Tasks

  • Responsible for Analytical Development and Quality control for assigned combination device (DP Filing Stage)
  • Organize laboratory activities in alignment with established guidelines and SOPs
  • Develop, optimize, and implement analytical methods for various applications
  • Lead the documentation and review of method development, validation, and implementation
  • Lead laboratory investigations to address product/process issues, deviations, CAPA, and complaints

Qualifications

  • Proven expertise in analytical method development, validation, and implementation (with a focus on HPLC and GC)
  • Strong understanding of GMP, GLP, GDP, and regulatory requirements for drug development
  • Excellent organizational and communication skills
  • Experience in managing cross-functional projects and collaborating with external partners
  • Familiarity with regulatory submissions and health authority interactions