QA Specialist
百特(中国)投资有限公司
- 公司规模:500-1000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2019-05-14
- 工作地点:北京
- 招聘人数:1人
- 工作经验:3-4年经验
- 学历要求:本科
- 职位月薪:6-8千/月
- 职位类别:质量管理/测试工程师(QA/QC工程师) 供应商管理
职位描述
About Baxter
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anaesthetics; and pharmacy automation, software and services. The company’s global footprint and diacritical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medicalbreakthroughs to advance the next generation of healthcare innovations thatenable patient care.
What You’ll Be Doing
It’simpossible to list everything you’ll do here because every day is different.But a few things are clear, you’ll:
Greater China Document Management
(1)Establish procedure for Greater China document management and implementation. Act as 1Qsys Rep to take following responsibilities to ensure implementation:
System operation for document creation, revision, obsolescence etc.;
Prepare gap analysis and implementation forms for Greater China SME; Support Greater China SME to perform gap analysis and implementation;
Work as single contact between Global/AP and sub-entities for global QMS implementation;
Provide support in document creation, revision, obsolescence, gap analysis, training and implementation;
Issue document periodic review list yearly;
Maintain Greater China SME generation, change, and periodic review and Greater China & Sub-entity SME list;
Other un-routine document management works.
Greater China Supplier Quality Management
(1) Work as Greater China coordinator between Global/AP and sub-entities,
Coordinate supplier management CQPs review for new/revised, compile comments and questions from greater China, communicate with AP/global as coordinator;
Coordinator between AP and China plants for supplier management related issue, such as annual supplier re-evaluation, China supplier risk assessment, supplier management system training.
Prepare and monitor Greater China lead supplier auditor qualification plan
(2) Technical support for Track Wise Quality Tracking System (for supplier management) operation;
(3) Other temporary task for supplier management.
Post market surveillance work for medical device:
(1) Maintain and improve the adverse events handling process based on the new regulation requirement
(2) Streamlining MDR reporting process adapting to the new regulation environment.
(3) Reporting and follow up the adverse events(MD)until the AE closure
Greater China Regulatory Compliance:
(1) Track and notify the regulatory updating, summarize in monthly report.
(2) Coordinate new/update regulation gap analysis and draft regulations comment collection.
Do you have what takes to build a career here?
(1) Bachelor’s degree or higher in Chemistry / Pharmacy / Microbiology / Medicine or a related scientific discipline;
(2) 2~5 years’ experience in the Pharmaceutical or related industry.
(3) Strong understanding of and experience in quality management systems;
(4) Good knowledge on effective quality documentation systems;
(5) Full competency in local language and a working knowledge of English;
(6) Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook.
Why Baxter?
A Career That Matters
Baxter’s employees are united in a mission to save and sustain lives. We are passion at eabout applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating incrucial areas of unmet need, and pursuing creative collaborations that bringour mission to life for patients every day.
Apply today and experience a career that matters!
Baxter is an equal opportunity employer and makes employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other status protected by law.
职能类别: 质量管理/测试工程师(QA/QC工程师) 供应商管理
公司介绍
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.
联系方式
- Email:TTA@baxter.com
- 公司地址:杭州