Alex Quitazol
Sr Gcp Pv Auditor (Global Gxp Expert Auditor), Global Quality Audit & Compliance @诺华
Burlington, ON, CA
EMAILS
MOBILE NUMBERS
+91 *********19
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WORK HISTORY
Mar 2017 — Present
Sr Gcp Pv Auditor (Global Gxp Expert Auditor), Global Quality Audit & Compliance @诺华
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EDUCATION
2001
SoCRA (Society of Clinical Research Associates)
CCRP - Certified Clinical Research Professional
1990 — 1994
Velez College (Cebu Institute of Medicine)
BSMT, Medical Technology
2008
ASQ - American Society for Quality
CQA - Certified Quality Auditor
SKILLS
CRO ManagementProtocolComputer System ValidationU.s. Food and Drug Administration (Fda)Regulatory RequirementsValidationClinical DevelopmentGcpRegulatory SubmissionsClinical Data ManagementClinical ResearchCapaEdcCtmsSop DevelopmentIch-GcpV&VClinical Trial Management System (Ctms)U.s. Title 21 Cfr Part 11 RegulationGood Clinical Practice (Gcp)Regulatory AffairsClinical TrialsPharmaceutical IndustrySopFdaQuality Assurance21 Cfr Part 11CROGlpGmpStandard Operating Procedure (Sop)GxpQuality Auditing
ABOUT ALEX QUITAZOL
Specialties: Clinical Quality Assurance; Clinical Investigator Site Audits; Vendor Audits; System and Process Audits; Computer System Validation and Audits; GCP Training; 21 CFR 11 and Computer System Validation Training
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