Ketul Khamar
Director Quality Systems & Compliance Global Qa at Revolution Medicines
Based in San Francisco, United States
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Seniority
Other
Department
Other
Location
San Francisco
Industry
Biotechnology Research
Company size
1.3K
Contact information
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k•••••••@revmed.com
Phone
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Background
About Ketul Khamar
Dynamic, Qualified and Passionate Pharmaceutical Quality Lead with over 15 years of experience in all aspects (GMP, GCP, GLP, QSR, GVP) of Global Quality Assurance and Regulatory Compliance. Proven track record of establishing and managing QMS for research, internal manufacturing, and 3rd-party virtual business environments. Expert in shifting company culture, integrating quality into mindsets and promoting positive behaviors.FDA Inspection Readiness & Remediation | Quality Project and Program Leadership Organizational Strategy & Performance Cross-Functional Team Leader QMS Remediations & Continuous Improvements Risk Assessment & Mitigation Policy/SOP/Standards Development Audit Leadership & Regulatory Inspection Management Team Management & Coaching Global ERP Implementation Global QMS ImplementationKPIs & Trend Analysis Change Management Deviations & CAPAs Safety Vigilance Data Analysis & Regulatory Intelligence Product Complaints Training Management Global Product Launches Computer System Validation Good Distribution Practices CMC & Clinical IMP Supply Regulatory Submission Validation & Tech Transfer QBD Principles Stability Program
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