Responsible for driving / initiating analysis of Critical test on HPLC and UV instruments
Responsible to manage critical quality issues (Deviations, Incident, OOS Stability failures, etc.) and escalate any issues whenever required.
Responsible for analysis of Critical test on HPLC and UV instruments.
Responsible for calibration of various instruments as per schedule. (I.e. HPLC, Spectrophotometer, dissolution) and troubleshooting on instruments if required.
Responsible to review Site Spec/STP/MOA before proceeding for analysis to ensure availability of resources to proceed analysis activity without any discrepancy.
Responsible for Effective review of Analytical Raw data and Calibration reports.
Preparation and Review of SOP/STP/GTP/GVP/GRP/GIP with Index.
Acts as Single Point of Contact for trouble shooting related to HPLC, peak integration, column response.
Responsible for review of recent site Analytical Method validation report/MOA/Spec-STP and to communicate the identified gaps.
Responsible to ensure the day to day activity being perform in line with GLP and related SOPs.