Description
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- 全面负责产品质量管理工作，独立履行职责，在公司内部对产品质量管理具有裁决权
Fully responsible for product quality management, perform duties independently, make decision for product quality management
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- 组织建立和完善公司经营质量管理体现，对该体系进行监控，确保其有效运行。
Organize the establishment and improvement of the company's business quality management system, monitor the system and ensure its effective operation
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- 通过符合相应要求（法律、法规和强生质量政策、标准和程序的要素等）来建立和维护质量体系。
Establishing and maintaining Quality System via transposition of the applicable requirements (laws, regulations and the elements of the J&J quality policy, standards and procedures etc.).
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- 定期对公司经营质量管理体系进行监督检查，检查结果直接上报所在地食品药品监督部门。
Conduct regular supervision and inspection of the company's business quality management system, and report the inspection results directly to HA
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- 定期在质量管理体系关键要素发生重大变化时，组织开展内审。
Organize internal audits on a regular basis when key elements of the quality management system change significantly
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- 对公司购进、储存、销售、运输过程中涉及的可能影响产品质量等问题行使决定权。
Make decision on the company's purchase, storage, sales, transportation and other issues that may affect product quality.
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- 对公司的购销资质证明文件、产品标签说明书、合同、票据、汇款单位、产品来源及真伪等进行审查和甄别。
Review and identify the purchase and sales qualification documents, product label instructions, contracts, bills, remittance units, product sources and authenticity, etc
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- 审核质量管理程序，组织对各项质量管理程序执行情况的检查与考核。
Audit quality management procedures, conduct inspection and assessment of the implementation of quality management procedures
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- 负责对首营企业和首营品种的质量审批。
Quality approval for first sale enterprise and first sale product
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- 研究和确定公司质量管理工作的重大问题。
Research and identify major issues of quality management。
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- 负责对计算机系统权限的审批。
Approval of computer system permissions
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- 负责验证工作的监督、指导、协调与审批。
Responsible for the supervision, guidance, coordination and approval of validation work
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- 根据质量手册中概述的上报程序，通知LOC商业质量负责人和其他受影响利益相关者有关产品质量、安全性和/或IT合规性的任何实质性问题。
Notify and engage LOC Head of Commercial Quality and other affected stakeholders with any substantive concerns regarding product quality, safety and/or IT compliance, as per the Escalation procedures outlined in Quality Manual.
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- 根据统计数据分析，向经理和其他利益相关者提供质量洞察力。
Provide quality insight to manager and other stakeholders according to statistics data analysis.
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- 领导并上报关键产品问题，并及时支持召回/现场行动。
Lead and escalate critical product issue and support the recall/field actions in timely manner.
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- 质量负责人指定的其他工作。
Other works assign by Head of Quality.
Qualifications
- 良好的英语写作和口语能力
Good command in English both in writing and verbally
- 需要战略思考，同时重点是过程改进和优化。
Strategic thinking is required, with a focus on process improvement and optimization.
- 具有较强的项目管理能力，能够管理多项任务。
Demonstrates strong project management skills, with the ability to manage the multiple tasks.
- Microsoft软件和演示的专业知识。
Expert knowledge of Microsoft software and presentation.