Quality Control Analyst

Job description

QC Analyst Roles & Responsibilities: • Perform analysis of raw materials, packing materials, in-process samples, finished products, and stability samples as per approved specifications and test methods. • Operate and maintain analytical instruments such as HPLC, GC, UV-Visible Spectrophotometer, FTIR, Dissolution Apparatus, and other laboratory equipment. • Prepare, standardize, and maintain laboratory reagents, volumetric solutions, and reference standards. • Review analytical data, maintain laboratory records, and ensure compliance with GDP, GLP, and data integrity requirements. • Investigate OOS, OOT, laboratory incidents, and deviations as per approved procedures. • Participate in method verification, method transfer, and analytical method validation activities. • Ensure timely completion of sample analysis and reporting. • Support regulatory audits, customer audits, and internal audits. • Follow cGMP, safety, and quality systems requirements. Microbiologist - Roles & Responsibilities: • Perform microbiological testing of raw materials, finished products, purified water, and environmental monitoring samples. • Conduct environmental monitoring of manufacturing areas, including viable and non-viable monitoring. • Perform microbial limit tests, sterility testing, endotoxin testing, and growth promotion tests. • Prepare and manage microbiological culture media and microbial cultures. • Carry out water system monitoring and trend analysis. • Maintain microbiology laboratory records in compliance with GDP, GLP, cGMP, and data integrity requirements. • Investigate OOS, OOT, deviations, and microbiological excursions. • Participate in method validation, method suitability studies, and qualification activities. • Ensure laboratory housekeeping, equipment calibration, and compliance with safety requirements. • Support internal, regulatory, and customer audits. Qualification B.Sc./M.Sc. (Chemistry/Analytical Chemistry/Microbiology/Biotechnology) or equivalent qualification. Experience 2-4 Years of relevant experience in a pharmaceutical formulation/API manufacturing company. Skills Required • Knowledge of cGMP, GLP, GDP, and Data Integrity. • Hands-on experience with analytical instruments (for QC Analyst) and microbiological testing techniques (for Microbiologist). • Good documentation and investigation skills. • Exposure to regulatory requirements of USFDA, MHRA, EU GMP, WHO GMP, etc.