GxP Quality Management Analyst

A company is looking for a QMS Analyst. Key Responsibilities Administer the electronic Quality Document Management System and develop Quality System procedures in line with GxP regulatory requirements Support internal and external quality system audits, including hosting customer audits and tracking audit observations Collaborate with Product Development to assess product changes and ensure compliance with validation requirements Required Qualifications 3+ years of experience in Quality Assurance and managing QMS frameworks in a GxP regulatory environment Experience in conducting GxP audits, preferably hosting them Understanding of Computer Software validation procedures Basic knowledge of GxP regulations such as ICH E6 and 21 CFR part 11 Experience in developing training materials is a plus

Mar 18, 2025 - 19:34

A company is looking for a QMS Analyst. Key Responsibilities Administer the electronic Quality Document Management System and develop Quality System procedures in line with GxP regulatory requirements Support internal and external quality system audits, including hosting customer audits and tracking audit observations Collaborate with Product Development to assess product changes and ensure compliance with validation requirements Required Qualifications 3+ years of experience in Quality Assurance and managing QMS frameworks in a GxP regulatory environment Experience in conducting GxP audits, preferably hosting them Understanding of Computer Software validation procedures Basic knowledge of GxP regulations such as ICH E6 and 21 CFR part 11 Experience in developing training materials is a plus