Gaurav Walia, M.S., is a pharmaceutical consultant – consent decree/computer systems validation. He has most recently worked on three major consent decree projects with McNeil/Johnson & Johnson (CSV), Novartis (third party manufacturing assessment), and b. Braun (CSV, overall QA and compliance, audits). Overall, Mr. Walia has over 19+ years of pharmaceutical experience with careers at Monsanto/Searle, Pfizer/Oread, Forest Laboratories, etc., while also serving as a pharmaceutical consultant in various disciplines from quality systems, consent decree, computer systems validation, etc.
His career is filled with a multitude of experience since his days as an analytical R&D chemist to assistant director of pharmaceutical operations to director of quality assurance and compliance. Mr. Walia has managed various technical, quality and compliance groups, such as but not limited to, pharmaceutical research and development, laboratory information management systems (LIMS), metrology, quality control (QC), computer systems validation (CSV), materials import and export, safety, new facility design, validation and commissioning, quality assurance and compliance, capital budget (instrument and equipment acquisition from R&D to commercial, operating budget (all service contract including vendor certifications and agreements), regulatory compliance, etc.
Concurrently, Mr. Walia’s diverse multi-disciplined background has yielded years of success towards internal audit excellence, successful remediation projects, as well as over 100+ regulatory audits both domestic (FDA) and international (sFDA/Chinese FDA, EMEA, IMB, etc.) which in total were successful inspectional audits.
Overall, Mr. Walia’s career has not only spanned across the globe but has also traveled across many different key pharmaceutical disciplines as well as products such as liquids, solids, patches, crèmes, antibiotics/aseptic processes, medical device, biologics, etc. while also covering nutritional, OTC, generic and proprietary/branded products.