天津招聘

职位要求job requirement:

University graduate in HR, Economics, Management or English major.
大学毕业，人力资源、经济、管理或英语专业。
Over five years HR & Adm. experience in multinational company.
五年以上跨国公司办公室工作经验。
Good organization/coordination ability and teamwork spirit.
良好的组织和协调能力，具有团队合作精神。
Good linguistic proficiency of English and software skills
良好的英语沟通能力及计算机操作技巧。

主要职责main responsibilities:

Manages the activities of several sections in the Quality organization including but not limited to Lab, in process, quality system etc., with responsibility for results in terms of product quality, performance and safety.
对质量部门内各个分支的工作进行管理，以实现产品质量、绩效和安全方面的要求。
Implements the quality systems procedures and manages compliance.
实施质量体系的各种程序，保证合规。
Understands and assures conformance to regulations applicable to the departments. Interfaces with regulators during regulatory inspections.
了解法规对各个部门的要求并保证符合这些要求。在法规检查时负责接待法规部门。
May participate in or manage quality assessments of internal operations and suppliers to analyze compliance and assess risk.
可能参与或管理针对内部运作和供应商的质量评估，从而分析其法规符合性并进行风险评估。
Interacts frequently with internal subordinate supervisors, functional peer and senior group managers
经常保持与下属主管、职能部门的同级管理人员和高级别的经理层的联系沟通。
Manages interactions with regulators and customers to represent the company products and processes.
管理与法规部门和客户间就公司产品和工艺方面所进行的联系沟通。
Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements.
识别和管理以实现质量、可靠性和成本等方面要求为目的的持续改进项目。
Develops budget for several sections or departments and ensures adherence to the budget.
制订部门预算并确保预算控制。
Manages coaching, training and development of subordinates.
管理针对下属的督导、培训和发展。
Ensure that plant management reviews are scheduled, conducted and documented. Reporting on the performance of thequality system to plant management and appropriate Corporate/Divisional/Functional superior representative.
保证按时进行工厂管理评审并书面存档。向工厂管理层和相应的集团/区域/职能管理代表报告质量体系的绩效。
Identify/prioritize/provide resources to assist the Plant Manger to support plant-wide strategy and meet the annual operating plan as well as budgetary commitments.
协助工厂经理确定并提供资源以支持工厂战略发展，从而实现年度运营计划和预算指标。
Manage any projects regarding new products.
管理新产品项目
Detailed QA activities includes but not limited to:
具体的QA职责包括但不仅限于：
Prepare/approve written policies, procedures, specifications, forms and other documents according to the requirements of cGMP, ISO9000, Baxter Quality Standards and local Chinese regulations.
准备/批准根据cGMP，ISO9000，百特质量标准和中国法规要求制定的书面政策、程序、质量标准、表格和其它文件
Monitor the implement of GMP and quality system. Ensure day-to-day operation (Labs, QC and QA/RA) in compliance with policies, SOPs, and procedures, including any department specific requirements. Ensure all the variance, exceptions and changes occurred in the process are reported, evaluated and recorded.
监控GMP和质量体系的实施。确保实验室、质量控制和QA/RA的日常操作符合政策、SOP和部门特定程序的要求。确保所有过程中的出现的不符、偏差和变更均有报告并进行了调查评估和记录。
Review and approve all changes regarding quality.
审核和批准所有与质量有关的变更
Establish the system, review and approve raw materials, WIP, packaging, label and finished products.
建立原辅料、中间产品、包装材料和成品审核和批准体系。
Review and evaluate batch records before product release. Check on finished batch records and lab control records of key processes to make sure that significant discrepancy has been examined and corrective action has been in place.
在产品放行前审核和评估批记录。检查已完成的批记录和关键工序的检验记录以确定重大的偏差和检验结果超标已经过调查且纠正行动已经完成。

Ensure that all required validations and calibrations of monitoring instruments are properly performed.
确保所有必要的验证行为和对监控仪表的校验均已完成。
Review quality performance and audit the QA system regularly. Ensure effective CAPA systems to implement continuous improvement.
定期回顾质量绩效并对QA体系进行审计。确保CAPA系统的有效性以实现持续改进。
Ensure all the employees in the department have gone through the basic and continual training of cGMP and SOPs as per training schedule.
确保部门内所有员工按时完成培训计划所要求的岗前和在岗cGMP和SOP培训。
Monitor production environment and plant hygiene.
监督生产环境和工厂卫生。
Monitor maintenance of facility and utilities, to ensure their operation status is favorable.
监督厂房和设备的维护，以保持其良好的运行状态
Audit, assess and approve the material suppliers.
审计、评估和批准物料供应商。
Confirm storage conditions of products and the retest date or expiry date of material supported by the stability study data.
确认产品的储存条件和根据稳定性研究数据确定的物料的复验期或有效期。
Response and solve the customer complaint, ensure complained issues are investigated and managed in time. Report the ADR according to the Corporate and national requirements.
响应并解决客户投诉，确保所有投诉问题均进过了及时、正确的调查和解决。根据集团及国家要求报告不良反应事件。
Ensure self-inspection of plant quality system is performed as per schedule.
确保按时完成针对工厂质量体系的自检
Ensure the completion of the continuing stability study of products, providing the stability study data properly.
确保完成产品的持续稳定性考察计划，提供稳定性考察的数据
Ensure completion of Product Quality Review
确保完成产品质量回顾分析

百特是全球领先的医疗用品公司，百特专注于危重治疗领域，在肾科、药物输注和生物科技等领域通过提供先进的多样化的产品和服务。
百特总部设在美国芝加哥，是***进入中国医疗市场的大型跨国公司之一，目前已在中国多个城市建立了办事处，并建立了五家大规模的合资和独资生产企业，一家研发中心。
天津百特医疗用品有限公司于1995年成立，占地面积10,496平米，其中实验室2,400平方米，500余名员工。目前主要产品是以葡萄糖、氯化钠为代表的大输液产品。
未来两年内，百特天津工厂将投产肾科相关腹膜透析产品，目前正在进行项目建设中，诚邀各方英才的加入！