Venkateswarulu Addanki

WORK HISTORY

EDUCATION

ABOUT VENKATESWARULU ADDANKI

Responsible for production planning, timely execution and supervision of manufacturing activities by following the Environment Health and Safety norms. Make sure all time readiness for all Regulatory (USFDA, WHO, EDQM, KFDA and PMDA etc.) and Safety audits and adherence to compliance. Preparation & Review of 3 month Rolling Production Plan for site & Contract manufacturing in alignment with Market demand flow. Planning suitable equipment’s and reviewing the BPR’s, Quality risk assessment and Safety Risk assessment based on Drug report received from R&D. Identifying capacity limitations and process problems, optimization of process parameters, timings and process stabilization in commercial Scale. Responsible for Production taking care of clean rooms and Intermediates Blocks (A Multi product facility). Responsible for achieve the production targets and dispatch targets by maintaining budgeted consumption norms with targeted yield, quality and Safety. Monitoring yields, monthly CC’s, Raw material Cost (RMC) and highlighting it to management if any discrepancy. Responsible for scale up of Repeater/Launch products from Pilot scale to large commercial scale. Monitoring & Coordination of New Product & Site transfer products with Tech Transfer & Project Management Team for successful project execution Providing training time to time for upgrading the GMP and technical skills to the team to overcome from noncompliance issues and for smooth production run. Maintain and adhere to cGMP, Quality Management System activities, documentation in the plant by implementing and following ICH-Q7 & 21CFR guidelines. Discussion with cross functional team (WH, QA, QC, R&D, PPIC and BD) for daily production activity, RM release & dispatch activity. Preparation and Review of validation protocol, evaluation and investigation of critical and unplanned Deviations. Identifying safety needs during operations and provide training for the persons on awareness of safety precautions as per the MSDS and Improve plant environmental conditions as per EHS regulations. Responsible for Effective Utilization of Manpower and machine runs for enhancing the Productivity. Evaluate proposed changes in product, process or equipment through Change Control. Carry out root cause analysis for the OOS, OOT investigations with proper CAPA. Daily monitoring of Production & Sales plan vs. actual & highlighting issues to the management.