长沙招聘

工作职责:

Performs quality control on the information in quality systems and the information/ documents received from responsible contacts in quality systems

Liaises with responsible contacts, document owners, stackholders and/or other end users to resolve quality system related information/documentation discrepancies and issues. Communicate with stackholders and escalate issues to the quality system operations

Support Study Team/ functional lines to ensure system/ document quality requirements are agreed to and met, according to Completeness, Timeliness and Quality metrics

Contributes to process improvements and additional special projects that may arise

Analyzes error trends in quality system/ documentation and provides feedback to their management and the quality system operations to enable continuous improvement

Actively identifies continuous improvement opportunities to enhance operational efficiencies through process and metrics analysis

任职资格:

Provides support and guidance to the Study Teams/ functional lines to drive performance against metric targets

Applies lessons learned to continuous improvement of quality system and documentation management practices across study teams and/or related functional lines

Provides education, feedback and support to Study Teams/ functional lines in order to build knowledge and awareness of good quality system and document management practices for clinical trials

Being the Subject Matter Expert of Quality system Checking

Supports the preparation of appropriate audit and inspection responses

Contributes to the quality system development process if needed

Fully and proactively support development China business needs

On October 31, 2005, Pfizer announced the official opening of China Research and Development Center (CRDC) in Shanghai. Pfizer Global Research and Development’s Center is mainly engaged in drug development activities. Much of the facility's capacity is devoted to the study design, data management and statistical analysis of global phase I-IV clinical trials, as well as the clinical study report process. In addition, CRDC is a part of Pfizer global Safety and Risk Management and covers the functions of safety data processing and assessment. The center also trains Pfizer employees in China and throughout the Asia region in internationally recognized Good Clinical Practice standards.
辉瑞公司于2005年10月31日宣布辉瑞中国研发中心正式在上海揭幕。辉瑞中国研发中心主要为全球辉瑞药物开发提供支持工作。大部分的功能是围绕在I-IV期临床试验研究设计、数据管理和生物统计分析、以及临床试验报告的部分准备工作。此外，该中心是辉瑞全球安全和风险管理部的一个分支，负责安全数据处理和评估工作。研发中心还将为辉瑞公司在中国及亚洲的其它运营部门的员工提供国际标准的临床试验管理规范(GCP)的技术培训。