Hire Ram Subhash Narkar, a pharma consultant specializing in 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: Ram Subhash Narkar is an independent GMP auditor and quality consultant with 23+ years of experience across pharmaceutical quality management systems, compliance quality, operational quality, supplier quality, laboratory quality, regulatory interactions, and manufacturing quality. His background spans APIs, intermediates, regulatory starting materials, packaging materials, and broader quality system development in regulated environments. He brings strong hands-on expertise in GMP compliance, supplier and third-party audits, data integrity, investigations, training, and implementation of robust quality systems aligned with USFDA, MHRA, TGA, EU GMP, WHO, PIC/S, and related global expectations. - Show More
Ram supports GMP audits through a practical, risk-based approach built on deep experience across regulated pharmaceutical operations and supplier networks. His profile highlights extensive exposure to inspections by USFDA, MHRA, TGA, EU GMP, WHO, ANVISA, and other regulators, along with interactions in 250+ customer and certification audits. He also conducted 110+ QMS/GMP audits of domestic and overseas suppliers for KSMs, primary packaging materials, advanced intermediates, and APIs as part of a certified auditing group. He helps organizations identify compliance gaps, evaluate site readiness, strengthen quality systems, and improve inspection preparedness through audit programs that are both technically sound and operationally practical.
Ram supports GMP compliance by helping organizations design, implement, strengthen, and sustain quality systems that meet current global regulatory expectations. His experience includes building and executing quality systems aligned with ICH, EU GMP, PIC/S, 21 CFR, EudraLex, and related regulations, along with practical exposure to site quality leadership and compliance transformation. He helps companies improve procedural control, documentation discipline, investigation quality, data integrity practices, and broader compliance culture so that GMP requirements are embedded into daily operations rather than treated as audit-only expectations. His support is especially valuable for organizations looking to reduce recurring compliance gaps and build a stronger, inspection-ready quality foundation.
Ram supports supplier qualification through deep experience auditing and assessing domestic and overseas suppliers involved in KSMs, primary packaging materials, intermediates, and APIs. His Novartis QMS auditor certification and audit experience across 100+ supplier sites demonstrate strong capability in evaluating supplier quality systems, GMP performance, compliance maturity, and ongoing suitability within regulated supply chains. He helps organizations qualify new vendors, reassess existing suppliers, and strengthen supplier oversight through structured audit-based evaluations that reduce quality and compliance risk. His approach combines technical depth, regulatory understanding, and practical recommendations that support more reliable and inspection-ready supplier management programs.
Ram supports third-party GMP audits for external manufacturers, suppliers, and service partners involved in regulated pharmaceutical operations. His background includes auditing facilities across domestic and overseas locations, along with extensive exposure to customer audits, certification audits, and supplier qualification activities in highly regulated environments. He helps organizations assess third-party quality systems, identify critical compliance risks, and strengthen confidence in outsourced and external supply partners through clear, practical, and implementation-oriented audit observations. His experience makes him well suited for companies seeking stronger external oversight, better vendor governance, and more dependable compliance assurance across the wider supply chain.
