Ensure compliance with cGMP, GDP, GLP, Data Integrity (ALCOA+), SOPs, and regulatory guidelines. Perform shop floor QA activities, including line clearance, equipment clearance, area clearance, and in-process verification. Review Batch Manufacturing Records (BMR), logbooks, analytical records, and quality documents for completeness and accuracy. Perform or support analysis of raw materials, intermediates, finished products, water, stability, and cleaning validation samples (as applicable). Operate analytical instruments such as HPLC, GC, UV-Visible Spectrophotometer, FTIR, and Karl Fischer Titrator (for QC roles). Participate in investigations related to deviations, OOS, OOT, incidents, market complaints, Change Controls, and CAPA implementation. Support process validation, cleaning validation, analytical method validation, and equipment qualification activities. Maintain laboratory and QA documentation in compliance with Good Documentation Practices (GDP). Coordinate with Production, Warehouse, Engineering, and EHS to resolve quality-related issues. Ensure timely calibration and maintenance of laboratory instruments and monitoring equipment. Participate in internal audits, customer audits, and regulatory inspections (USFDA, MHRA, EU GMP, WHO GMP). Monitor environmental and GMP compliance within manufacturing and laboratory areas. Maintain quality records, registers, and reports for management review.
