Rajesh Patidar

Experience

1. Project Lead

   Msgmp Gxpro Pharma Project Consultant

   Dec 2022 — Present · Indore, IN

   Consulting for Sterile Formulation (Injectable), Sterile API, Orals Formulation, API, Microbiology, In vitro Diagnostic (IVD) Regulatory Audit Preparations-USFDA, MHRA, EU-GMP, WHO- Geneva etc. Compliance Assessment, Audit Preparation, Documentation Review, Audit Planning, Audit Execution, Compliance Gap Identification, Reporting and Communication, Corrective Action and Follow-up, Regulatory Liaison Laboratory Inspections Along with Documentation Audits of Laboratory & Writing Reports That Included Any Deficiencies/Deviations Conducting Investigation, Audit, Root Cause Analysis, Potential Solutions, and Corrective Actions in line with International Regulatory Authorities like USFDA, EU GMP, PICSs, ANVISA etc. Validation/Qualification of the Facility /Equipment(s)/ System(s)/ Process Simulation/Process Validation/Cleaning Validation/Hold Time and Qualification activities Preparation & Review of The Validation/Qualification Documents i.e, Protocol, Report, Executive Summary, SOP’s and Guidance Documents (VMP/Policies) Remediation Projects in Handling /Harmonization/Implementation/Improvement of Quality Systems: OOS/OOT, Deviation / Incidence, Change Control, CAPA, Risk Analysis, Impact Assessment, Gap Analysis and Failure Investigation Procedures Writing and Implementation of Global Policy and Global Procedures in Compliance to ICH Guidelines, USFDA 21 CFRs, EU GMP and WHO etc. ANDA and other Dossiers Related Data Review & Support in Response Preparations & Compliance for Various Audits of USFDA, EUGMP & Other International Regulatory Audits Licensing In/Out