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QA Manager

Req # JR - 028173 Location Shanghai, Shanghai Municipality Job Category Quality Control Date posted 01/20/2021

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Summary:岗位概述:

Assure Baxter Shanghai Plant’s production activities compliant with local health authority & Baxter Corporate quality requirement, the products meet the specification, and Plant achieves the quality KPI. Quality system makes continuous improvement. Manage and develop QA team in supporting product manufacturing and distribution efforts.

Responsibilities:主要职责:

- Ensure quality management system (QMS) meets the requirement of China and EU GMP regulatory & Corporate Quality Manual (CQM), and make continuous improvement.  

- Ensure production activities with the compliance and the high quality, and the process control system makes continuous improvement.

- Ensure that finished product meet the registration requirements and Baxter quality standard. Ensure all necessary tests to be completed, and all deviation and OOL have been investigated and disposed. 

- Review and approve quality related SOP and document. Ensure all the documents are maintained based on Baxter requirement. 

- Ensure all employee related to product quality have passed necessary training. 

- Ensure that all supplier of raw materials and quality related service meet Baxter’s requirement. 

- Supervise the maintenance of facilities and equipment’s to ensure running in a good condition. 

- Ensure internal audits are conducted in accordance with GMP requirements. Coordinate the external audit. 

- Ensure proper handling of customer complaints to improve customer satisfaction. 

- Responsible for product quality reviews and management review. 

- Support new product development.

- QA team management. Motivate, train, coach employees, and help the members develop.

Knowledge:知识:

- Thorough knowledge of China GMP, EU GMP, and related regulations and standards in pharm industry.

-  Good communication and leadership skills.

- Good command of English in listening, speaking, reading and writing.

Capabilities能力:

- Bachelor above in pharmaceutical or related discipline.

- 5 years above experience in quality management for pharmaceutical manufacturing, 3 years above of team management experience.

- EU certification experience is preferring.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.

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