Sastri Veluri
Head Quality & Regulatory @Guardian Drug Company
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WORK HISTORY
Head Quality & Regulatory @Guardian Drug Company
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
Andhra University
Master of Science (M.Sc.), Organic Chemistry
Temple University
Master's degree, Quality Assurance and Regualtory Affairs
SKILLS
ABOUT SASTRI VELURI
Dedicated Quality Professional with expertise in laboratory operations, quality systems…
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