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Rajesh Kumar
Looking for a jobProject Manager
Project Manager at PQE Group leading CSV and CQV compliance for GxP systems and training readiness.
IndiaProject Manager at PQE Group
Experience
Project Manager
Lead Quality Compliance, Training Readiness, Audit Preparation, and Validation activities for GxP computerized systems. Ensure training completion and effectiveness for QA/QC personnel through LMS tracking and role-based curricula.
CSVCQVGxP21 CFR Part 11Annex 11 RegulationsGAMP 5 Best PracticesLMSSOPsCAPADeviation ManagementChange ControlInternal AuditRegulatory InspectionsQuality OversightTraining OversightRisk Management
Senior Manager – Operations Excellence
Owned training compliance framework, including Department Training Plan Matrix, SOP training, and effectiveness checks. Led internal audits, managed CAPA lifecycle, and ensured alignment of validation activities with GxP regulations.
Training and ComplianceGovernance SOPsInternal AuditCAPARisk AssessmentDeviation ManagementChange ControlValidationGxPCQMSDocumentumLMS
Project Manager – CSV & CQV Compliance
Managed CSV and CQV compliance projects, including establishment of new Microbiology Laboratory with regulatory compliance. Supported training delivery, audit readiness, and QA review of deviations and CAPAs.
CSVCQVMicrobiologyEquipment QualificationURSData QualityIQ+SOPsTrainingAudit ReadinessData IntegrityCAPADeviation Management
Assistant Manager – Microbiology
Acted as Laboratory QA Lead for microbiology, supporting cGMP, GLP, and data integrity compliance. Reviewed and approved deviations, OOS, investigations, CAPA, and change controls.
MicrobiologyGMPGLPData IntegrityCAPADeviation ManagementOOSOOTChange ControlTrainingEquipment QualificationCSVAudit Trail ReviewOPEX CAPEX Budgeting
Senior Executive – Microbiology
Performed QA review of analytical data, SOPs, calibration records, and validation documents. Conducted training on laboratory procedures, GLP, and aseptic techniques.
MicrobiologyQA ReviewSOPsGLPAseptic TechniqueTrainingDocumentumCAPAInternal AuditRegulatory Inspections
Section In-Charge – Microbiology
Worked as Lab in Charge-Microbiology, conducting microbiology studies as per plan and schedule. Handled investigations, OOS, OOT, deviations, and supervised laboratory compliance and CAPA implementation.
MicrobiologyOOSOOTDeviation ManagementCAPASOP Managementtraining coordinationEquipment QualificationValidation Protocols
Junior Manager – Microbiology & IPQA
Managed EM programs, water systems, laboratory investigations, and QA documentation. Conducted risk assessments, SOP reviews, and supported multiple regulatory inspections and internal audits.
MicrobiologyEnvironmental MonitoringWater SystemsQA DocumentationRisk AssessmentSOPsRegulatory InspectionsInternal AuditLaboratory Setup
Education
MSc
MSc in Microbiology.
MBA
MBA in Total Quality Management.
BSc
BSc in Science.