原辅料分析员

按药典（USP/EP/JP/ChP）及质量标准执行并指导原辅料的检测工作，确保检测方法的科学性与合规性。Perform and guide testing of raw materials/excipients per pharmacopoeias (USP/EP/JP/ChP) and quality standards, ensuring scientific rigor and regulatory compliance of methods.根据检测计划完成样品检测分析，确保结果准确、及时交付。Complete sample testing per schedule to deliver accurate results within timelines.规范填写并审核原始记录，确保符合cGMP及ALCOA+原则，识别潜在数据风险并推动持续改进。Document and review raw data under cGMP/ALCOA+ principles, identifying data risks and driving continuous improvement.主导分析方法的开发、转移、确认及验证工作。Lead development, transfer, qualification, and validation of analytical methods.制定并优化方法学策略，解决复杂技术问题。Develop/optimize methodological strategies to resolve complex technical issues.主导偏差、OOS、变更等的调查与根因分析，制定并推动CAPA措施。Lead investigations (deviations/OOS/change control) and root cause analysis; implement CAPA.起草并参与审核SOP、方法、验证方案及报告等关键技术文件。Draft and review key documents (SOPs, methods, validation protocols/reports).负责实验室运营管理（5S、安全、合规）及团队培养，指导和培训初级研究员。Manage lab operations (5S/safety/compliance) and team development, mentoring junior researchers.推动实验室技术升级及效率优化（如新技术引入、无纸化）。Drive lab technology upgrades (e.g., new techniques, paperless initiatives)完成领导安排的其他工作。Perform other duties assigned by management.