Rajasekhar V V
CQA, Aurobindo Pharma
Medicine
Aurobindo
India
Biography
Corporate Quality Company Name Aurobindo Pharma Dates Employed Jul 2011 – Present Employment Duration 6 yrs 3 mos Location Hyderabad Area, India Over viewing of critical product complaints, received from US, Europe and ROW customers across all the formulation units. Reviewing the critical event investigations, assess the impact of the event investigations and need for overall CAPA’s in view of harmonizing the quality systems across all the formulation sites. Identifying the need for notifications and market actions (like Field Alert Reporting, Field Corrections, Recall etc) and coordinating with respective regulatory with the help of authorized agents or qualified persons. Preparation and review of harmonized procedures of Quality systems. Interpretation of critical process deviations and review of failure investigations. Training the plant staff on effective implementation of common procedures and on investigation techniques to have an effective investigation procedure across all the formulation units.
Research Interest
Pharmaceutical Science