职责/Responsibilities l 监测并确保 QC 实验室内符合质量保证标准，确保所有活动符合药品生产质量管理规范 (GMP) 和适用法规。 Monitor and ensure compliance with quality assurance standards within the QC lab, ensuring that all activities comply with Good Manufacturing Practices (GMP) and applicable regulations. l 审核并批准实验室检测结果、分析程序和其他相关文件，以确保所有文件完整、准确且符合行业法规（FDA、欧洲药品管理局、ISO等）。 Review and approve lab test results, analytical procedures, and other relevant documentation to ensure all are complete, accurate, and compliant with industry regulations (FDA, EMA, ISO, etc.). l 准备并支持内部和外部审计和监管检查，确保完全遵守适用的监管要求和公司政策。 Prepare for and support internal and external audits and regulatory inspections, ensuring full adherence to applicable regulatory requirements and company policies. l 主动识别检测过程和实验室操作中的潜在风险，并领导调查和纠正/预防措施 (CAPA) 以缓解问题，确保始终符合合规性和质量标准。 Proactively identify potential risks in testing processes and laboratory operations, and lead investigations and corrective/preventive actions (CAPA) to mitigate issues, ensuring compliance and quality standards are consistently met. l 监督并确保实验室检测方法的适当验证，包括生物学、微生物学和受体检测，符合法规要求和行业最佳实践。 Oversee and ensure proper validation of laboratory test methods, including biologic, microbiology, and recipient testing in alignment with regulatory requirements and industry best practices. l 与其他部门（包括QA、生产和监管团队）密切合作，以解决质量相关问题，并确保整个实验室和更广泛业务部门的的顺利运行。 Work closely with other departments, including QA, production, and regulatory teams, to resolve quality-related issues and ensure smooth operations across the lab and wider business functions. 资质要求/Qualifications: l 化学、生物化学、生物学、药学本科及本科以上学历。 Bachelor degree or above in Chemistry, Biochemistry, Biology, Pharmaceutical. l 在GMP监管要求的制药实验室中，至少有3年的质量保证或质量控制经验。 Minimum 3 years of experience in a Quality Assurance or Quality Control role within a GMP-regulated pharmaceutical laboratory. l 在制药或生物技术行业中，对于生物、微生物或化学检测方面拥有丰富的经验。 Solid experience in biological ，microbiological or chemical testing within the pharmaceutical or biotechnology industry. l 卓越的沟通能力（口头和书面），能够与不同的利益相关者合作互动。 Excellent communication skills, both verbal and written, with the ability to interact with various stakeholders. l 精通使用质量管理软件、LIMS和其他实验室系统进行记录和跟踪。 Proficient in using quality management software, LIMS, and other lab systems for documentation and tracking.