Ameya Paul

QC Systems: GLIMS, LabX, eLogs, Electronic Lab Notebook (ELN). Environmental monitoring (grades B to D cleanrooms in Biotech Drug Substance (BDS) manufacturing facility), water for injection (WFI) sampling, Rapid microbial enumeration, bioburden (water, in process and drug product), endotoxin (MCS and KTA), pH, TOC ,conductivity,routine tests second person review (SPR),and AOC (absence of contamination test).

Data trending analysis and quarterly report. QN checklist to support site investigations. Document updates on Veeva.

Lab stock management (5S and restock). GMP environment and GDP tests review.

• Analysis of different types of water samples with the reference of different microorganism such as E.coli, Coliforms, Pseudomonas aeruginosa, faecal coliform , Clostridium perfringens, Enterococcus, Legionella pneumophila.
• Recorded all data and results accurately and responsibly.
• Operated, maintained and calibrated lab equipment, consistently meeting accuracy and schedule targets.
• Prepared reagents and media to fulfill experiment requirements.

• Responsible for extraction of Biomass includes milling of samples, cell preparation, solvent preparation, and extraction of ethanol and water-soluble extractives from different biomass.
• Near-Infra -red spectroscopic analysis for determination of lignocellulosic content of various biomass. I am handling accelerated solvent extractor and have expertise in the calibration of NIR spectrometer

• Responsible of analysis of water and Waste water with special reference to micrbiological organisms .
• Collected samples and stored according to agreed conditions to maintain quality.
• Maintained clean, organised laboratory workspace to comply with hygiene and safety standards.