Hire Amit K Mishra, a pharma consultant specializing in 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: Amit K. Mishra is a GMP auditor and quality consultant with 25+ years of experience in pharmaceutical quality, analytical operations, and regulatory compliance. His expertise includes GMP audits, gap assessments, CAPA review, quality system evaluation, laboratory compliance, and audit readiness across APIs, intermediates, formulations, medical devices, and cosmetics. He brings strong hands-on experience in supporting organizations with practical compliance improvements, risk-based audit programs, remediation planning, and quality oversight aligned with EU GMP, US FDA, ISO, and related regulatory expectations. - Show More
Amit supports FDA inspection readiness by helping organizations strengthen audit preparedness, improve documentation quality, and address compliance gaps before regulatory review. His experience includes conducting GMP audits under major regulatory frameworks, reviewing corrective action plans, preparing gap analysis reports, supporting remediation activities, and guiding teams on quality and compliance expectations. He also brings strong practical understanding of investigations, CAPA, laboratory controls, quality oversight, and risk-based audit strategy, helping organizations move toward a more inspection-ready and defensible compliance position.
Amit supports GMP audits across regulated manufacturing and quality environments, helping organizations assess compliance, identify gaps, and strengthen inspection and audit readiness. His experience includes leading and facilitating GMP audits for APIs, intermediates, formulations, cosmetics, medical devices, laboratories, suppliers, warehouses, and contract manufacturing environments. He also supports audit reporting, CAPA review, triggered audits, vendor qualification, and follow-up actions, bringing a practical and risk-based approach that helps organizations improve quality systems, address compliance concerns, and maintain stronger operational control.
Amit supports GMP compliance by helping organizations evaluate existing systems, identify improvement areas, and implement practical actions that strengthen quality and regulatory alignment. His work includes cGMP consultation, gap analysis, quality system review, risk-based assessments, policy and procedure guidance, laboratory compliance, vendor oversight, and support for continuous improvement initiatives. With experience across multiple regulated product categories, he helps organizations build and maintain compliance-focused operations that are practical, sustainable, and aligned with current regulatory and quality expectations.
