Spécialiste Assurance Qualité | Quality Assurance, Specialist

Organon

Not specified; annualized salary range (global) va...
Gmp regulatory compliance knowledge
Batch record review and disposition
Quality complaint investigation
The Quality Assurance Specialist ensures all products are manufactured, packaged, tested, released, stored, and distributed in strict accordance with Organon requirements and Canadian regulations

Job Summary

  • The Quality Assurance Specialist ensures all products are manufactured, packaged, tested, released, stored, and distributed in strict accordance with Organon requirements and Canadian regulations.
  • Key responsibilities include conducting full batch record reviews, managing quality complaints, coordinating deviations, and overseeing supplier audits to maintain compliance.
  • The role requires promoting continuous improvement through MPS, Six Sigma, and Kaizen methodologies while ensuring data integrity via ALCOA principles.

Matching Summary

The Quality Assurance Specialist ensures all products are manufactured, packaged, tested, released, stored, and distributed in strict accordance with Organon requirements and Canadian regulations.

Salary

Not specified; Annualized Salary Range (Global) varies by local market; Not specified

Skills & Requirements

Must-have

  • GMP regulatory compliance knowledge
  • Batch record review and disposition
  • Quality complaint investigation
  • Deviation and non-conformity management
  • Change control assessment
  • Supplier audit support
  • Data integrity ALCOA principles

Nice-to-have

  • Six Sigma continuous improvement
  • Kaizen and Kata process participation
  • Temperature excursion impact assessment
  • Stability report review experience
  • Biologics distribution certification

Key Requirements

  • Knowledge of Canadian GMP regulations
  • Experience with biologics products
  • Proficiency in change control systems
  • Ability to conduct supplier audits
  • Understanding of stability testing protocols

Work Rights

Not specified

Tailored Resume

Cover Letter