Quality Engineer

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Job Title: Quality Engineer-In-process Control

Supervisor’s Title: QE Supervisor

Summary of the Job:

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:

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 NCR handling and non-conformance product to make sure the effectiveness and continuous improvement of in-process.

负责在线的偏差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。

Education and/or experience:

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，Medical device, food or equivalent area.

2年或以上药厂、医疗器械、食品或相关行业在线控制的专业经验。

Qualification:

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 reading and writing.

       良好的英语读写能力。

3．Willing to work shifts

      轮班工作

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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