南京招聘

职位描述：
*Work with cross functional project teams and vendors to produce computer systems validation plans, qualification test protocols, traceability matrices, IQ/OQ and mentor team for producing PQ scripts.
*Assist with the development of system requirements and specifications to ensure requirements that are testable and 21 CFR Part 11 requirements are represented meeting expected data integrity standards.
*Work closely with Customer QA to ensure appropriate validation of the new GxP computer system(s).
*Conduct a data integrity audit / review of proposed solutions and advise of any remediation activities.
*Facilitate computer system Design Reviews where appropriate.
*The job holder is expected to need to work outside of normal hours if required.
*Job Holder will preferably have a BS degree, or diploma, in a relevant field and experience executing protocols and specifications in the pharmaceutical industry.
*Strong background in IT within an FDA/MHRA regulated environment.
*Complete understanding and proven experience of the validation of computer systems and 21 CFR part 11 compliance and Annex 11.
*Knowledge of GxP, GAMP and regulatory guidelines.
*Understanding of key China regulatory system and experiences in Asian, EU and US Regulatory systems
*Knowledge of data integrity practices.
*Experience in the validation of SaaS solutions.
*Effective team player with a natural ability to take the lead with respect to the Quality aspects, in Computer System Validation project teams.
*Outstanding interpersonal, communication and influencing/negotiating skills; high level of professional credibility with the skills required to develop strong alliances and partnerships, internally and externally.
*Strong analytical approach, excellent problem solving capabilities and the ability to debate issues in a constructive manner.
*Energetic with genuine enthusiasm for the role and driven in approach.
*Experiences in working with cross-functional teams in a multicultural environment
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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.