Raghavendra Pai

Background

About Raghavendra Pai

Responsible for implementation of Quality Management System at Norwich Clinical Services which includes Quality Assurance of Bio-equivalence studies, Clinical trials, Pharmacovigilance Services and Validations.*Presently leading & mentoring the team of Quality Auditors and Validation team.*Overall more than 19 years of experience in Pharmaceutical industry out of which 15+ years of experience in managing Clinical Research Quality Assurance,*Development, and implementation of Quality Management Systems (QMS) including SOPs, Clinical Study Protocols, Reports (CSRs), Trial Master Files, Method validation reports, Study Sample analysis Reports, CAPA, Change Controls and Document Control.*Expert in auditing and ensuring compliance to international & national regulatory requirements including ICH efficacy guidelines including GCP, OECD series on principles of good laboratory practice (GLP) and compliance monitoring, Good Pharmacovigilance practices (GVP).*Hands-on experience in interacting with regulatory authorities and successfully handled regulatory inspections like USFDA, WHO, MHRA(UK), AFSSAPS, NPRA, DCGI, for Bioequivalence studies, Clinical trials, and Pharmacovigilance services.*Handled successfully inspection for path lab with respect to NABL & CAP accreditations.*Worked as lead auditor in Qualification / Sponsor study audits including overseas CROs with respect to GCP and GLP compliance.*Faced and successfully managed ISO audits for ISO:9001 and ISO:27001 accreditation.*Have handled and successfully responded Regulatory Queries from various regulatory bodies like DCGI, WHO, EMEA, Health Canada, TGA HPFB, AFSSAPS(ANSM).*Have sound knowledge & experience in Pharmacokinetics (PK) and Clinical Phase trials. Certified Internal Auditor for QMS as per ISO 9001, ISO 27001 and ISO 15189.*Well versed in incidence investigations and Quality risk managements.*Developed number of critical Standard Operating Procedures (SOPs) for Clinical study and Quality Assurance Activities *Excellent soft skills (developed number Excel based-VBA program (macros) to generate the error less Blood collection CRFs, Collection tube & IP labels for BABE studies to speed up the process with zero defect),*Have audited more than 500 Pivotal Clinical studies.*Experience in Validation & Implementation of the software/data base like LIMS, safety database, data migrations & Patient Data base management.*Creative & Learning attitude, Hardworking, Goal oriented and Self-Motivation are my positive points to achieve my short term and long-term goals.