Quality Assurance Associate III

Job Description

POSITION SUMMARY

Responsible for Quality Compliance and Product Quality related activities for Sanofi Canada’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.

KEY RESPONSIBILITIES AND DUTIES FOR THIS JOB

• Serve in a backup capacity to other Quality Specialists for their respective responsibilities.
• Plan 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
• Supports 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

EDUCATION

B.Sc. in Chemistry, Biology or related sciences from a Canadian University or formal certificate of equivalency*

EXPERIENCE

Minimum of 3 to 5 years of related experience within the pharmaceutical industry.

Key Notes :

• B.Sc. in Chemistry, Biology or related sciences.
• Minimum of 3 to 5 years of related experience within the pharmaceutical industry.
• Quality Compliance and Product Quality related activities for Sanofi Canada’s importation and distribution portfolio. Perform compliance requirements such as executed batch record review, stability review, APQR etc.
• Release products and APIs on the Canadian market after completing the necessary document review

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