AL

Assistant Manager- QC

Alembic Pharmaceuticals
Vadodara4-8 LPA Posted 9 May 2025
FULL TIME
Hplc
Quality Control
Quality Assurance

Job Description

  • 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 new 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.

Join WhatsApp Channel