Krishna Veni

Background

About Krishna Veni

Having 12+ years in Quality Assurance in pharma R&D API • Provide proper guidance on quality regulatory & compliance issues to the process development team. • Establish and ensure the Quality management system in CRD and ARD. • Establish and ensure the Laboratory management system in CRD and ARD. • Review the documents received from R&D AR&D etc. so that the same can be shared with authorities and customers. • Review the process change proposals and provide guidance on change proposals. • Prepare in-house expert reports/Quality overall summary (QOS). • Ensure proper stage gate compliance at every stage of product development. • Conduct internal audits properly. • Review the process developmental reports and other process documents (Process Feasibility Process Optimization Lab Validation Technology Transfer) • Review the method developmental reports and other documents (Method Development Method Validation Method Transfer) • Inspect quality till the exhibit batch stage. • Ensure smooth scale-up of the new product. • Carry out proper documentation in labs as well as plants. • Document all the procedures. • Responsible for the overall quality of the organization. • Assure quality by design i.e.ensure robustness of product and process. • Qualify resources and give them approvals. • Product Development life cycle management. • Method Life Cycle Management. • Pharmacopeia Compliance • GxP & Laboratory System for Development Labs.