Quality Assurance Specialist
2 months ago
Job Summary: We are seeking a highly skilled Quality Assurance Specialist to support our global Quality standards in the Canadian market. This role will focus on ensuring product quality, regulatory compliance, and efficiency in our manufacturing and distribution processes.
Main Responsibilities:
- Perform final release of products intended for distribution in Canada under the supervision of the Canadian Head of Quality.
- Conduct Quality Assurance activities relating to Third Party Manufacturing/Warehousing, including AQL Inspection, maintaining Quality Assurance files and trackers, audits, deviations, and investigations.
- Assist with Change Controls, SOP review and revisions, and archival of GMP records.
- Maintain Finished Product Specifications.
Key Performance Indicators:
- Quality Standards are met for material released in the Canadian Market.
- Transactions are processed in a timely manner.
- Supplier qualification activities satisfy all regulatory requirements and audit reviews.
Additional Responsibilities:
- Propose improvement actions and report regularly on implementation progress.
- Track third-party performance and report regularly to local and corporate departments.
- Focus on standardizing all operations to improve operating compliance and performance standards.
Requirements:
- Canadian University degree or a degree recognized as equivalent by Canadian accreditation body in a science-related field.
- Minimum 2-3 years of experience in pharmaceutical manufacturing/distribution environment.
- Excellent communication, critical thinking, collaboration, analytical, and attention to detail skills.
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