QA Compliance Specialist (Part Time)

Added
19 days ago
Type
Part time
Salary
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Related skills

risk management validation supplier quality fmea capa
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๐Ÿ“‹ Description

  • Coordinate and maintain the site Quality Management System, ensuring compliance with AbbVie
  • Lead and support Product Quality Review (PQR) activities.
  • Manage technical agreements, including initiation, review, approval, implementation, and document
  • Coordinate quality metrics, track-and-trend activities, and performance reporting to support
  • Drive the application of Quality Risk Management (QRM) principles across site activities, including
  • Support investigations of customer complaints, deviations, and non-conformances, ensuring robust

๐ŸŽฏ Requirements

  • Third-level qualification in Science, Quality, Engineering, or a related discipline.
  • Minimum of 2 years' experience in a Quality Assurance, Quality Compliance, or related GMP
  • Strong knowledge of cGMP requirements and pharmaceutical regulatory expectations.
  • Experience working within a Quality Management System in a regulated manufacturing environment.
  • Experience supporting regulatory inspections and audits (preferred).
  • Knowledge of quality risk management, change control, CAPA, supplier quality, and validation
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