Quality Assurance Associate

Quality Assurance Associate III (6-month contract)

Toronto, ON

Introduction

We are hiring a Quality Assurance Associate III for our client based in Toronto, Ontario. The Quality Assurance Associate will be responsible for Quality Compliance and Product Quality related activities for the company’s importation and distribution portfolio.

Contribute to establishing and maintaining high quality and compliance status of all products to meet all Canadian cGMP regulations, as well as corporate requirements.

This is a 6-month contract position.

Responsibilities

• Serve in a backup capacity to other Quality Specialists for their respective responsibilities and coordinate daily, weekly and monthly release activities.
• Collect, review and approve all required documentation necessary for product release, including batch documentation review.
• Perform periodic (eg. Annual) compliance requirements such as executed batch record review, stability review, APQR etc.
• Release products and APIs on Canadian market after completing necessary document review.
• Send products for testing, approve results and support laboratories, if required
• Complaint Officers in the following capacity as required.
• Monitors and tracks sample receipt from complaints.
• Performs QC Checks
• Understands Health Canada complaint regulations for drug products and medical devices
• Supports trending reports
• Provides complaint support to other company departments including Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management
• Participates on ad-hoc teams regarding product-specific complaint issues
• Coordinates feedback to customers regarding complaint investigations via QA Coordination Call Center
• Participate and support Regulatory Inspections (Health Canada), as well as internal and corporate audits, as required
• Participate and support Self-inspection Program
• Support Quality Performance Indicators for QA activities
• Other QA duties, as assigned

Requirements

• B.Sc. in Chemistry, Biology or related sciences from a Canadian University or formal certificate of equivalency*
• Minimum of 3 to 5 years of related experience within the pharmaceutical industry.
• Experience performing compliance requirements such as executed batch record review, stability review, APQR etc.
• Experience with released products and APIs on the Canadian market after completing the necessary document review

What We Offer

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We’ll get you going while you get on with the job.

About Us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.