Experience supporting internal audits, customer audits, or regulatory inspections* Working knowledge of cGMP regulations (21 CFR Parts 210/211) and applicable ICH guidelines (Q7, Q9, Q10)* Familiarity with Quality Management Systems (e.g., Master Control, Track Wise, Veeva)* Understanding of Data Integrity principles (ALCOA+) including knowledge of 21 CFR Part 11.* Knowledge and hands on experience with QMS data management software such as Master Control, Track Wise, Veeva, etc.* Ability to display excellent time management skills.* This role supports internal audits, customer audits, and regulatory inspections, contributing to continuous inspection readiness and compliance with global regulatory requirements (e.g., FDA, DEA, and applicable ex-US authorities).The position contributes to audit lifecycle activities, including audit preparation, execution support, CAPA coordination, and effectiveness tracking, and supports Quality Management System (QMS) activities including investigations, complaints, CAPAs, inspections, quality metrics, and continuous improvement initiatives.