Quality Engineer

Guangzhou - China

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

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 dont 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

Supervisors Title: QE Supervisor

Summary of the Job:

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

监督生产运作符合GMP和SOP的要求.

2Responsible 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

3On-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GMPISO和SOP等)

4Final 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

5Coordinate 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

6Coordinate 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 pharmaceuticalMedical 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

3Willing 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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