Job Title

Job Purpose: To support the implementation and maintenance of the Quality Management System (QMS) ensuring compliance with Good Distribution Practice (GDP), Good Manufacturing Practice (GMP), and applicable regulatory requirements. The QA Executive will be responsible for reviewing, monitoring, and supporting quality-related operations both internally and with outsourced service providers. Key Responsibilities: Review and evaluate new and existing customers and suppliers to ensure compliance with GDP guidelines and Novumgen’s licensed scope. Ensure that all GDP and GMP-related activities are fully compliant with regulatory requirements and company licenses. Conduct periodic reviews and updates of departmental Standard Operating Procedures (SOPs), Work Instructions (WIs), and associated forms for accuracy, relevance, and compliance. Provide training to personnel on SOPs, WIs, documentation practices, and requirements under GMP and GDP standards. Review and assess qualification documentation including Quality Questionnaires and Technical Quality Agreements in line with regulatory expectations. Monitor and report on the effectiveness of the Quality Management System (QMS) within the organization and external service providers to ensure compliance and continuous improvement. Review and ensure timely approval and closure of Change Controls, Deviations, Complaints, and other QMS documentation in alignment with applicable procedures and standards. Review and monitor Quality Management System (QMS) dashboard activities to ensure timely tracking and resolution of quality metrics and actions. Ensure Quality Management Reviews (QMRs) and trend analyses are performed as per internal requirements. Carry out tasks assigned by the RP/RPi and management.