职责描述： 1. Prepare an d implement annual department goals an d objectives according to the strategic target set by the company. 根据公司下达的战略目标，制定并实施年度部门目标。 2. Participation in management reviews of process an d product quality an d assist to establish an d improve the quality management system. Improve quality management level by ensuring the timely an d effective communication an d process upgrades. 参与工艺流程、产品质量管理评审，协助建立和完善质量管理体系，确保及时有效的沟通和升级工艺以提高质量管理的水平。 3. Responsible for daily production management prepare an d implement production plans ensure the product changeover is appropriate resources are reasonably allocated an d the production schedule can be tracked to guarantee non-interrupted supply of marketed products. 全面负责日常生产管理工作，制定和实施生产计划，确保通过恰当的产品轮换生产方式，合理配置资源，追踪生产进度保证上市产品的无间断供应。 4. Responsible for management of warehouses ensuring the management of raw materials excipients warehouse semi-finished products warehouse an d finished products warehouse comply with regulatory requirements an d management requirements of company GMP Warehouse Policies. 负责公司各仓库的管理工作，确保原辅料库、中间产品库和成品库的管理符合法规要求和公司GMP库房政策的管理要求。 5. Order manufacturing consumables components an d materials required against the production targets an d product mixes. 根据生产目标和产品组合采购需要的生产耗材、组分和物料。 6. Taking part in deviation handling an d change control. Undertake failure investigations associated with the Manufacturing department 参与生产过程中偏差处理、变更控制。承担生产部门相关的失效调查工作。 7. Draft review an d approve SOPs generated by Manufacturing an d Warehouse. Approve the instructions relating to production operations an d ensure GMP compliance. 起草，审核和批准生产部和仓库生成的SOP。批准与生产操作相关的指示，严格执行各相关SOP，保证GMP合规性。 8. Responsible for reviewing product batch production records ensuring the batch production records are accurate complete an d correct. 负责公司各产品批生产记录的审核工作，确保各产品批生产记录的准确、完整、正确。 9. Ensure proper calibration validation an d maintenance of plant an d equipment in the department 确保本部门厂房和设备得到合理的校准、验证和维护保养。 10. Responsible for the performance management team building talent cultivation recruitment an d training of the Manufacturing department. 负责生产部的绩效管理、团队建设、人才培养、招聘录用、培训等 任职要求： 1.Minimum of 8 years of Pharmaceutical experience establishing implementing refining an d operating manufacturing processes. 至少8年相关制药行业建立、实施、改善和运营生产工艺方面的工作经验。 2.Proven track record managing manufacturing processes. 可靠的生产工艺管理的工作业绩。 3.Knowledge of FDA ISO EMA GMP an d ICH quality systems regulatory. FDA、ISO、EMA、GMP和ICH质量体系、法规方面的知识。 4.Good domain of the English language （speakingwriting）. 良好的英语能力（口语写作）。