Hire Kanchan Roy, a pharma consultant specializing in Anlaytical Testing, FDA Inspections, Medical Devices and Pharmaceutical Manufacturing. See services offered, experience summary, and connect via apicule.
Based in: India
Willing to work in: India
Consultant Type: Independent Consultant
Expertise summary: Kanchan Roy is a pharmaceutical quality assurance and regulatory affairs consultant with over 32 years of experience across formulation manufacturing, quality systems, validation, documentation control, and regulatory compliance. His background spans oral liquids, tablets, ointments, injectables, and ORS powders, with deep hands-on involvement in QA operations, IPQA, batch documentation, site quality systems, equipment and utility qualification, process and analytical method validation, and audit readiness. He brings strong practical knowledge of GMP, WHO GMP, USFDA-facing environments, CDSCO and Schedule M requirements, and third-party manufacturing oversight, making him well suited for compliance-focused and execution-driven consultancy assignments. - Show More
Kanchan supports analytical development through strong hands-on familiarity with pharmaceutical quality control systems, testing workflows, analytical instruments, and documentation practices required in regulated formulation environments. His experience includes oversight of analytical method validation, technical understanding of instruments such as HPLC, FTIR, UV-visible spectrophotometry, Karl Fischer titration, viscometry, and related chemical and instrumental testing methods used in pharmaceutical and chemical divisions. He helps organizations strengthen analytical quality support by aligning method execution, documentation, and validation practices with GMP expectations and operational requirements.
Kanchan supports CAPA activities through his broader quality assurance and operational QA experience in regulated formulation manufacturing. His profile highlights direct involvement in quality systems, risk assessments, change control, IPQA activities, documentation oversight, and audit-facing quality operations, which are central to identifying quality gaps and driving corrective and preventive actions. He helps organizations strengthen follow-up systems, improve procedural discipline, and support more sustainable quality compliance by linking investigations, documentation control, and operational quality improvements in a practical manufacturing setting.
Kanchan supports equipment qualification with strong experience in validation and qualification of pharmaceutical equipment and associated systems within regulated manufacturing sites. His resume specifically highlights work on instrument and equipment validation, including DQ, IQ, OQ, and PQ activities, along with calibration records and oversight of machinery used across formulation manufacturing operations. He helps companies establish and maintain qualification practices that support equipment reliability, process consistency, proper documentation, and audit readiness across production and quality systems.
Kanchan supports facility qualification through practical experience in utility and environment-related validation activities essential to pharmaceutical manufacturing compliance. His work includes validation of water systems such as PW, WFI, and DW, air systems including HVAC and AHU, and related quality documentation needed to support controlled manufacturing conditions. He helps organizations strengthen qualification programs for critical facility systems by linking technical execution with GMP documentation, regulatory expectations, and operational control across formulation units.
Kanchan supports FDA inspection readiness by helping formulation sites strengthen their quality systems, documentation discipline, validation practices, and audit preparedness. His background includes facing GMP, WHO GMP, USFDA, ISO, and international audits, along with experience in implementing site quality documentation, validation systems, and manufacturing records across multiple dosage forms. He helps organizations improve compliance readiness by ensuring that procedures, records, and quality operations are better aligned with regulatory expectations and inspection-level scrutiny.
Kanchan supports method validation through practical experience in both analytical and manufacturing method validation within regulated pharmaceutical environments. His resume specifically mentions analytical method validation and manufacturing method validation, supported by strong familiarity with major QC instruments and testing methods across pharmaceuticals and chemicals. He helps companies improve method robustness, documentation quality, and validation discipline so that technical procedures remain reproducible, compliant, and well-supported during audits and regulatory review.
