Hire Durgesh Srivastav, a pharma consultant specializing in Analytical Testing 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: Durgesh Srivastav is an experienced pharmaceutical Quality Control and Quality Management professional with a career spanning more than two decades across tablets, capsules, injectables, ophthalmic preparations, ointments, and liquid dosage forms. His expertise includes analytical testing, QC laboratory operations, Quality Management Systems, analytical method validation, deviations, OOS/OOT investigations, change control, data integrity, product complaints, SOP and specification development, GMP/GLP compliance, and inspection preparedness. He has also supported pharmaceutical quality-system and laboratory setup activities, including water-system validation, microbiology laboratory establishment, procurement of QC instruments, development of laboratory teams, and implementation of documentation systems. His extensive QC leadership experience enables him to support pharmaceutical organizations with analytical quality, laboratory compliance, investigation management, quality-system improvement, training, and regulatory readiness. - Show More
Durgesh supports pharmaceutical organizations with the investigation and management of deviations and laboratory quality events. His experience includes deviations, OOS/OOT investigations, analytical troubleshooting, corrective actions, and documentation review. He can help organizations identify potential root causes, establish appropriate action plans, improve investigation quality, and strengthen controls intended to prevent recurrence.
Durgesh supports pharmaceutical organizations with GMP and GLP compliance, particularly within Quality Control and laboratory operations. His experience includes Schedule L compliance, QMS implementation, data integrity, SOPs, documentation systems, investigation management, and hosting cGMP/GLP inspections. He can assist organizations in identifying compliance gaps, strengthening laboratory practices, and improving inspection preparedness.
Durgesh supports analytical method validation through his experience with Analytical Method Validation (AMV), standard testing procedures, specifications, and technology-transfer activities. His QC background enables him to assist with the review and implementation of analytical methods, validation documentation, testing procedures, and method-related laboratory controls to help ensure reliable and compliant analytical performance.
Durgesh brings extensive leadership and hands-on experience in pharmaceutical Quality Control operations. He has managed QC functions across multiple pharmaceutical organizations and dosage forms, overseeing laboratory testing, quality standards, analytical activities, documentation, investigations, and team performance. He can support organizations with QC laboratory management, workflow improvement, analytical oversight, documentation systems, and laboratory compliance.
Durgesh has extensive experience managing Quality Management Systems within pharmaceutical QC operations. His responsibilities have included deviations, OOS/OOT investigations, change control, data integrity, complaints, SOPs, specifications, quality procedures, documentation control, and regulatory inspection responses. He can support organizations in evaluating QMS effectiveness, identifying system gaps, strengthening quality processes, and improving overall regulatory readiness.
