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Clinical Quality Assurance

SUMMARY * 20+ years of experience in Quality Management and continuous improvement of quality, within Drug Safety, Clinical, Manufacturing, Regulatory Compliance and R &D domains of Bio-Pharmaceuticals * Conducted risk based Investigator site global audits including contract global central clinical labs * Conducted and Managed CRO's, 3rd party vendors / service providers for GCP and GvP compliance * Supported Internal and e...

Tags for this Online Resume: Services, Compliance, Infrastructure, Link Access Procedure (LAP), Research and Development, SDLC, Test, Packaging, Product Development, Quality