Divya Gali

Background

About Divya Gali

I am a Quality Assurance & Quality Control Microbiologist with 6+ years of experience in pharmaceuticals, natural health products, dietary supplements, cosmetics, cannabis, and packaging industries. Skilled in GMP, GDP, CAPA, Change Control, Risk Assessment, Deviation Management, and LIMS, I specialize in ensuring compliance with USP, EP, IP, Health Canada, WHO, and ISO guidelines while supporting both sterile and non-sterile environments. My expertise spans microbial limit testing (MLT), preservative efficacy testing (PET/AET), method development for probiotics & Bacillus species, water sample testing, and environmental monitoring. I have successfully contributed to regulatory, client, and internal audits (WHO, NABL, Health Canada) with a strong track record of maintaining compliance and quality excellence. To strengthen my regulatory and technical expertise, I have recently completed certifications in: • CMC and Regulatory Challenges for Oligonucleotide Drugs • Current CMC Regulatory Experiences and Expectations for Oligonucleotides • Interlaboratory Comparison of Benchtop NMR Spectrometers • Medical Devices Standards and Classifications: Focus on Maternal, Neonatal and Child Health (MNCH) • PCM and Regulatory • Regulatory Considerations for Setting Smart Starting Material Specifications • The Medicines Risk-based Surveillance (MedRS) Tool for Post-Marketing Surveillance • USP Certificate of Document and Reference Standards