Validation Specialist, Quality Assurance

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About the role

  • Quality Assurance Validation Specialist reviewing protocols and documentation to ensure regulatory compliance. Collaborating with cross-functional teams in a biopharmaceutical manufacturing environment.

Responsibilities

  • Review and approve IQ/OQ protocols and reports to ensure they meet internal standards and regulatory requirements
  • Ensure validation documentation is complete, accurate, and traceable
  • Review work orders related to maintenance, calibration, or qualification of equipment
  • Ensure all work is properly documented and compliant with Good Documentation Practices (GDP)
  • Identify gaps or discrepancies in validation documentation and ensure appropriate corrective actions are taken
  • Work closely with validation engineers and cross-functional teams in quality control, manufacturing, and maintenance
  • Participate in audits and inspections, providing validation documentation as required

Requirements

  • Bachelor’s degree in science minimum (preferably in microbiology, chemistry, or biology)
  • At least 2–3 years of quality assurance experience within the biopharmaceutical or pharmaceutical manufacturing industry
  • Specialist-level expertise with advanced knowledge of quality systems
  • Good understanding of validation principles (IQ/OQ/PQ)
  • Proficient computer skills with MS Office and Adobe Acrobat
  • Strong organizational skills, attention to detail, and ability to meet deadlines
  • Bilingual in French and English
  • Able to work independently and as part of a team

Benefits

  • 5 days off
  • Health and wellness program
  • Remote work option
  • Professional development

Job title

Job type

Full Time

Experience level

JuniorMid level

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

OnsiteMontrealCanada

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