Hire Seru Usha, a pharma consultant specializing in Clinical Studies, FDA Inspections and Pharmaceutical Quality. See services offered, experience summary, and connect via apicule.
Based in: India
Willing to work in: Global
Consultant Type: Independent Consultant
Expertise summary: Seru Usha is a pharmaceutical quality control and quality management systems professional with over 12 years of experience in API manufacturing. Her expertise includes FDA inspection readiness, quality control, quality management systems, GMP compliance, deviation investigations, change management, complaints handling, GMP training, and regulatory filing support.
Usha supports pharmaceutical change management through experience managing change controls within manual processes and GMP Pro QMS. Her background includes controlled document updates and coordination across QC, QA, regulatory affairs, production, and warehouse functions. She helps teams maintain traceable change records and align related documentation with established quality system procedures.
Usha supports complaints handling through experience investigating complaints, assessing root causes, and coordinating associated CAPAs. Her work combines quality system management with cross-functional collaboration and documentation review. She helps teams maintain investigation records, connect findings with appropriate corrective actions, and track follow-up activities through the quality management system.
Usha supports FDA inspection readiness through documentation reviews, evidence verification, compliance gap assessments, and remediation tracking. She has led readiness activities and acted as a subject matter expert during regulatory and customer audits. She helps QC teams prepare inspection records and coordinates with QA, regulatory affairs, production, and warehouse teams to address identified gaps.
Usha supports GMP compliance through controlled document management, SOP lifecycle oversight, and review of laboratory documentation practices. Her experience includes version control, periodic document reviews, and application of good documentation and ALCOA+ principles. She helps teams identify documentation gaps, monitor compliance status, and maintain consistent records across laboratory and quality activities.
Usha provides training and guidance on good documentation practices, quality system procedures, audit readiness, and regulatory inspection preparedness. Her experience includes coaching laboratory team members and supporting analyst qualification and requalification. She helps teams understand documentation responsibilities and apply approved procedures consistently during routine operations and inspection preparation.
Usha supports pharmaceutical quality control through experience reviewing and approving specifications and test methods, supporting commercial batch release documentation, and coordinating laboratory compliance activities. Her responsibilities include monitoring instrument calibration, maintenance, and qualification schedules, alongside analyst qualification and requalification support. She helps QC teams maintain controlled records and consistent laboratory quality practices.
Usha supports pharmaceutical quality management systems through experience managing change controls, deviations, non-conformities, OOS/OOT investigations, and CAPA implementation using GMP Pro QMS. Her work includes tracking corrective actions and verifying their effectiveness. She helps teams coordinate quality events, maintain supporting documentation, and follow up on actions arising from investigations and audits.
Usha supports regulatory filing activities through experience assisting regulatory affairs teams with Drug Master File submissions and responses to regulatory queries. Her contribution focuses on QC documentation, specifications, test methods, and supporting quality records. She helps teams organize and review laboratory information required for submission preparation and query responses.
