Sastri Veluri

Head Quality & Regulatory @Guardian Drug Company

Monmouth Junction, NJ, US
EMAILS
s••••••@guardiandrug.com
MOBILE NUMBERS
+17•••••••90

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WORK HISTORY

Mar 2017 — Present

Head Quality & Regulatory @Guardian Drug Company

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Align department objectives and goals with Organization goals. Quality systems (QMS) implementation, and Quality unit qualification to support facility expansion project and new product filings. Quality matrix review, risk assessment and communication to president. Effective utilization of quality resources, training and mentoring quality personnel. Quality operations compliance monitoring with GMP, GLP, FDA regulations. Identify new products for development, oversee Confidentiality and Quality agreements and vendors qualification. Continuous improvement and corrective and preventative actions implementation monitoring. Equipment, test methods and operations validation monitoring and lifecycle management. Leadership and customer/regulatory audits support, follow-up activities. monitoring Manage CMO activities and technology transfer of 8-12 projects. OOS, OOT and complaints investigation strategy and approval.

EDUCATION

N/A

Andhra University

Master of Science (M.Sc.), Organic Chemistry

N/A

Temple University

Master's degree, Quality Assurance and Regualtory Affairs

SKILLS

Pharmaceutical IndustryGlpRegulatory AffairsCgmpAbbreviated New Drug Application (Anda)Generic ProgrammingAnalytical TechniquesStandard Operating Procedure (Sop)Technology TransferHplcGmpV&VPharmaceuticsIndValidationSopQuality by DesignDissolutionQuality ControlRegulatory SubmissionsCleaning ValidationFdaGenericsAnalytical ChemistryMethods DevelopmentU.s. Food and Drug Administration (Fda)AndaTestingCorrective and Preventive Action (Capa)Method DevelopmentMethods ValidationHigh-Performance Liquid Chromatography (Hplc)CapaGood Laboratory Practice (Glp)Analytical Instruments QualificationChange ControlUvSoftware ValidationGxpFormulation

ABOUT SASTRI VELURI

Dedicated Quality Professional with expertise in laboratory operations, quality systems…

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