Gaurav WaliaPrincipal Computer Systems Validation at PQE GroupSpeaker
Profile
Gaurav Walia, MS is a long tenured employee of the Pharmaceutical Industry with some experience as well in Medical Device. Overall, Mr. Walia has over 25+ years of pharmaceutical experience with careers at Monsanto/Searle, Pfizer/Oread, Forest Laboratories, Mylan ,etc., while also serving as a pharmaceutical consultant for over the last 10 years in various disciplines from quality systems, consent decree, computer systems validation, etc. Mr. Walia has three Consent Decrees under his belt focusing on CSV. Mr. Walia’s more recent specialties over the last 10 years have focused on Consent Decree, Computer Systems Validation and Data Intergrity.
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 and regulatory compliance.
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.