Spécialiste assurance qualité – Validation & Support Développement de produits

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

Job summary

A pharmaceutical manufacturing company in Capitale-Nationale, Quebec, is seeking an experienced Quality Assurance professional. The role involves reviewing and approving validation documents and ensuring compliance with GMP regulations. Ideal candidates will have a bachelor's degree in a relevant field and at least 5 years of experience in quality assurance. The position offers benefits such as remote work options, medical insurance, and employee support programs.

Benefits

Medical, dental, and travel insurance

Remote work options

Recognition programs

Personal days off

Free beverages

Referral and subsidized meal programs

Qualifications

• At least 5 years of experience in Quality Assurance within the pharmaceutical industry.
• Strong knowledge of Canadian and U.S. GMP guidelines.
• Ability to work in a dynamic, client-oriented environment.

Responsibilities

• Review and approve validation protocols for processes and cleaning.
• Implement and monitor CAPAs.
• Participate in cross-functional meetings for new product launches.

Skills

Process validation

Communication skills

GMP documentation

Supplier management

Critical thinking

Education

Bachelor's degree in chemistry or related field

Job description

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
• Review questionnaires, evaluations, and audits of suppliers
• Collaborate with technical and purchasing departments to ensure qualification compliance
• 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

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
• 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.

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Assurance Assurance • Quebec, Capitale-Nationale, Canada