天津招聘

质量工程师 关于百特

百特提供多样化的核心肾脏和医院产品线，包括家庭治疗、急重症和中心透析治疗;无菌静脉解决方案;注入系统和设备;肠外营养;手术产品和麻醉学手术;自动化药房，软件和服务。百特在全球的足迹和对产品和服务的关键作用在扩大新兴和发达国家的医疗保健方面发挥了关键作用。百特全球员工基于公司丰富的医学突破的传统上正在促进下一代的员工创新医疗让病人得到照顾。

你将会做的是 很难列出你在百特要做的每件事因为每天都不同，但有些事很清楚是你要做的：

This section focuses on the main purpose of the job.

职位的主要目的。

1. Supervise operations to comply with requirements of GMP & ISO.

监督生产运作符合GMP和SOP的要求.。

2. Responsible for endorsing process and product quality, efficacy. And safety through the routine assessment of plant operations and finished products. Responsible for ensuring adherence to the regulatory and procedural requirements that govern those operations and products.

负责过程和产品的质量、功效,通过日常的审核评估活动,保证过程的安全性;确保生产操作和产品符合法规和规程的要求。

3. On-line GMP, ISO and SOP audit to make sure the production process comply with the requirement.

负责生产区域的质量保证审核(包括GMP、ISO和SOP等)。

4. Final product AQL inspection to make sure the finish goods’ quality compliance.

最终成品的AQL检查以保证成品质量符合规定。

5. Coordinate the exception in process to assure a effective quality system.

协调生产过程中的异常情况以确保质量体系的有效性。

6. Coordinate the change/validation and online improvement.

协调生产过程中的变更/验证以及生产线的改进。

Essential Duties and Responsibilities:基本义务和职责

This section contains a list of six primary responsible roles. The incumbent will perform other duties assigned.

该部分包含了 6 个主要的责任角色，任职者还须承担一些其它指定的工作。

1. Supervise operations to comply with requirements of GMP & ISO.

监督生产运作符合GMP和SOP的要求。

2. Set up limit sample and validated product criteria (include sample plan & sample size).

制定在线产品缺陷标准和验证过程的产品接受标准(包括取样计划和取样量) 。

3. Monitor the control of in-process and validation process to make sure the effectiveness.

监督生产过程的监控和验证的过程以确保其有效性。

4. Responsible for the control of exception handling and nonconformance product to make sure the effectiveness and continuous improvement of in-process.

负责在线的异常处理和不合格品的控制,确保其有效性和持续改善。

5. Responsible for training & qualification management of on-line inspector.

负责在线检查员培训和资格管理。

6. Ensure and work in compliance with all EHS aspects.

确保工作符合环保、健康和安全的方针政策

您是否具备在百特任职的资质?

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

该职位要取得成功，个人应能令人满意地完成各项基本义务。具备所列的知识、技能及要求具备的能力。对能力稍逊者可以适当调整，要求能完成

基本的职责。

1. Able to work and communicate well with other departments' personnel.

具有团队精神和良好的沟通能力。

2. Good command of English speaking and writing.

良好的英语能力。

Education and/or experience:教育或经验

Include the education and experience that is necessary to perform the job satisfactorily

为能令人满意地完成工作，应具备的教育与经验

1. Bachelor degree or above in pharmaceutical, engineering, science (macromolecule & material preferred) or related field.

药学、工程学、理科(高分子和材料优先)或相关学科的学士或以上学位。

2. 2 years or above on in-process control professional experience at pharmaceutical, food or equivalent area.

2 年或以上药厂、食品或相关行业在线控制的专业经验。

为何选择百特？

这是一项重要的事业

百特员工以拯救生命，延续生命为使命。我们充满激情，运用科技创新满足全球数以百万计人们的需求，他们依赖于百特医疗设备，技术和医疗必需品延续生命。我们致力于让越来越多的人接触到医疗保健，在重要的未知领域开拓创新，追求创新性的合作，以此来实现我们的使命以及对患者的承诺。

立即申请职位，体验这一充满使命的职业！

在百特每个员工享有均等的机会。员工不会因为种族，肤色，宗教，性别，性取向，国籍任何招聘决策，特有地位保护，残疾或其他受到法律保护的因素受到歧视。百特是一个机会均等的雇主，不会因为种族、肤色、宗教、性别、性取向、性别、国籍、受保护的退伍军人地位、残疾或任何其他受法律保护的情况影响招聘决定。

百特国际有限公司提供肾科与医院关键产品的广泛组合，包括居家透析、急重症透析和中心透析产品；无菌静脉输液；输注系统与设备；肠外营养；生物外科产品与麻醉；以及药房自动化、软件和服务。公司凭借全球布局，以及其产品与服务的必需性，在提升新兴与发达国家市场医疗可及性方面发挥至关重要的作用。百特在全球的五万名员工，秉承公司在医疗创新领域的深厚积淀，持续推动未来的医疗创新，更好地满足患者的医疗需求。

Baxter International Inc. provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; biosurgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s 50,000 employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.