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API (Applied Pharmaceutical Innovation)
GxP Quality Assurance Validation SpecialistAPI (Applied Pharmaceutical Innovation) • Toronto, Canada
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GxP Quality Assurance Validation Specialist

GxP Quality Assurance Validation Specialist

API (Applied Pharmaceutical Innovation) • Toronto, Canada
7 days ago
Job type
  • Full-time
Job description
Support pharmaceutical innovation as a GxP Quality Assurance Validation Specialist. Oversee validation and qualification processes while ensuring adherence to stringent regulatory standards such as EU Annex 11 and FDA guidelines.

In this role, you will serve as a crucial QA expert, guiding the validation of computerized systems and GMP processes. Your expertise will help maintain compliance and readiness for inspections, while fostering a culture of quality within cross-functional teams. You will actively engage in risk assessments and documentation reviews related to system validation.

Key Responsibilities: • Provide comprehensive QA oversight for validation activities • Assess compliance with cGMP and global regulatory standards • Act as a leading authority on validation approaches • Monitor and ensure data integrity for all systems • Lead and guide change control initiatives

Requirements: • Bachelor’s degree in a related discipline required • 3 years of experience in GxP validation • Familiarity with Health Canada and FDA regulations • Strong leadership and mentoring skills • Excellent communication and collaboration abilities

Apply your validation expertise to ensure top-tier quality assurance standards within a thriving pharmaceutical sector. #J-18808-Ljbffr
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GxP Quality Assurance Validation Specialist • Toronto, Canada

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