Shambhavi Bangera

At Solara Active Pharma Sciences, I manage API quality work across validation, audit management, and quality records. I draft, review, and approve validation protocols and reports, including process validation, performance qualification, and cleaning validation.

I handled end-to-end audit management, hosting customer audits alongside USFDA and EDQM inspections, and writing responses and tracking CAPAs. I also manage Change Control, CAPA, and deviation workflows in TrackWise.

My work at Solara includes shop-floor quality activities, BMR reviews, and Annual Product Quality Reviews. I also validated Excel spreadsheets for computer system validation and data integrity, and provided technical documentation and data support for DMF filings.

At Syngene International, I contributed to Greenfield commissioning and QA readiness, reviewed equipment qualification packages, and managed LMS operations. I also supported audits, QMS lifecycle management, site archival qualification, and regulatory documentation for DMF submissions.