre aussi diversifiee que les patients et clients que nous servons. Nous favorisons un environnement inclusif ou nos employes peuvent s'epanouir et ou nos differences sont accueillies. En valorisant nos differences, nous creons des produits qui beneficient a nos patients, nos clients et a la sante humaine en general.

Objectif du poste

Coordonner et soutenir les systemes axes sur la qualite afin d'optimiser les processus de Jubilant et d'assurer un contenu technique approprie ainsi que la conformite aux reglements BPF, aux normes de Jubilant et aux exigences des clients.

Responsabilites cles

Specialiste, Systemes d'Assurance Qualite (fonction APQR)

Revue annuelle des produits (RAP) : recueillir et compiler les donnees, et les transmettre au client selon les echeances etablies. Assurer l'integrite et la tracabilite de toutes les donnees generees et rapportees. Avertir immediatement le gestionnaire de toute non-conformite, tendance anormale, information incomplete ou autre irregularite. Mener des initiatives qualite au niveau documentaire et procedural afin d'optimiser les operations et programmes de Jubilant. Assurer l'amelioration continue des procedures en place et la conformite aux nouveaux systemes/processus et exigences reglementaires. Effectuer d'autres taches assignees par la direction.

Specialiste, Systemes d'Assurance Qualite (fonction Gestion des modifications)

Gestion des changements : coordonner les changements pour determiner leur impact sur les produits et/ou les processus. Mener des initiatives qualite au niveau documentaire et procedural afin d'optimiser les operations et programmes de Jubilant. Effectuer d'autres taches assignees par le gestionnaire du departement des systemes qualite.

Specialiste, Systemes d'Assurance Qualite (fonction SOPs et documentation)

Administrer, coordonner ou executer les activites et la documentation suivantes : + Evaluer et approuver les changements relatifs aux procedures normalisees (SOP).
+ Mettre en forme et emettre les SOP.
+ Telecharger les documents dans SAP a des fins d'approbation.
+ Distribuer les copies controlees des SOP et s'assurer de la destruction des versions obsoletes.
+ Maintenir la base de donnees des copies papier controlees.
+ Notification et suivi des revisions des SOP.
+ Controle maitre des documents : emission ou annulation selon les taches et notifications.
+ Emission des dossiers de lots pour la fabrication, le conditionnement et l'inspection.
+ Impression des dossiers de lots, etiquettes de stabilite, plans d'echantillonnage et etiquettes correspondantes.
+ Verification et confirmation des fiches PI dans SAP.
+ Impression des etiquettes d'identification pour la production, si applicable.

Specialiste, Systemes d'Assurance Qualite (fonction Specifications)

Preparer, reviser et maintenir les specifications des produits finis, matieres premieres et composants d'emballage dans SAP en assurant l'exactitude technique, la conformite aux exigences des clients, aux BPF et aux normes des pharmacopees, tout en respectant les delais. Emettre et maintenir les methodes analytiques et/ou les ordres de travail analytiques. Fournir un soutien technique relatif aux exigences reglementaires concernant les contaminants (TSE/BSE, etc.). Traduire les exigences reglementaires et celles des clients en documentation technique, et assurer la communication interne a ce sujet aux departements concernes. Effectuer toute autre tache assignee par la direction.

Interfaces cles

Interfaces externes :

Clients

Interfaces internes :

Operations, Qualite, Production, Commercial, Validation, Services techniques, Chaine d'approvisionnement

Qualifications :

Formation :

Baccalaureat en chimie, microbiologie ou discipline connexe.

Experience requise :

Minimum de cinq (5) ans d'experience en assurance / controle qualite ou en conformite reglementaire dans l'industrie pharmaceutique ou des soins de sante.

Competences requises :

Connaissance des pharmacopees (USP, EP, BP) et des reglements BPF. Connaissance generale des systemes qualite, des operations et des processus de controle qualite. Maitrise des outils informatiques et de la saisie de donnees (Microsoft Office, TrackWise, MasterControl et environnement SAP). Bilinguisme (francais et anglais). La maitrise de l'anglais est essentielle.

Specialist, Quality Assurance Systems

Jubilant HollisterStier, a subsidiary of Jubilant Pharma Holdings Inc., is currently recruiting a

Specialist, Quality Assurance Systems

to join our team!

What do we offer?

A culture that values growth and professional development opportunities, a highly competitive base salary, comprehensive medical, dental, and disability insurance programs, a group retirement plan, as well as health and wellness programs. Jubilant HollisterStier is a rapidly growing company with offices in Kirkland, Quebec, and Spokane, Washington. As a fully integrated contract manufacturing organization, Jubilant HollisterStier has the capability to manufacture sterile injectable formulations, as well as solid and semi-solid dosage forms. Our four facilities in North America and India provide specialized manufacturing services for the pharmaceutical and biopharmaceutical sectors. Jubilant HollisterStier proudly belongs to the Jubilant Pharma family. For more information, visit www.jublhs.com.


We will continue, with the greatest care for the environment and society, to create value for our customers and stakeholders by offering innovative products and cost-effective solutions through growth, profitability, and prudent resource investment. If you're ready for a rewarding challenge, we invite you to take the first step and apply today!


Jubilant Pharma Holdings Inc. and all our subsidiaries are proud of the diversity of our workforce. Our goal is to have a workforce as diverse as the patients and clients we serve. We have an inclusive environment where our employees can thrive, and where our differences are welcomed. By embracing our differences, we create products that benefit our patients, clients, and human health in general.

Position Objective

Coordinates and supports quality-based systems in order to optimize Jubilant' processes and


ensures appropriate technical content and compliance to GMP regulations, Jubilant' standards and customers' requirements.

Key Accountabilities

Responsibilities:

Specialist, Quality Assurance Systems (APQR sub-function):

Annual product review: (APR) Gathers and compiles data, and provides to customer as perestablished timeline. Ensures integrity and traceability of all data generated and reported. Notifies immediately Manager of any out-of-specification, out-of-trend, incomplete information and other irregularities. Leads quality based initiatives at both documentation and process level in order to optimizeJubilant's operations and programs. Ensures ongoing improvement of established proceduresand adherence to new systems/processes and compliance with regulatory requirements. Performs additional duties as assigned by Management.

Specialist, Quality Assurance Systems (CC sub-function):

Change control management: Coordinates change controls to determine impacts on productsand/or processes. Leads quality based initiatives at both documentation and process level in order to optimizeJubilant's operations and programs. Ensures ongoing improvement of established proceduresand adherence to new systems/processes and compliance with regulatory requirements. Performs additional duties as assigned by the Manager, Quality Systems Department. Performs any other tasks assigned by Management.

Specialist, Quality Assurance Systems (SOPs and documentation sub-function):

Administers, coordinates, or executes the following activities and documentation. Evaluate and approve change controls related to SOP's. Format and issue SOP's. Load documents in SAP for approval purposes (SOP's) Distribute controlled copies of SOP's and ensure that all obsolete copies are destroyed. Maintains database of controlled paper copies of SOP's Notification and follow-up for SOP review Master documentation control of SOPs such as issuing or cancelling documents according to

tasks in notifications.

Issue production batch records for manufacturing, packaging and inspection. Print production batch records for manufacturing, packaging and inspection. Print Stability labels according to SOP if required Print Sampling Plan and corresponding labels according to instructions. Verification and Confirmation of the PI Sheet in SAP Print identification labels for production if applicable

Specialist Quality Assurance Systems (Specifications sub-fonction):

Prepares, reviews and maintains specifications for finished products, raw materials andpackaging components in SAP ensuring technical accuracy and compliance to customers'requirements, GMP, and compendia standards, and adherence to established timelines. Issues and maintains analytical methods, and/or analytical work orders. Provides technical support and guidance relative to the TSE/BSE and other regulatorycontaminants requirements Translates applicable regulatory requirements as well as customers' requirements into technicaldocumentation and ensures internal communication of these to appropriate departments Performs additional duties as assigned by Management.

Key Interfaces

External Interfaces

Clients

Internal Interfaces

Operations, Quality, Production, Commercial, Validation, Technical Services, Supply Chain

Education Qualification:

BSc in chemistry, microbiology or closely related discipline.

Experience Required:

Minimum five (5) year experience working in QualityAssurance/control or regulatory compliance within pharmaceutical or healthcare industry.

Skills Required:

Knowledge with compendia (USP, EP, and BP) and cGMP regulations. General knowledge of Quality systems, Operations and Quality control processes. Proficiency in computer and data entry (Microsoft Office, TrackWise, MasterControl andSAP environment). Bilingual (French & English). Proficiency in English is essential.

Job Overview

DATE POSTED :

22/08/25

LOCATION :

Montreal, Quebec

COMPANY :

Jubilant HollisterStier General Partnership

FUNCTION :

Quality