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.

Functieomschrijving

  • 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.

Vereisten

  • 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.

Arbeidsvoorwaarden

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Sluitingsdatum: 31 oktober 2026

Solliciteren

Contactgegevens vacature

Vacaturenummer: PR-297370

ON

Talent Acquisition Consultant

Olivia Neyra

+1 403 539 5009

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