Priya User

I've supported GxP compliance, audit activities, and Quality Management System documentation at Biological E Limited, helping maintain readiness against FDA/EMA regulatory standards.

I reviewed manufacturing, laboratory, and quality records against ALCOA+ data integrity principles and contributed to CAPA tracking, deviation trending, SOP readiness, and audit documentation.

I also participated in Contamination Control Strategy assessments, reviewing cleanroom practices, HEPA monitoring logs, and gowning compliance records. I prepared audit summaries, dashboards, and compliance presentations for management review.

Earlier, at Mankind Pharma and Excel Hospital, I supported quality-control documentation, GMP recordkeeping, medication dispensing, inventory documentation, and expiry tracking. I'm pursuing a Master of Pharmaceutical Quality Assurance and looking to contribute in regulatory affairs, compliance, or quality systems.