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Closed listing

Lernapharm (LORIS) Inc.

Assistant(e), Assurance qualité et Affaires réglementaires

Montreal, QC, Canada

Full-time

This opening has closed.

The original listing is kept below for reference.

Find open jobs More jobs with this employer

About employer

Job details

Job type: Full-time
Closing date: Nov 2, 2026
Posting language: English · French
Posted: Oct 3, 2026

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Original job description

Archived listing. The details below describe a past opening.

English section of this bilingual listing.

We are seeking an Assistant, Quality Assurance & Regulatory Affairs to join our Quality team and

support the maintenance and continuous improvement of the Company’s Quality Management

System, while ensuring compliance with applicable GMP and regulatory requirements.

Key Responsibilities

Assist the Director, Quality Assurance & Regulatory Affairs (QA/RA) with the disposition

(release, reject, on-hold, quarantine) of raw materials, packaging materials and finished

products.

Assist in the preparation of Annual Product Reviews (APR) and Management Review

reports, and prepare periodic trend reports.

Assist in the establishment, implementation, evaluation and maintenance of processes

required for the Quality Management System, ensuring that products manufactured in-

house or under contract, as well as imported products, meet applicable GMP and

regulatory requirements.

Assist in maintaining regulatory, QA, QC and other GMP-related documentation and

files.

Manage and maintain retain samples, including inspection and inventory control.
Coordinate change controls, risk assessments, anomalies, deviations and OOS

investigations.

Coordinate planning and execution of CAPA activities.
Draft, review and revise Standard Operating Procedures (SOPs) and related forms.
Investigate and respond to customer complaints.
Monitor stability studies and applicable microbiological testing activities in accordance

with the established stability program.

Monitor the Pest Control and Sanitation Programs.
Participate in planning and conducting internal quality audits.
Provide GMP and SOP training to personnel and support training documentation.
Verify accompanying documentation for raw and packaging materials according to the

established specifications.

Review and verify bulk solution and finished product batch records (Work Orders).
Assist with the review and follow-up of environmental monitoring, microbiological

testing and related quality records, as applicable.

Perform other quality-related tasks and projects as assigned or delegated by the

Director, QA/RA.

Education

Bachelor’s degree in microbiology, Biology, Biochemistry, Pharmaceutical Sciences,

Quality Assurance, or a related scientific discipline.

Experience

Minimum 2–3 years of experience in a GMP-regulated manufacturing environment.
Experience in microbiology, environmental monitoring, quality control testing, product

release, investigations and quality systems is considered a strong asset.

Strong organizational, analytical and communication skills.
Ability to work independently while collaborating effectively with cross-functional

teams.

Strong attention to detail and ability to manage multiple priorities in a regulated environment.

Read the full bilingual original

Nous sommes à la recherche d’un(e) Assistant(e), Assurance qualité et Affaires réglementaires

pour se joindre à notre équipe Qualité et contribuer au maintien et à l’amélioration continue du

système de gestion de la qualité de l’entreprise, tout en veillant au respect des exigences

applicables en matière de BPF et de réglementation.

Principales responsabilités

Assister le/la Directeur(trice), Assurance qualité et Affaires réglementaires (AQ/AR), dans la

prise de décision concernant la disposition des matières premières, des matériaux d’emballage

et des produits finis (libération, rejet, mise en attente ou mise en quarantaine).

Participer à la préparation des revues annuelles des produits (RAP) et des rapports de

revue de direction, ainsi qu’à la préparation de rapports périodiques de tendances.

Participer à l’établissement, à la mise en œuvre, à l’évaluation et au maintien des

processus requis pour le système de gestion de la qualité, en veillant à ce que les

produits fabriqués à l’interne ou sous contrat, ainsi que les produits importés,

respectent les exigences applicables en matière de BPF et de réglementation.

Assurer le maintien des documents et dossiers réglementaires, d’AQ, de CQ et autres

documents liés aux BPF.

Gérer et maintenir les échantillons de rétention, notamment leur inspection et le

contrôle des stocks.

Coordonner les contrôles des changements, les évaluations des risques, les anomalies,

les déviations et les enquêtes relatives aux résultats hors spécifications (OOS).

Coordonner la planification et la réalisation des activités liées aux CAPA (actions

correctives et préventives).

Rédiger, réviser et mettre à jour les procédures opératoires normalisées (PON) et les

formulaires connexes.

Enquêter sur les plaintes des clients et y répondre.

Assurer le suivi des études de stabilité et des activités de contrôle microbiologique

applicables, conformément au programme de stabilité établi.

Assurer le suivi des programmes de lutte antiparasitaire et d’assainissement.

Participer à la planification et à la réalisation des audits internes de qualité.

Offrir des formations sur les BPF et les PON au personnel et assurer le suivi de la

documentation relative aux formations.

Vérifier la documentation accompagnant les matières premières et les matériaux

d’emballage conformément aux spécifications établies.

Réviser et vérifier les dossiers de fabrication des solutions en vrac et des produits finis

(ordres de fabrication).

Participer à la révision et au suivi de la surveillance environnementale, des analyses

microbiologiques et des dossiers qualité connexes, le cas échéant.

Effectuer toute autre tâche ou tout autre projet lié à la qualité qui lui est confié ou

délégué par le/la Directeur(trice), AQ/AR.

Formation

Baccalauréat en microbiologie, biologie, biochimie, sciences pharmaceutiques,

assurance qualité ou dans une discipline scientifique connexe.

Expérience et compétences

Minimum de 2 à 3 ans d’expérience dans un environnement de fabrication réglementé

par les BPF.

Une expérience en microbiologie, en surveillance environnementale, en contrôle de la

qualité, en libération de produits, en investigation et dans les systèmes de gestion de la

qualité constitue un atout important.

Excellentes aptitudes organisationnelles, analytiques et communicationnelles.

Capacité à travailler de façon autonome tout en collaborant efficacement avec des

équipes interfonctionnelles.

Grand souci du détail et capacité à gérer plusieurs priorités dans un environnement

réglementé.

______________________________________________

Assistant, Quality Assurance & Regulatory Affairs

We are seeking an Assistant, Quality Assurance & Regulatory Affairs to join our Quality team and

support the maintenance and continuous improvement of the Company’s Quality Management

System, while ensuring compliance with applicable GMP and regulatory requirements.

Key Responsibilities

Assist the Director, Quality Assurance & Regulatory Affairs (QA/RA) with the disposition

(release, reject, on-hold, quarantine) of raw materials, packaging materials and finished

products.

Assist in the preparation of Annual Product Reviews (APR) and Management Review

reports, and prepare periodic trend reports.

Assist in the establishment, implementation, evaluation and maintenance of processes

required for the Quality Management System, ensuring that products manufactured in-

house or under contract, as well as imported products, meet applicable GMP and

regulatory requirements.

Assist in maintaining regulatory, QA, QC and other GMP-related documentation and

files.

Manage and maintain retain samples, including inspection and inventory control.

Coordinate change controls, risk assessments, anomalies, deviations and OOS

investigations.

Coordinate planning and execution of CAPA activities.

Draft, review and revise Standard Operating Procedures (SOPs) and related forms.

Investigate and respond to customer complaints.

Monitor stability studies and applicable microbiological testing activities in accordance

with the established stability program.

Monitor the Pest Control and Sanitation Programs.

Participate in planning and conducting internal quality audits.

Provide GMP and SOP training to personnel and support training documentation.

Verify accompanying documentation for raw and packaging materials according to the

established specifications.

Review and verify bulk solution and finished product batch records (Work Orders).

Assist with the review and follow-up of environmental monitoring, microbiological

testing and related quality records, as applicable.

Perform other quality-related tasks and projects as assigned or delegated by the

Director, QA/RA.

Education

Bachelor’s degree in microbiology, Biology, Biochemistry, Pharmaceutical Sciences,

Quality Assurance, or a related scientific discipline.

Experience

Minimum 2–3 years of experience in a GMP-regulated manufacturing environment.

Experience in microbiology, environmental monitoring, quality control testing, product

release, investigations and quality systems is considered a strong asset.

Strong organizational, analytical and communication skills.

Ability to work independently while collaborating effectively with cross-functional

teams.

Strong attention to detail and ability to manage multiple priorities in a regulated environment.

About employer

More about this job

Responsibilities

Support the Quality Management System and ensure products and processes comply with applicable GMP and regulatory requirements. Coordinate product disposition, documentation, investigations, CAPA, stability and microbiological activities, audits, training, and quality records.

Requirements

A bachelor’s degree in microbiology, biology, biochemistry, pharmaceutical sciences, quality assurance, or a related scientific discipline is required. Candidates need 2–3 years of experience in GMP-regulated manufacturing; experience in microbiology, environmental monitoring, quality control, product release, investigations, or quality systems is an asset.

Skills

GMP Compliance
Quality Management Systems
Quality Assurance
Regulatory Affairs
Product Disposition
Annual Product Reviews
Trend Reporting
Document Control
Retain Sample Management
Change Control
Risk Assessment
Deviation and OOS Investigations
CAPA Coordination
SOP Writing and Revision
Stability Studies
Internal Quality Audits

Visa sponsorship

Not detected in the job text

Keywords

Good Manufacturing Practices
GMP
Quality Management System
Quality Assurance
Regulatory Affairs
Quality Control
Annual Product Review
Management Review
Trend Reports
Product Release
Raw Materials
Packaging Materials
Finished Products
Retain Samples
Change Control
Risk Assessment
Deviations
Out-of-Specification Investigations
CAPA
Standard Operating Procedures
Customer Complaints
Stability Studies
Microbiological Testing
Pest Control
Sanitation
Internal Audits
Environmental Monitoring
Batch Records
Training Documentation

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