上海招聘

岗位职责：
1． Project phase 项目阶段

? Final reviewing validation protocols, reports, maintenance and calibration of critical equipment and facilities. 最终审查验证方案，验证报告，关键设备和设施的维护和校准。

? Review and approve documents which relevant to quality management systems. 根据相关的质量管理体系审查和批准文件。

? Organize the supplier audit. 组织供应商的审核。

? Carry out the GMP training program for whole company or QA staffs. 推进整个公司或QA人员的GMP培训项目。

2．Operation phase 运营阶段

? Maintain and continuously improve the quality management systems. 保持并持续改进的质量管理体系。

? Finally review completed batch production and laboratory control records of critical process steps before releasing or rejecting all APIs. 在放行或拒绝所有的API之前，最终审查完成批量生产和实验室控制记录关键工艺步骤。

? Releasing or rejecting intermediates for use outside the control of the manufacturing company. 放行或拒绝中间体，使用于制造公司的控制范围之外。

? Maintain a good system to release or reject raw materials, intermediates, packaging and labeling materials. 保持一个良好的制度，放行或拒收原料，中间体，包装和标签材料。

? Making sure that critical deviations, OOS, OOT are investigated and resolved. 确保关键的偏差，OOS，OOT调查及解决。

? Finally review all specifications and master production instructions. 最后审查所有规格和主生产指令。

? Finally review all procedures impacting the quality of intermediates or APIs. 最后审查所有程序，影响中间体或原料药的质量。

? Organize and make sure that internal audits (self-inspections) are performed and all the CAPA are closed. 组织并确保进行内部审计（自查），并关闭所有的CAPA。

? Final reviewing intermediate and API contract manufacturers. 最终审查中间体和原料药的合同制造商。

? Final reviewing changes that potentially impact intermediate or API quality. 最终审查可能影响中间体或原料药质量的变化。

? Final reviewing validation protocols, reports, maintenance and calibration of critical equipment and facilities. 最终审查验证方案，验证报告，关键设备和设施的维护和校准。

? Final reviewing quality related complaints are investigated and resolved. 最终评审质量相关的投诉进行调查和解决。

? Checking all materials are appropriately tested and the results are reported. 检查所有的材料适当地测试，报告结果。

? Ensuring there is stability data to support retest or expiry dates and storage conditions on APIs and/or intermediates where appropriate. 确保有稳定性数据支持原料药和/或中间体在适当的情况下的复验期或有效期和储存条件。

? Organize the product quality reviews. 组织产品质量检验。

? Review and approve documents which relevant to quality management systems. 根据相关的质量管理体系审查和批准文件。

? Organize the supplier audit. 组织供应商的审核。

? Carry out the GMP training program for whole company or QA staffs. 推进整个公司或QA人员的GMP培训项目。 Critical Experience and Skills/关键技能和经验

? Pharmaceutical or chemical degree or similar back ground (bachelor or above) 药物或化学或类似学历背景（本科或以上）

? More than 5 years’ experience in API quality management related job (with the experience in API workshop management or foreign company’s experience is priority) 5年以上API质量管理有关的工作经验（原料药车间管理经验或外资公司经验优先）。

? Have the experience of participation the GMP inspection from FDA, EDQM, SFDA or other stringent regions. 有参与FDA，EDQM，国家食品药品监督管理局或其他严格地区的GMP检查经验。

? Experience of working in an international team. 有国际化团队的工作经验。

? Good oral and written English skill 良好的英语说和写的能力。

任职资格的具体描述：
? Strong team player 良好的团队合作精神。

? Self-motivator with ability to work independently 自主工作与独立工作的能力。

? Creative and solution orientated approach to issues resolution. 具备创新和结果导向的解决问题的能力。

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