Key Responsibilities: · Conduct microbial testing of raw materials and environmental samples. · Perform sterility, endotoxin, and microbial limit tests in compliance with GMP guidelines. · Monitor cleanroom and production areas through environmental monitoring and trend analysis. · Investigate microbiological…
· Prepare, review, and submit DMFs/CTDs (USDMF, EDMF, CEP, etc.) for regulated and semi regulated markets · Maintain regulatory documentation and lifecycle management of submissions · Coordinate with R&D, QA, QC, and production teams to gather data for submissions ·…