Hire Rahul Bhanudas Unde, a pharma consultant specializing in Analytical Testing, 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: Rahul Bhanudas Unde is an independent pharmaceutical quality consultant with over 20 years of experience across quality assurance and quality control. His background covers APIs, key starting materials, oral solid dosage forms, liquid formulations, and injectables. His expertise includes GMP audits, GMP compliance, quality management systems, supplier qualification, analytical method validation, facility qualification, and stability programs. He also supports documentation improvements, computerized system validation, and data integrity remediation. His career includes roles with Kilitch Drugs, Alpha-Pharma, Baxter, Sai Life Sciences, Wockhardt, Harman Finochem, Encore Healthcare, and Alkem Laboratories. Drawing on laboratory, manufacturing, and corporate quality experience, he helps organizations strengthen quality systems and address compliance gaps. - Show More
Rahul supports facility qualification through experience with laboratory design, qualification, and validation at Baxter, alongside systems and facility qualification responsibilities at Sai Life Sciences. He contributed to establishing an analytical validation laboratory with electronic data compliance controls. He helps teams review qualification documentation and coordinate requirements for supporting systems, instrumentation, and laboratory operations.
Rahul supports GMP audits through experience conducting internal audits, auditing contract manufacturing sites, and providing freelance audit services. His background includes certification as an internal auditor for Sai Life Sciences’ API units and participation in regulatory and customer audits. He helps organizations assess procedures, manufacturing practices, and quality records to identify compliance gaps.
Rahul supports GMP compliance through assessments of operating procedures, documentation practices, computerized systems, and data integrity controls. His consulting experience includes cGMP support, SOP preparation, and data integrity remediation. He has also worked on quality system improvements aligned with revised Schedule M and WHO guidelines, helping teams translate compliance requirements into practical operating procedures.
Rahul supports analytical method validation through hands-on API validation experience and subsequent quality assurance review of validation protocols and reports. His background also includes analytical method transfer and review of method development documentation. He helps laboratory and quality teams assess validation records and coordinate method transfer activities with established quality procedures.
Rahul supports pharmaceutical quality assurance through experience reviewing and approving manufacturing records, SOPs, annual product quality reviews, and development documentation. His background includes in-process quality assurance, batch release oversight, technology transfer reviews, and SOP harmonization. He helps manufacturing and development teams strengthen documentation and maintain consistent quality practices across operations.
Rahul supports quality control operations through approximately ten years of laboratory experience testing raw materials, packaging materials, APIs, finished products, and stability samples. His work includes analytical record review, instrument calibration, analyst qualification, and laboratory investigations. He helps laboratories improve testing practices, sample management, and documentation using his experience with chromatographic and other analytical instruments.
Rahul supports the establishment, implementation, and improvement of pharmaceutical quality management systems. His experience covers change control, deviations, non-conformances, CAPAs, out-of-specification investigations, and management reviews. He has supported quality system activities across manufacturing sites and global business units, helping teams coordinate quality responsibilities and improve procedures and documentation.
Rahul supports pharmaceutical stability programs through experience managing stability chambers and samples, performing stability testing, and reviewing study documentation. His background spans API and formulation laboratories, including testing of finished products and stability samples. He helps laboratory and quality teams strengthen sample handling, analytical record review, and documentation of stability activities.
Rahul supports qualification of raw material and packaging material suppliers, service providers, and contract manufacturing partners. His experience includes vendor assessments, contract manufacturing site audits, and review of technical and quality agreements. He helps organizations strengthen supplier documentation and define quality responsibilities for externally supplied materials and outsourced activities.
