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Supriya Demagu (CSSGB, CBA)

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CONTACT: [email protected] SUMMARY: Currently working as a RA/QA Manager with Bio-Rad. Masters with 10+ years of experience managing cross-functional projects and programs with tight deadlines in Quality and Regulatory Affairs Supervisory/managerial experience Certified Lead Auditor with 10 years of auditing experience. Lead Internal & Vendor/Supplier Audits Subject Matter Expert in leading and hosting FDA inspections and Audits by Notified Bodies. Possess both Front Room and Back Room Audit Experience. Ability to write clear, understandable technical documents for regulatory submissions. Possesses a keen understanding of Life Cycle Management of Medical Device and Pharmaceutical products along with the impact of such changes on global product registrations. EXPERIENCE: 21 CFR 820 (Quality System Regulations) ISO 13485 (Quality Management Systems) ISO 14971 (Risk Management) IEC 62304 ISO 9001 Skills Set: Design Control, Complaint handling, CAPA (Corrective and Preventive Action), NCMR's (Non-conformance reports), Product recalls, Class II Medical Device Experience, Root Cause Analysis, Incoming Inspection, Lead Auditor Experience, Six Sigma, Software Validation and Verification, Design History File Documentation, Supplier Qualification, Quality Metrics, Verification & Validation (V&V), Process Improvements, Change Control, Training, Technical File, CE Mark, Supplier Quality, GxP, Deviation Management

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