Senior Quality Assurance Associate
Canada, Quebec, Laval
Experience: 6-9 Years
Life Sciences
职位描述
- Ensure compliance with Health Canada regulations, GMP requirements, and internal quality standards.
- Maintain and support continuous improvement of the Quality Management System (QMS).
- Manage deviations, non-conformances, quality complaints, change controls, and CAPAs.
- Review batch documentation and support product disposition activities.
- Coordinate annual product quality reviews and identify quality trends and improvement opportunities.
- Manage product recalls and withdrawals when required.
- Oversee supplier and subcontractor quality performance and maintain quality agreements.
- Participate in internal, external, and regulatory audits and inspections.
- Support inspection readiness and follow-up on audit observations and corrective actions.
- Provide quality guidance and training to internal teams.
- Collaborate with cross-functional stakeholders to ensure ongoing compliance and operational excellence.
- Bachelor's degree in Life Sciences, Health Sciences, or a related scientific discipline.
- Minimum 10 years of Quality Assurance experience within the pharmaceutical industry.
- Experience working in a GMP-regulated manufacturing or production environment.
- Strong knowledge of Health Canada regulations, Food and Drug Regulations, and Good Manufacturing Practices (GMP).
- Experience managing quality systems, CAPAs, deviations, change controls, and audits.
- Strong analytical, organizational, and problem-solving skills.
- Ability to manage multiple priorities in a fast-paced environment.
- Excellent communication and stakeholder management skills.
- Bilingualism in English and French is required.
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截止日期: 2026年10月31日