Hire Ravi Chinchalkar, a pharma consultant specializing in FDA Inspections, Pharmaceutical Manufacturing 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: Ravi Chinchalkar is an experienced pharmaceutical Quality professional and GMP auditor with over two decades of expertise across GMP Audit, Third Party GMP Audit, Quality Management System, Deviations, Supplier Qualification, FDA Inspection Readiness, FDA Warning Letter Remediation, Process Validation, and Cleaning Validation. His career has been strongly focused on API manufacturing and quality operations, including failure investigations, OOS/OOT management, CAPA, regulatory remediation, vendor qualification, audit readiness, process validation, cleaning validation, risk assessment, and QMS implementation. He has worked with organizations including Lupin, Orchid Pharmaceuticals, PharmaZell, Dr. Reddy’s, and RA Chem Pharma and has independently supported numerous API and intermediate manufacturers through supplier audits, mock audits, compliance assessments, regulatory remediation, and quality-system improvement. His experience also includes working at USFDA Warning Letter sites, supporting EDQM and USFDA remediation projects, overseeing API CMOs, and conducting international supplier audits for regulated markets. - Show More
Ravi has direct experience with cleaning-validation programs within API manufacturing environments. His consulting materials specifically list cleaning validation among his core expertise and include it within GMP system setup services alongside process validation, water-system validation, equipment qualification, and facility qualification.
Ravi has strong expertise in pharmaceutical failure investigations, particularly deviations, OOS, OOT, market complaints, root-cause assessment, and CAPA effectiveness. At Dr. Reddy’s, he led investigations and remediation activities and worked extensively on improving investigation quality at regulatory-challenged sites. He can support organizations in developing scientifically sound investigations, identifying root causes, strengthening documentation, and implementing effective corrective and preventive actions.
Ravi supports pharmaceutical organizations with USFDA inspection readiness through mock audits, gap assessments, remediation planning, investigation review, QMS strengthening, and pre-audit compliance assessments. He has worked extensively in regulatory-challenged environments and has experience helping sites maintain continuous audit readiness and respond effectively to regulatory findings.
Ravi has direct experience working at USFDA Warning Letter sites and supporting remediation and compliance initiatives involving both USFDA and EDQM concerns. His background includes investigation improvement, CAPA development, QMS remediation, compliance-gap assessment, and collaboration with specialist remediation consultants to address significant regulatory deficiencies.
Ravi has extensive experience conducting GMP audits, compliance assessments, and internal gap assessments across API manufacturing and testing environments. His consulting practice includes GMP audits of API and intermediate manufacturers, mock audits, SOP-versus-practice assessments, audit-readiness reviews, and identification of GMP deficiencies. He can support organizations in identifying compliance risks and developing practical actions to strengthen sustainable GMP performance.
Ravi has substantial API process-validation experience, including responsibility for the lifecycle management of more than 50 API products and validation from R&D scale through commercial manufacturing. His experience includes validation strategy, protocol and report review, technology-transfer documentation, facility readiness, and supporting compliant implementation of API manufacturing processes.
Ravi has extensive experience establishing, implementing, reviewing, and improving pharmaceutical Quality Management Systems, particularly within API manufacturing operations. His background includes SOPs, CAPA, investigations, deviations, audit observations, risk assessments, batch-release support, QMS documentation, and implementation of quality systems in new and existing facilities. He can support organizations in identifying weaknesses in existing QMS processes and implementing practical improvements aligned with regulatory expectations.
Ravi has substantial experience qualifying and auditing API, KSM, intermediate, excipient, CMO, and other pharmaceutical suppliers. His consulting work includes supplier quality-system assessments, audit planning, audit-report preparation, CAPA management, risk assessment, and vendor qualification for both clinical-trial and commercial supply.
Third-party auditing is one of Ravi’s strongest differentiating capabilities. His audit log documents more than 150 recent assignments involving APIs, advanced intermediates, KSMs, clinical-trial facilities, packaging materials, and finished dosage operations, with Ravi serving predominantly as Lead Auditor for clients across multiple international markets. He also reports more than 300 additional audits completed during his industry career.
