Hire Sujit Wazarkar, a pharma consultant specializing in FDA Inspections, Pharmaceutical Manufacturing and Pharmaceutical Quality. See services offered, experience summary, and connect via apicule.
Based in: India
Willing to work in: Global
Consultant Type: Independent Consultant
Expertise summary: Sujit Wazarkar is a pharmaceutical and medical device quality professional specializing in computerized system validation and IT quality assurance. His expertise includes GMP compliance, FDA inspection readiness, change management, deviation investigations, supplier qualification, and qualification of computerized manufacturing systems. He has managed validation activities across GxP systems, cloud applications, PLC and SCADA controls, and Excel spreadsheets. His background also covers data migration, electronic records, digital validation tools, and system retirement. He helps organizations strengthen validation documentation, assess system changes, maintain data integrity, and prepare computerized system records for regulatory inspections. - Show More
Sujit supports change management for GxP computerized systems through risk and impact assessments, validation planning, and review of change records. His experience covers cloud releases, software upgrades, hardware changes, and system migrations. He helps teams define appropriate testing, update validation documentation, and coordinate change evaluation, approval, and closure.
Sujit supports deviation and incident management within computerized system validation and IT quality operations. His experience includes deviation investigations, defect tracking, and review of incidents affecting validated systems. He helps teams document findings, assess their impact on validation activities, and maintain supporting records for issue resolution and quality review.
Sujit supports qualification of computerized controls associated with pharmaceutical manufacturing equipment. His experience includes PLC and SCADA system validation and preparation, review, and approval of IQ, OQ, and PQ documentation. He helps teams verify control-system requirements, document test results, and assess requalification needs following hardware or software changes.
Sujit supports FDA inspection readiness for computerized systems and IT quality documentation. He has prepared audit packages, identified documentation gaps, and served as a QA-CSV subject matter expert during supplier and regulatory inspections. His experience includes supporting US FDA, BSI, and MDSAP assessments and presenting validation records to auditors.
Sujit supports GMP compliance for computerized systems through validation, data integrity controls, and good documentation practices. His experience includes applying 21 CFR Part 11, EU Annex 11, and GAMP 5 principles to GxP systems. He helps teams review electronic records, document testing, and manage data migration and archival activities within controlled processes.
Sujit supports IT quality assurance for pharmaceutical and medical device organizations through computerized system validation oversight. His experience includes reviewing validation plans, user requirements, risk assessments, test protocols, and summary reports. He helps teams maintain traceable documentation and coordinate quality reviews throughout system implementation, operation, periodic review, and retirement.
Sujit supports supplier qualification and oversight for GxP software, cloud services, and computerized systems. His background includes vendor assessments, supplier coordination, service-level and quality agreement oversight, and supplier performance monitoring. He helps organizations review supplier responsibilities and coordinate validation requirements for externally provided systems and services.
