本岗位为第三方外包项目岗位，派驻至上海强生制药有限公司
东川路3285号
1、岗位职责
负责OTC产品开发项目的分析方法开发和验证, 撰写分析方法验证方案,报告及分析方法;
Responsible for analytical method development, validation and transfer for OTC NPD projects；technical writing include method validation protocol, report and test method;
· 根据稳定性研究实验方案开展稳定性实验考查,参与OOS/OOT的调查；
Conduct stability testing per stability study protocol, involve in OOS/OOT investigation;
· 负责原料药及辅料和产品质量标准的建立，及供应商资质和产品质量的考察；
sponsible for establishing specifications for API, excipients and finished product, and participate qualifying the vendors and products if necessary;span>· 负责注册申报资料分析研究部分的撰写并为现场检查提供必要的支持；
Responsible for the analytical research data/section of regulatory filing dossier and provide necessary support for on-site inspection;
· 对分析方法从研发中心转移到生产厂提供必要的支持，协助工厂解决技术上难题,以支持新产品和上市产品满足质量和合规的需要;
pan>Provide necessary supports for technical transfers from R&D to manufacturing sites, troubleshoot for analytical issues to support new product and marketed product fully meet the requirement of quality and compliance;参与与相关部门的技术讨论, 与亚洲分析中心，美国研发中心和合同实验室保持紧密的沟通和合作；in the technical discussion with business partners, cooperate closely with AP Technicall Centre, US R&D centers and contract labs;帮助评估及引进新的分析技术,设备以满足新的剂型和产品的开发Help with evaluation and introduction of new analytical technology and instrumentation to support new formulation and product development.
工作评估标准 KPIs (期望达到的水平)
· 新产品分析方法开发及验证的周期
Time needed for method development and validation for new drug product development
· 符合GMP, EHS 和强生公司有关规定的百分比
Percentage of compliance to cGMP, EHS and J&J regulations
· 团队合作的效率
Effectiveness of teamwork
· 注册申报和现场审核时的缺陷率
Percentage of Deficiencies from new drug registrations and regulatory audits
· 开发和上市的产品无分析方面技术问题的百分比
本科或以上学历，药物分析或分析化学相关专业,硕士优先考虑。
Bachelor degree or above, Pharmaceutical Analysis or Analytical Chemistry related, Master preferred