Job Description

Description


 

Qualified Person


Job Responsibilities:

  • Complies with the responsibilities of Qualified Person (QP) stated in directives issued by EC.
  • Certifies batches for sale or supply in compliance with regulations.
  • Approves Annual Product Quality Review, SOPs, Complaint investigations, Deviations (EQMS general investigations).
  • Attends and participates Event Review, Quality Systems Review and Site QP Meetings
  • Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
  • Participates in writing or suggesting changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed to ensure defined quality objectives are met.
  • Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
  • Reviews manufactu...

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