Quality Systems Specialist
New
CanadaFull-TimeMiddle
Salary not disclosed
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Job Details
- Languages
- English, French
- Experience
- Minimum of 3 years
- Required Skills
- GCPDocumentationQuality Assurance
Requirements
- Bachelor’s degree in a relevant discipline or equivalent experience.
- Minimum of 3 years of experience in quality assurance within pharmaceutical, biotech, or clinical research environments.
- Strong understanding of GxP regulations, including ICH guidelines and requirements from Health Canada, FDA, and EU authorities.
- Experience in audit execution, CAPA management, deviation handling, and quality system documentation.
- Knowledge of Good Clinical Practices (GCP) and familiarity with GMP principles.
- Strong communication skills in both English and French (written and spoken).
- Excellent organizational skills with the ability to manage priorities in a fast-paced environment.
- Proficiency in Microsoft Office tools and familiarity with digital quality systems.
- Ability to collaborate effectively across multidisciplinary teams.
- Experience in vendor oversight, clinical quality, or therapeutic areas such as dermatology or rheumatology is an asset.
Responsibilities
- Execute and support internal audit activities, including audit planning, execution, reporting, and follow-up on observations and CAPA closure.
- Review deviations, non-conformities, and quality system findings while tracking trends and ensuring effective CAPA management.
- Support inspection readiness and participate in client audits, regulatory inspections, and mock inspections, including completion of RFIs.
- Contribute to the maintenance and continuous improvement of the Quality Management System (QMS), including documentation updates and quality records.
- Collaborate on vendor management activities, including vendor qualification, risk assessments, and oversight of CAPA related to supplier findings.
- Support quality training initiatives by contributing to training materials and delivering sessions on GxP and quality system topics.
- Perform IP release activities in compliance with GMP requirements, as applicable.
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