Hire Sachin Shah, a pharma consultant specializing in FDA Inspections, Medical Devices 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: Sachin Shah is an independent GMP and quality systems auditor with experience across pharmaceutical quality assurance, quality control, API and formulation manufacturing, packaging, and analytical laboratories. His expertise includes GMP audits, third party GMP audits, supplier qualification, FDA inspection readiness, mock FDA inspections, and quality management system assessments. He also supports GMP compliance, quality assurance documentation, and corrective and preventive action review. He has completed ISO 9001:2015 Auditor/Lead Auditor training and ISO/IEC 17025:2017 laboratory systems and internal audit training. Through risk-based assessments, evidence-based reporting, and audit follow-up, he helps pharmaceutical organizations identify compliance gaps, strengthen documentation, and prepare their quality systems for regulatory inspections. - Show More
Sachin supports pharmaceutical CAPA processes through audit finding classification, root cause analysis review, and assessment of proposed corrective and preventive actions. He evaluates whether actions address the identified issues and reviews evidence supporting their closure. His structured follow-up helps organizations strengthen responses to audit findings and quality system deficiencies.
Sachin supports FDA inspection preparation through GMP gap assessments, documentation reviews, and self-inspection activities. His work includes evaluating pharmaceutical quality systems, laboratory practices, electronic records, and data integrity controls against applicable requirements. He helps organizations identify areas requiring attention and review corrective actions before regulatory inspections.
Sachin conducts GMP audits of API, formulation, packaging, and pharmaceutical laboratory facilities. His assessments cover manufacturing practices, quality systems, documentation, and laboratory controls against applicable EU GMP, US FDA, and ICH Q7 requirements. He provides evidence-based audit findings and supports follow-up reviews to assess how identified compliance gaps have been addressed.
Sachin supports GMP compliance through assessments of manufacturing facilities, laboratories, and pharmaceutical quality documentation. His experience includes reviewing practices against EU GMP, ICH Q7, and applicable US FDA requirements. He also evaluates data integrity and documentation controls, helping organizations identify compliance gaps and review the effectiveness of corrective measures.
Sachin conducts mock inspection and self-inspection audits to assess preparedness for FDA inspections. His reviews cover manufacturing operations, quality systems, laboratory controls, and documentation practices within the agreed audit scope. He reports identified gaps and supports corrective action follow-up to help site teams strengthen their inspection readiness.
Sachin provides quality assurance support through review of specifications, analytical procedures, quality records, and technical documentation. Drawing on his pharmaceutical QA and QC background, he assesses documentation practices and their alignment with established quality requirements. His work helps organizations improve record consistency, traceability, and readiness for quality audits.
Sachin assesses pharmaceutical quality management systems through system audits and reviews of quality procedures and records. His experience includes ISO 9001:2015 audits, deviations, change control, CAPA, and quality risk management. He helps organizations identify weaknesses in their quality processes and establish practical priorities for system improvement.
Sachin supports supplier qualification through risk-based assessments, qualification documentation review, and supplier audits. His experience includes onboarding and periodic requalification of API, excipient, packaging material, and contract manufacturing suppliers. He helps pharmaceutical organizations evaluate supplier quality systems, identify compliance concerns, and review actions taken in response to audit findings.
Sachin provides independent third party GMP audits of suppliers, contract manufacturers, and external testing laboratories. His experience covers API, excipient, packaging material, CMO/CDMO, and CRAMS facilities. He evaluates quality practices, documents observations, and reviews subsequent corrective actions to help clients assess the compliance of their external manufacturing and testing partners.
