U1- QC- Associate Director
Core
Ensuring Good Laboratory Practices (GLP) compliance, managing QC instrumentation (ICP-MS, HPLC, GC), and overseeing quality control operations for pharmaceutical testing.
Role type
Associate Director, Quality Control (QC)
Builds
Qualified testing results, validated methods, and compliant pharmaceutical products
Domain
Pharmaceutical / Quality Control
Required skills
GLP compliance, LIMS software operation, instrument qualification and calibration, CAPA management, regulatory update tracking, COA review, resource planning
Preferred skills
Method development and validation, elemental impurity study expertise, team planning and delegation
Technologies
LIMS, ICP-MS, HPLC, GC
Responsibilities
Ensure GLP compliance in the lab; Manage availability of reference standards and chemicals; Operate and maintain LIMS software; Ensure instrument qualification and calibration; Create instrument methods for ICP-MS; Prepare and review specifications, SOPs, and protocols; Ensure analyst qualification for testing parameters; Update specifications per pharmacopoeia changes; Investigate OOT/OOS/OOC, deviations, and complaints; Review and approve raw material and API COAs; Approve/reject raw materials and intermediates; Review retest dates for RM/Intermediates/APIs; Evaluate new pharmacopeia monographs; Review and approve validation documents and PQRs; Coordinate with engineers for PM schedules and instrument breakdowns; Plan daily tasks for subordinates; Identify resource requirements and prepare URS for new instruments
