北京 [切换城市] 北京招聘北京生物/制药/医疗器械招聘北京药品生产/质量管理招聘

Audit Manager, QA & Compliance

科文斯医药研发(北京)有限公司上海分公司

  • 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:2015-06-12
  • 工作地点:北京-朝阳区
  • 招聘人数:1
  • 工作经验:8-9年
  • 学历要求:本科
  • 语言要求:英语熟练
    英语熟练
  • 职位月薪:面议
  • 职位类别:其他  药品生产/质量管理

职位描述

Essential Job Duties:

? Manage and maintain the audit scheduling and tracking system for global QA&C
? Coordinate planning and scheduling of all QA&C audits in conjunction with Global QA Project Leads
? Drive completion of audit reporting within agreed timeframes
? Provide oversight of CAPA follow up for all findings, particularly Critical and Major findings
? Provide tracking metrics to senior management, functional management and other appropriate parties.
? Review RFPs and RFIs and work with the Senior Director to provide QA input
? Obtain information about new business wins and provide audit plans in liaison with the global QA Project Lead for the client.
? *Liaise with clients as required for standalone audit work.
? *Other duties such as participating in audits as required to support the department.

Experience:

Minimum Required:
3 years experience in Clinical Quality Assurance, preferably within a GCP environment.
5 years experience in pharmaceutical/CRO industries.
Other required work-related experiences.
? Proven ability to understand, analyze and communicate the impact of global regulatory issues affecting the drug development process
? Financial understanding of global clinical development budgets
? Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
? Knowledge of the drug development process from the perspective of a contract research organization

Education/Qualifications/Certifications and Licenses

Minimum Required:

? University/college degree, BA/BS (life science preferred) or equivalent experience

公司介绍

Covance is one of the world’s largest and most comprehensive drug development services companies with more than 10,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.

Well come to our online job pool to dig out more opportunities at:
http://careers.covance.cn/

联系方式

  • 公司网站:http://www.covance.com
  • Email:calvin.xu@covance.com
  • 公司地址:上海市黄埔区西藏中路268号来福士广场1806室
  • 邮政编码:200001
  • 联系人:Vicky Qu