Quality Assurance & Compliance Project Manager

Responsibilities
Lea el resumen de esta oportunidad para comprender qué habilidades, incluidas las habilidades interpersonales relevantes y el dominio de paquetes de software, se requieren.

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• Manage, maintain, and improve Quality Management Systems (QMS) in compliance with GMP regulations and applicable regulatory requirements (EU GMP, FDA, ICH).
  
• Support clients in QMS implementation, remediation, and continuous improvement initiatives.
  
• Coordinate and implement Contamination Control Strategies (CCS) of Annex 1.
  
• Participate in internal audits, supplier audits, mock inspections, and regulatory inspections.
  
• Manage and support quality processes including, Deviations, CAPAs, Change Controls, Complaints, OOS/OOT investigations, Product Quality Reviews (PQR/APR), Batch Record Review, Documentation Management .
  
• Coordinate and support Validation activities , define validati...