Raavi Chati Email & Phone Number

- Developed and implemented quality systems, procedures, guidelines for regulatory compliance- Led internal and supplier quality audits, oversaw CAPA and change control processes- Managed teams of 16 quality control analysts and specialists- Authored SOPs, QA protocols, inspection readiness plans, training programs- Strong knowledge of ISO, GMP, GLP, GDP, GCP standards and FDA/EMA regulations - Subject matter expert in defect prevention, complaint handling, deviations, OOS results- Experience with statistical analysis, trending, reporting of quality data - Led responses and corrective actions during regulatory inspections- Implemented QA infrastructure, procedures, and training programs for a start-up biotech company - Led integration and streamlining of quality systems after an acquisition- Strong working knowledge of risk management frameworks and tools (FMEA, HAZOP, FTA, etc.)- Developed quality and performance metrics, dashboards, and reporting tools- Managed document control databases and change management processes- Authored validation protocols for equipment, computer systems, lab instruments- Extensive experience with CAPA, complaint, deviation, and OOS investigations- Led supplier qualifications, audits, and continuous improvement initiatives - Reduced product defect rates by 15% over 2 years through QA initiatives- Expertise in data integrity, record retention, and electronic documentation- Managed stability and product lifecycle management programs- Organized and hosted GMP training for staff across multiple sites- Skilled with QA management software and laboratory information systems

- Developed risk-based validation master plans and budgets ensuring efficiency and regulatory compliance- Managed validation teams of up to 15 engineers and specialists, overseeing execution of protocols - Authored equipment, process and computer system qualification protocols, test plans and reports - Maintained validation document traceability matrices and change controls- Led responses to regulatory audits and health authority inspections - Strong working knowledge of GMP, GLP, 21 CFR Part 11, Annex 11, GAMP5, ISO 13485- Subject matter expert in HPLC, autoclaves, lyophilizers, clean rooms, HVAC, lab equipment validations- Experienced with validation management software platforms and tools- Effective leadership, critical thinking, problem solving, and communication abilities- Continuing education insetCurrent Good Manufacturing and Validation Practices, data integrity

- Led process design, scale-up, troubleshooting, and optimization projects- Authored process flow diagrams, P&IDs, SOPs, batch records, protocols- Managed technology transfers and new product introductions- Conducted process capability and validation studies - Strong knowledge of unit operations - filtration, centrifugation, chromatography, etc.- Handled deviation investigations, CAPA implementation, change control- Skilled with process modeling, simulation, and statistical analysis- Experienced with MES, SCADA, DCS, and process control systems- Improved product yields by 20% through process optimization - Reduced unit operation cycle times by 30%