Senior Executive

Role & responsibilities

• Instrument Calibration: Skilled in calibration and record management of HPLC, GC, UV, Autotitrator, KF, Mastersizer, and other laboratory equipment.
• Regulatory Knowledge: Strong understanding of Schedule L, Schedule M, 21 CFR Part 11, EU Annexure 11, Data Integrity, and ICH guidelines.
• Investigations: Experience handling OOC (Out of Control), laboratory incidents, deviations, and preparing SOPs.
• Standards Management: Knowledge of working standard preparation, reference standard management, and procurement.
• Validation: Experience in IQ, OQ, and PQ preparation and execution.
• QC Analyst Qualification: Knowledge of QC analyst qualification processes.
• Software Skills: Familiarity with LIMS (Laboratory Information Management System) and ERP software.

Preferred candidate profile

Injectable/Opthalmic Background