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临床QA主管/经理

ID:1000740202 分享到微信

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  • 五险一金
  • 绩效奖金
职位信息
  • 启动日期:2020-03-30
  • 招聘部门:管理
  • 汇报对象:无
  • 下属人数:无
  • 职位描述:
  • 1. Conduct, on a regional level, GCP audits of clinical studies, suppliers, and documents (such
    as protocols, Patient Information Sheet/Informed Consent Document, Monitoring) to assess
    whether all aspects of the clinical investigation and internal processes are in compliance with
    applicable regulatory requirements and established company procedures. This will include
    interviews with, and feedback to, Principal Investigators, who may be key opinion leaders in a
    particular therapeutic area. Provide timely feedback by means of the audit report, assess and
    approve corrective/preventive actions proposed by responsible parties, and contribute quality
    compliance data for metrical analysis.
    2. Manage clinical study site and supplier audit activities for less complex projects on a regional
    basis: interact with study managers to develop and refine audit plans for less complex projects;
    interact with the respective Head of Study Audit Management to ensure agreement, tracking,
    and fulfillment of the audit plan; develop audit tools (such as audit checklists); review draft audit
    reports; and prepare and distribute the Study Audit Summary Reports summarizing all
    significant study audit findings for use by the product development teams in the development of
    the Clinical Study Report.
    3. Participate in GCP/GxP IT System Audit teams by assisting in the development of the audit
    plans, developing tools for conducting such audits, conducting the audit, and reporting the
    results as a co-auditor, if assigned
    4. Contacts the local medical department to arrange a presentation of the data, makes the
    presentation and provides general advice on process improvements with instruction by Global
    Clinical Auditor/line manager/mentor.
    5. Participate in regulatory authority pre-, during-, and post-inspection activities as needed and
    requested by GDQ management (e.g. working alongside a Global Clinical Auditor as an
    Inspection Committee member, providing basic advice on preparations for inspections, assisting
    in the conduct of pre-inspection audits, and/or serving other roles as defined by the Inspection
    Committee or GDQ committee representative) to promote the successful outcome of the
    inspection.

职位要求
  • 年龄要求:25-50岁

    工作年限:3年以上

  • 学历要求:本科及以上

    专业要求:制药工程类

  • 是否统招:否

    语言要求:无

企业介绍

一线欧美制药公司

一线欧美制药公司

  • 外资(欧美)
  • 1000-5000人
  • 制药/医疗

杨醒文(Clark) 猎头

顾问 | | 广州

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