- 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.