Ravinder Kanger Email & Phone Number

Quality driven individual with 9+ years of experience in the cGMP environment with specialization in Quality Assurance, technology transfer, eQMS Validation, process/manufacturing equipment validation, computer system validation human drug validation. Well-versed with FDA 21 CFR part 210 and 211, Health Canada GUI-001, 21 CFR part 11 and GAMP, Master Control and ZENQMS.•Extensive experience in development and writing of quality systems, technology transfer documents, cleaning, and process validation protocols and protocols for cGMP facility following GDP (Good Documentation Practices)•Member of a leadership team that managed GMP readiness for a start-up pharmaceutical manufacturing facility which resulted in a “zero” 483 audit for initial facility GMP/GLP certification and 1st PAI. •Well-versed with FDA 21 CFR part 210 and 211 guidelines.•Experience in Change management Change control management, deviation handling, Corrective and preventive action (CAPA), risk assessment, issue management, and communication plan.•Develop and participate in annual product review, and quality management review.•Experience in risk assessment through the failure modes and effects analysis (FMEA)•Proficient in writing standard operating procedures (SOPs) for the operation of production equipment, and Occupational Safety and Health Administration (OSHA) requirements•HACCP and PCQI certified individual.•Proficiency in using MS Project, Zen-QMS, MS Office Suite, Visio software, MS teams, Web-Ex.

Listed skills include Food Safety, Food Processing, Food, Food Industry, and 23 others.