Spécialiste assurance qualité – Validation & Support Développement de produits

Groupe PARIMA; Quebec; Hybrid; CAD 70,000 - 90,000; Full time

Job summary

Un leader en sous-traitance pharmaceutique recherche un Spécialiste Assurance Qualité pour soutenir ses activités de validation et de gestion des fournisseurs. Avec au moins 5 ans d'expérience, vous serez responsable de la conformité des documents et de l'introduction de nouveaux produits essentiels dans un environnement dynamique. Ce poste offre des options de travail à distance, des programmes de reconnaissance, et de soutien, garantissant un équilibre entre vie professionnelle et personnelle.

Benefits

Assurance médicale et dentaire

Plan de retraite collectif

Options de travail à distance

Programmes de reconnaissance

Jours de congé personnel

Programmes de soutien et télémédecine

Boissons gratuites

Transports en commun accessibles

Programmes de référence

Qualifications

• Minimum 5 ans d'expérience en assurance qualité dans l'industrie pharmaceutique.
• Expérience éprouvée en validation des processus et qualification d'équipements.
• Connaissance des lignes directrices GMP canadiennes et américaines.

Responsibilities

• Réviser et approuver les protocoles de validation et les rapports.
• Gérer le programme de qualification des fournisseurs.
• Participer aux lancements de nouveaux produits.

Skills

Validation de processus

Validation de nettoyage

Qualification d'équipements

Connaissance des directives GMP

Rigueur

Autonomie

Compétences en communication

Education

Baccalauréat en chimie, biologie ou sciences pharmaceutiques

Job description

Spécialiste assurance qualité – Validation & Support Développement de produits

Join to apply for the Spécialiste assurance qualité – Validation & Support Développement de produits role at Groupe PARIMA

Groupe PARIMA, active since 1994, specializes in development and manufacturing subcontracting, with expertise in non-sterile pharmaceutical products in liquid, semi-solid, or suspension forms. https://www.groupeparima.com/fr/

Position Overview

This role supports quality assurance activities including:

• Review and approval of validation documents (processes, cleaning, equipment)
• Qualification and management of suppliers
• Introduction of new products within the Product Development Services (PDS) program
• Review of controlled documents in a cGMP-compliant environment

Key Responsibilities

Validation and Qualification

• Review and approve validation protocols and reports for processes and cleaning
• Review qualification documents for equipment and utilities
• Participate in validation meetings as needed
• Draft and review deviation reports related to process validation, cleaning, and equipment qualification
• Review and approve change controls related to validations and qualifications
• Implement and monitor CAPAs

Supplier Qualification Program

• Review questionnaires, evaluations, and audits of suppliers
• Collaborate with technical and purchasing departments to ensure qualification compliance
• Maintain approved supplier database
• Draft deviation reports related to qualified suppliers
• Review and approve change controls for supplier qualification
• Implement and monitor CAPAs

Support for New Product Development and Introduction

• Participate in cross-functional meetings for new product launches
• Review and approve change controls, master documents, and master files
• Ensure documentation compliance for client projects

Documentation and GMP Compliance

• Review and approve controlled documents (SOPs, work instructions, specifications)
• Utilize the ACE system for document lifecycle activities

Additional Responsibilities

• Participate in continuous quality process improvements
• Assist in preparing or conducting client or regulatory audits

Required Skills and Experience

• Bachelor's degree in chemistry, biochemistry, microbiology, pharmaceutical sciences, or related field
• At least 5 years of experience in Quality Assurance within the pharmaceutical, biotechnological, or CDMO industry
• Proven experience in process validation, cleaning validation, and equipment qualification
• Experience managing suppliers and GMP documentation
• Strong knowledge of Canadian (Health Canada), U.S. (FDA) GMP guidelines, and ICH Q7, Q8, Q9, Q10 guidelines
• Ability to work in a dynamic, client-oriented environment
• Rigour, autonomy, organizational skills, and critical thinking
• Excellent writing and communication skills

What We Offer

• Medical, dental, and travel insurance
• Group retirement plan
• Remote work options
• Recognition programs and social activities
• Personal days off
• Employee support programs and telemedicine
• Free beverages (hot chocolate, coffee, mokaccino)
• Accessible public transportation or free parking
• Referral and subsidized meal programs

This job posting is active and accepting applications.