Deputy Manager - Section Head - Lab QA

Job Description

Relevant Experience: QC exposure of 14 to 16 Years of experience from Regulatory Approved Plant (USFDA/MHRA) of OSD facilities. Exposure Areas: Experienced in handling critical QC instruments such as HPLC, GC, UV, FTIR, KF Autotitrator, Malvern Particle Size Analyzer, and others. Skilled in participating in Quality Management System (QMS) investigations, including OOS/OOT and lab incidents. Proficient in reviewing QC analytical records in electronic LIMS systems, including Labware LIMS, and analyzing audit trail activities of instruments. Possesses strong knowledge of Analytical Method Validation, Analytical Method Transfer, and industry standards such as ICH Guidelines, Quality Risk Management (QRM), Nitrosamine and Elemental Impurity Guidelines, as well as compliance with 21 CFR Part 11, EU Annex 11, and GAMP5 guidelines for computerized system validation.