Sagar Sonawala

I’m a sterile pharmaceuticals microbiology leader with nearly 17 years of experience in sterile injectables and ophthalmics for US and EU markets. I act as a designated primary Microbiology SME across high-stakes regulatory expectations, including USFDA, EU GMP, MHRA, TGA, ANVISA, and WHO.

In my current role as Deputy Manager – Microbiology at Alembic Pharmaceuticals Ltd., I lead microbiology and environmental monitoring programs with full QMS ownership—OOS, OOT, APS failures, EM excursions, deviations, change control, and CAPA. I’ve built repeatable, audit-ready approaches such as a weekly FDA 483 intelligence review programme and risk-driven EM assessments that keep the site ahead of inspection trends.

My work has been inspection-proven. I led microbiological response to USFDA 483 observations (Feb 2026) by compiling three-year raw EM data across Grade A/B areas, preparing glove port impact assessment using historical monitoring, and authoring a risk assessment supporting revised ambidextrous glove monitoring procedure included in site CAPA submission. I’ve also achieved zero microbiology 483 observations in the most recent USFDA inspection (Feb 2026).

I bring both technical depth and team leadership, directly leading a team of 11 within a 30-person microbiology department (and supporting a 20-person EM team). Alongside complex Grade A contamination investigations (including Gemba Walk and microbial ecology analysis), I contribute to EU GMP Annex 1 CCS through ownership of the Monitoring System and outsourced activities framework, and I’m a qualified internal and vendor auditor spanning QC, Manufacturing, Packing, Warehouse, and suppliers.