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QC Validation SpecialistCareerWise Recruitment • Kingston, ON, Canada
QC Validation Specialist

QC Validation Specialist

CareerWise Recruitment • Kingston, ON, Canada
10 days ago
Job type
  • Temporary
Job description

A QC Compliance Specialist is required by CareerWise Recruitment for our Waterford based pharmaceutical company. This is a 23-month contract. This is a hybrid position you can work 3 days on site and 2 days from home. If you have experience in QC bench equipment connectivity, CSV validation and compliance then this is the position for you !!!

THE ROLE

  • Review and approve validation documentation including protocols, reports, risk assessments, and traceability matrices within pre-defined timelines
  • Coordinate the development of validation quality documents ensuring regulatory compliance
  • Document and manage deviations, non-conformances, and corrective actions with proper evaluation
  • Raise and coordinate Change Control Requests (CCRs) for project work, ensuring proper documentation and regulatory impact assessment
  • Ensure regulatory compliance with FDA, EMA, and company quality standards across all validation activities
  • Proven experience in validation and qualification activities within pharmaceutical or biotechnology industry
  • Hands-on experience in Quality Control operations and laboratory environments
  • Knowledge of QC bench equipment and connectivity systems
  • Strong regulatory knowledge of FDA, EMA guidelines related to validation and qualification
  • Proficiency in preparing validation documentation including protocols, reports, and compliance records
  • Experience with change control processes and deviation management
  • Knowledge of risk assessment methodologies and traceability requirements
  • Experience with connectivity compliance systems in pharmaceutical manufacturing Knowledge of computerized systems validation (CSV) principles
  • Familiarity with calibration management and metrology practices
  • Experience working with external suppliers and contractors

REQUIREMENTS:

  • Minimum 2-5 years of industry experience in QC validation and quality systems
  • Strong foundation in pharmaceutical/biotechnology quality control operations
  • QC bench equipment connectivity, validation, and compliance

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QC Validation Specialist • Kingston, ON, Canada

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