1.作为CSV项目经理, 在项目实施中承担项目经理的角色,负责规划、协调项目的实施,把控项目实施的质量;

2. 了解客户需求，根据客户需求修改/编写VP/URS/CS/RA;

3. 在标准IQOQ基础上，修改/编写补充IQP/OQP/PQP文件，并测试执行;

4. 处理不合格/偏差项，编写RTM/VSR;

5. 解答客户有关CSV的疑问;

任职条件:

1. 3年以上制药行业工作经验，了解制药质量管理体系;

2. 完整的验证项目实施经历,可独自承担项目经理职责,有验证文件编写经验;

3. 了解CSV相关法规，如CFDA GMP/EU GMP/21CFR Part11,Part210,Part211;

4. 熟悉CSV相关指南如ISPE GAMP5;

5. 良好的沟通能力,能及时明确客户的具体需求;

6. 了解安捷伦各软件产品;

7. 积极主动,较强的学习能力,有意愿学习新的业务;

上班地址：虹口区四川北路1350号利通广场

Agilent is a leader in life sciences, diagnostics and applied chemical markets. The company provides laboratories worldwide with instruments, services, consumables, applications and expertise, enabling customers to gain the insights they seek. Agilent’s expertise and trusted collaboration give them the highest confidence in our solutions.

Agilent focuses its expertise on six key markets, where we help our customers achieve their goals:

Food: Agilent helps ensure that our global food supply is free of contaminants—whether chemical, viral, bacterial or microbiological. Our customers include government regulators and labs that control food safety, as well as private companies that produce, package and sell food to the public.

Environmental and Forensics: From pesticides to pharmaceutical residues to trace metals, we provide fast, accurate and sensitive methods for monitoring contaminants affecting quality of life. Agilent solutions also play an important role in law enforcement by providing robust tools and instruments to analyze and verify evidence at trial, and keeping the world’s top-performing athletes honest.

Pharmaceutical: Agilent has one of the broadest solutions portfolios of any company serving the pharmaceutical industry. Our solutions provide precise answers for every segment of the pharmaceutical industry, from disease research and drug discovery to drug development, manufacturing and quality control. The start-to-finish solution set means customers can get products to market faster. Customers trust us to help them test the purity of their therapeutics. Agilent also ensures that their instruments and processes conform to the highest compliance regulations.

Diagnostics: Agilent gives doctors a head start in the fight against cancer and other diseases. Our solutions help pathology laboratories deliver fast, accurate information to the doctors, hospitals and medical centers they serve. We help medical professionals make more accurate diagnoses so patients can receive the most effective therapies.

Chemical and Energy: The world runs on energy, and energy companies need to locate, extract and refine fuels efficiently and cost-effectively. Our solutions help customers maximize their production and predict failures in their refineries before they happen. Agilent also helps energy researchers investigate biofuels, renewable fuels and other forms of alternate energy.

Research: Most life sciences and diagnostics research is done at top-tier universities, with funding from governments around the world. Agilent is helping these researchers learn more about cancer, cardiovascular diseases, diabetes, Alzheimer’s, Parkinson’s, autism and other ailments. Our instruments, software and sample preparation solutions help scientists conduct faster, more accurate research.

AGILENT RESEARCH LABORATORIES

The purpose of Agilent Research Laboratories is to power Agilent’s growth through breakthrough science and technology.

To complement our product line R&D, Agilent Labs looks beyond the evolution of current products and platforms to create the technologies that will underlie tomorrow’s breakthroughs, enabling Agilent customers to answer questions at the leading edge of life science, diagnostics and the applied markets. Our horizon is broad, encompassing synergies across Agilent and seeding new businesses to create competitive differentiation and compelling value for current and future customers and shareholders.

To accomplish these goals, we attract and retain top technical talent, collaborate extensively with global research leaders in academia, government and industry, and promote a culture of innovation and teamwork across our highly multi-disciplinary staff of life scientists, physical scientists and engineers. The majority of our research is located in the United States in Santa Clara, California, with additional locations in Europe and Asia.