Hire Gaurav Kaushik, a pharma consultant specializing in FDA Inspections, Pharmaceutical Manufacturing, Pharmaceutical Quality and Sterile Manufacturing. See services offered, experience summary, and connect via apicule.
Based in: India
Willing to work in: Global
Consultant Type: Independent Consultant
Expertise summary: Gaurav Kaushik is an independent pharmaceutical quality and compliance consultant with nearly 23 years of experience across pharmaceutical and biotechnology operations, including sterile formulations, monoclonal antibodies, and vaccines. His expertise includes GMP auditing, supplier qualification, FDA inspection readiness, quality management systems, aseptic manufacturing, equipment qualification, and sterility assurance. He has held quality leadership positions with Shilpa Biologicals, Zydus Lifesciences, Panacea Biotec, and other pharmaceutical organizations. His experience includes approximately 40 supplier and manufacturer audits and the review of more than 100 audit reports. Gaurav supports manufacturers through compliance gap assessments, inspection preparation, contamination control strategies, and quality system improvements, alongside technical support for new facilities and expansion projects. - Show More
Gaurav supports aseptic manufacturing operations for sterile pharmaceuticals and biotechnology products, drawing on experience with vials, prefilled syringes, and ampoules. His work includes reviewing aseptic practices, media fill protocols and reports, manufacturing documentation, and contamination control measures. He helps teams assess operational risks and strengthen procedures for aseptic processing, supported by experience across sterile formulations, monoclonal antibodies, and vaccines.
Gaurav provides qualification support for pharmaceutical manufacturing equipment and critical utilities. His experience includes HVAC systems, water systems, high-pressure high-vacuum sterilizers, lyophilizers, filling and sealing machines, fermenters, and isolators. He reviews qualification protocols, validation master plans, and associated documentation, helping manufacturers establish qualification activities appropriate to equipment use and manufacturing requirements.
Gaurav supports pharmaceutical and biotechnology sites in preparing for FDA inspections through gap assessments, documentation reviews, and evaluation of manufacturing and quality practices. His background includes leading site readiness activities and managing regulatory inspections, with experience facing two US FDA inspections. He helps teams identify deficiencies, prioritize corrective actions, and prepare relevant records and quality systems for inspection.
Gaurav conducts GMP audits and compliance gap assessments for pharmaceutical and biotechnology operations. His experience covers internal audits and self-inspections across quality systems, manufacturing, engineering, and supply chain functions. Drawing on regulatory and customer inspection experience, he assesses procedures, records, and operational practices, identifies non-conformances, and supports corrective actions to address compliance gaps.
Gaurav helps pharmaceutical manufacturers strengthen GMP compliance through the review of site practices, SOPs, quality documentation, and manufacturing controls. His work includes data integrity assessments, quality risk assessments, and improvements to compliance monitoring. He also supports new facilities and expansion projects by reviewing facility layouts, personnel and material flows, and technical documentation from a GMP perspective.
Gaurav supports the establishment, implementation, and improvement of pharmaceutical quality management systems. His experience covers change control, deviations, OOS investigations, complaints, recalls, CAPA, and quality risk management, including electronic quality systems. He also helps organizations develop quality metrics, management review processes, SOPs, and action-tracking mechanisms to strengthen oversight and support consistent quality performance.
Gaurav supports sterility assurance programs for sterile pharmaceutical and biotechnology manufacturing. His experience includes developing contamination control strategies, reviewing media fill protocols and reports, assessing aseptic practices, and overseeing sterilization-in-place and cleaning-in-place activities. He helps manufacturers evaluate contamination risks and strengthen the procedures, validation documentation, and operational controls that support product sterility.
Gaurav supports supplier and manufacturer qualification through vendor identification, audit-based evaluation, performance monitoring, and requalification. His experience includes approximately 40 supplier and manufacturer audits, covering API and other material suppliers, alongside the review of more than 100 audit reports. He helps organizations assess supplier quality risks, review quality agreements, and manage supplier changes and quality concerns.
Gaurav provides independent GMP auditing support to help pharmaceutical companies assess external suppliers and manufacturing partners. His background combines freelance auditing assignments with extensive supplier quality management experience. He reviews relevant quality systems, manufacturing controls, and supporting documentation to identify gaps and provide findings that inform supplier oversight, corrective action planning, and ongoing compliance assessments.
