Qualified Person

Role Purpose

The role of Qualified Person (QP) primarily involves ensuring the quality and compliance of BCL pharmaceutical products, particularly in manufacturing and release. The QP is legally responsible for certifying that each batch of a medicinal product meets all required quality standards before it can be released for market and handling all the related product investigations.

the QP acts as a safeguard, ensuring that pharmaceutical products are safe, effective, and meet the required quality standards throughout their lifecycle.

Job Accountabilities & Activities

• Perform Batch Release Review and Certifications:
  
  

The QP is responsible for reviewing batch manufacturing records of BCL products that meet all quality requirements before it is released for distribution and complete the related batch release certificates in the GME - ERB system.

• Ensure Compliance with SFDA and Vantive Regulations: The QP is responsible for ensuring that the manufacturing processes adhere to Good Manufacturing Practices (GMP) and other relevant SFDA regulatory standards.
• Maintain Quality System NCR & CAPAs: The QP is responsible for handling the overall quality system for product Nonconformances investigations and related Corrective actions in Trackwise system.
• Maintain Quality System Complaints and FA: The QP is responsible for handling the overall quality system for product Complaints and FA investigations and related Corrective actions in Trackwise system
• Maintain Supplier Management System SQLM: The QP is responsible for handling Supplier Quality Management Life Management for the compliance of an BCL approved suppliers in Trackwise system.
• Handling External and Internal Audits: The QP is responsible for handling the External Audits for Product release, Complaints and SQLM, also participating in GEMBA walks and Internal Audits for all operational areas.
• Control Quality Restricted Areas: The QP is responsible for control Quality restricted areas (HOLD, Quarantine, Recall, Return, file samples and Reject).
  
  

Education & Certifications

Bachelor of Pharmacy.

Required Years Of Experience

3 -5 years or more relevant experience in pharmaceutical plants.