Role & responsibilities
Instrument Calibration: Skilled in calibration and record management of HPLC, GC, UV, Autotitrator, KF, Mastersizer, and other laboratory equipment.
Regulatory Knowledge: Robust 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
📌 Senior Executive Paonta Sahib (India)
🏢 Sentiss Pharma
📍 India
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