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Bora PharmaceuticalsPosted 2 weeks ago

QA Compliance Specialist

$68,000–$85,000 year

On-siteMississauga, Ontario, Canada

Full TimeBachelors DegreeLarge

Job Summary

Plan and manage compliance requirements for a complex mix of products for global markets, providing quality support for project transfers and initiatives. Issue or approve critical quality documents including Master Data, Standard Operating Procedures, Technical Reports, and Quality Agreements. Analyze processes to identify gaps, establish remediation plans, and lead implementation activities while managing supplier assessments and responding to quality alerts. Lead investigations using root cause analysis tools to develop CAPA plans and actively participate in inspections and internal audits. Support Drug Establishment Licence Management and contribute to cGMP training, with a fixed-term contract of 18 months at $68,000–$85,000.

Required Qualifications

  • Bachelor of Science degree or College Diploma in a science related field
  • Minimum 5 years experience in a similar Quality related role within the pharmaceutical or related industry
  • In-depth knowledge and understanding of global GMP requirements
  • Demonstrated understanding of the regulatory framework and current industry standards
  • Knowledge of pharmacopeia requirements and processes
  • Understanding of risk management principles
  • Flexibility with Onsite Work Schedule and Occasional Extended Hours

Desired Qualifications

  • Computer proficiency and proficiency in Microsoft Office applications and the ability to quickly adapt to working with new electronic systems

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