Quality Control Specialist
CurrentTechnical knowledge: • Involved in end-to-end validation, commissioning and decommissioning of equipment• Trained in UV-Vis, Waters HPLC (Empower), AA, Fluorometer, FTIR for pharmacopeia test methods • Qualified trainer for TOC and HPLCJob Responsibilities: • Executed validation and qualification (IQOQ, PQ) of laboratory equipment such as Fridge, Freezer, TOC Analyzer, HPLC and Post Column Derivatisation. • Supported continuous improvement initiatives throughout lab startup phase till routine testing phase. Brainstormed ideas for implementation to enhance efficiency of day-to-day lab operations. • Authored CSV documents, SOPs, logbooks and risk assessments for the qualification and operation of laboratory instruments.• Performed various Pharmacopeia based testing such as Identification tests, Endotoxins, LOD, Titration Assays, HPLC analysis of raw material, finished goods, stability and validation excipient samples to achieve team KPI.• Performed the role of equipment calibration coordinator and liaised with various internal and external stakeholders to execute timely calibration of 111 equipment with zero overdue. Exercised due diligence to conduct market research sourcing to secure the best competitive price for equipment calibration services to save cost of up to 30%. • Carried out training of testing and equipment usage to QC colleagues.• Ensured laboratory documents follow GDP-compliance to ensure completeness, accuracy, consistency, and clarity based on ALCOA+ Principles, data integrity and GxP requirements.• Maintained the laboratory in a clean, safe and audit ready manner.• Involved in troubleshooting of equipment for investigation, e.g. HPLC, TOC analyzer, Post Column Derivatisation. • Created data spreadsheets with Microsoft Excel for analytical data analysis, schedule planning and performance tracking purposes etc. • Participated in procurement of laboratory and office supplies required.