Summary Manages Quality aspects and projects within area of responsibility -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems Key Responsibilities As QMS Specialist ensures documents are in compliance with Good Documentation Practice GDP and internal procedures providing a QMS review and QC check prior to final QA approval As CR manager support Development Authors and track Change Requests CRs in 1-DMT ensuring timely progress and release of valuable Quality documents in alignment with stakeholder As SOP Manager for assigned Development Line Function manage stakeholder access and approval workflow in ESOPS Collaborate with global and local teams to resolve document lifecycle issues and ensure training release on time Active participation in Global projects related to QMS e g Global QMS simplification CQMS Optimization and in Global Boards e g GPGV representing RDQ QMS Support governance activities by monitoring CR metrics preparing reports and facilitating cleanup initiatives Provide support for QMS integration for newly acquired companies SPOC for Business Line Functions for Document Lifecycle Management Support audits and inspections related to QMS topics SPOC for the QMS tools Training systems document maintenance Provide technical or administrative support for users Maintain access to DLM and LMS stakeholders Perform validation activities in 1-DMT and feed training BOT Minimum Requirements Bachelor Technical degree in Life Sciences or related fields Advanced degree and or MBA an advantage Excellent English language skills Significant relevant work experience 5 years in the pharmaceutical industry or public health sector in the area of R D Quality or Training Demonstrated knowledge in implementing managing robust Document management systems and Learning Management Systems setting global quality controls in a regulated area Sound understanding of regulated activities health authority expectations and GxP paired wit

📌 Global Quality Management System Rdq Specialist (Hyderabad)
🏢 Novartis
📍 Hyderabad