Senior Executive, Lab QA

Responsible for the review and approval of analytical data, method set records, Certificates of Analysis (COAs), laboratory documents, validation/verification/transfer reports, stability documentation, instrument qualification and calibration records, audit trails, investigations, and quality system records. Ensures compliance with cGMP, GLP, data integrity (ALCOA+) principles, regulatory requirements, and internal quality standards through comprehensive review of laboratory activities, documentation, electronic records, and analytical methods.