Senior Quality Assurance Associate
Canada, Quebec, Laval
/ CA$ 70000 - 109000 per year
Experience: 6-9 Years
Life Sciences
Introduction
Our client is seeking a Senior Quality Assurance Associate to support and maintain quality systems, regulatory compliance, and GMP standards within a pharmaceutical environment. This role will be responsible for overseeing quality processes, managing quality events, supporting audits and inspections, and ensuring products meet applicable regulatory and company requirements.
What are you going to do
- 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.
Essential skills and knowledge
- 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.
What we offer
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