工作内容
Key Responsibilities• Ensure adherence to applicable GMP standards and relevant regulatory requirements across all quality assurance activities• Perform review and approval of manufacturing documentation including batch records, production-related documents, SOPs, and quality reports• Lead and coordinate investigations related to quality events, including deviations, CAPA implementation, and change control activities• Track, evaluate, and interpret quality performance indicators to support continuous improvement initiatives• Serve as a technical expert in GMP compliance and provide support during regulatory audits and inspections• Facilitate regular quality governance meetings on a monthly basis at site level• Support capability building of team members and promote a strong quality-focused culture within the organization
