职位描述:



Responsibilities:1.Work closely with Production Supervision and Engineering to ensure adequacy and appropriateness of inspection parameters, product specifications and test methods. 与生产/工程部门紧密合作，确保检验的参数、产品标准及测试方法的充分性和恰当性。2.Perform routine audit for manufacturing process based on the GMP, ISO and SOPs etc. 对制造区域按GMP、ISO和SOP进行例行的审核。3.Monitor product quality through the performance of required finish products AQL inspection and functional testing. Maintain a working knowledge of statistically based Sampling Plans and their applications. 通过成品的AQL检查及产品的功能性测试进行产品质量监控，通过取样计划及其实施不断提高统计学方面的知识。4.Supervise QC team to perform in-process quality inspection and line clearance effectively. 带领QC团队有效执行在线质量检查和清场。5.Responsible for the label control. Responsible for the confirmation and incoming inspection of new Hot Stamp Die. 负责标签控制。负责新的热压印模的确认及入库检查。6.Make and Implement the defect manual. 制定并履行缺陷产品手册。7.Assist to update the related documents. 协助更新相关文件8.Assist to design and validation of package materials 协助进行包装材料的设计和验证。9. Responsible for approval the SOPs and evaluate all the Tier I CAPA during manufacture process负责批准生产规程和对生产过程的一级CAPA进行评估10. Being familiar and monitoring with monthly quality performance data and recommending any corrective action required and reporting any significant variations or trends.熟练运用质量统计工具监控关键质量指标，对显著的差异提出改进建议并采取纠正行动。11.Submitting monthly daily quality summary, trend analysis, and written monthly report for the Senior Quality Engineer..向高级质量工程师提供月度总结及趋势分析报告12. Communicate with internal plant for the improvement of IPSO products. 和内部供应商合作共同提高IPSO产品的质量。13. Assist customer complaint sample test in time.协助客户投诉样品测试及时完成。14. Coordinate the evaluation for all the material, product, process, and equipment change, ensure all the new (or changed) instruments and equipment have been vilified.协调对物料、产品、工艺和设备的变更作出评估，确保新的(或经改造的)生产设施和设备通过确认。15. This position will responsible for to quality control at production area and warehouse; product, process and equipment’s improvement and quality training for operators负责生产过程的质量控制，对员工就产品、工艺设备的改进进行培训16. Support to prepare and maintain budget for In-process Quality Control section 协助准备并实施有关在线质量控制的预算。17. Motivate, train and counsel subordinates.激励、培训并指导下属的工作。18. Commit to EHS regulatory compliance for the operation of the department and promote the importance of EHS requirements for the effective and efficient operation of the department. 在部门工作中遵守环保，健康和安全的法规要求，并促进环保，健康和安全要求在部门工作中的重要性。

Qualification:1. Working knowledge of statistics and production processes. 具备统计学和生产的工作经验。2. Strong communication skills强的沟通能力。3. Excellent written and verbal communication 良好的书面和口头沟通技巧，技巧。4. Sound judgment and analytical skills to enable assessment of risk and problem solving skills.合理判断，分析和解决问题的技巧。5. Excellent interpersonal skills.良好的人与人之间相处的技巧。6. Resourceful, self-reliant, self-motivated and confident.知识丰富，自信，自励。7. Able to work independently and be flexible to changing priorities.能独立工作，灵活变动优先权。8. Must have excellent teamwork and organizational skills.良好的团队精神和组织技巧。9. Bachelor degree or above, Fluent English both written and spoken, computer skill is required.大学本科或以上学历，英语口语和书写流利，计算机熟练。10. At least 3 year in-process quality control & Quality Assurance experience in the pharmaceutical or related industry.至少具有3年在药品或相关企业在线质量控制和保证的工作经验。11. Strong analytical and problem-solving skills. Have a positive attitude towards qualitymanagement.较强的分析和处理问题的能力，以积极的态度参与质量监控工作。