长沙招聘

Primary Responsibilities:

• Ensure that QA audits of clinical trial data are conducted in order to assure compliance with ChinChoice or Sponsor SOPs, study protocols, Good Clinical Practice guidelines, relevant regulations requirements.

  确保临床试验QA稽查的实施，以保证临床试验运营遵循昆翎公司或申办方的SOPs、试验方案、GCP、相关指南及法规的要求。

• Maintain Quality Management System.

  维护质量管理体系。

• Confidentiality

  保密性

The identity of the subject and any information about the sponsor shall not be disc losed to unauthorized persons or groups

不允许向未经授权的个人或团体泄漏受试者身份信息和申办者任何信息。

The identity of the ChinChoice any information shall not be disclosed to unauthorized persons or groups

不允许向未经授权的个人或团体泄漏昆翎的任何信息。

Secondary Responsibilities:

• Conduct quality assurance activities and projects for clients according to ChinChoice departmental or customer policies and procedures within budget and established timelines scheduling, conducting, reporting and closing audits. If necessary, the QA manager shall write the audit- plan for the audit.

根据昆翎公司QA部门或者客户的政策条款和规程，在预算范围内为客户实施质量保证活动和项目稽查，包括稽查的时间表、实施、报告和关闭稽查。

如果有必要，QA经理将撰写一个项目稽查计划。

• Conduct ensure trial quality, periodically internal audit (investigational site audit and/or TMF audit/ system audit) for clinical trial operating and management on one’s own. To involve in making audit plan, audit implementation, issue audit report and CAPA-follow up. If necessary, the QA manager shall write the annual quality assurance plan for internal audit.

对临床试验运营和管理，通过独立地实施和确保临床试验的质量，包括定期的内部稽查(研究中心稽查和/或TMF稽查/系统稽查)。参与稽查计划的制定、稽查的实施、稽查报告发布和CAPA的跟踪。如必要，QA经理应撰写内部稽查的质量保证年度计划。

• Reviewing and tracking all the audit response report and provide training to project team member in terms of audit findings.

  审核和跟踪所有稽查发现回复，给项目团队成员提供稽查发现的培训。

• Reviewing and auditing periodically personnel training record, JD, CV to ensure that are integrity and updating timely.

  定期审核和稽查员工个人培训记录、JD\CV，确保其完整性并及时更新。

• Take participate in SOP updating in English and Chinese.

  参与中文和英文SOPs的更新。

• Involving in inspection of on sites actives.

  参与现场检查活动。

• As a Leader-auditor perform vendor or assessment.

  作为主稽查员实施供应商评估。

• As a Leader-auditor perform third party audit as client request.

  根据客户需求，作为主稽查员实施第三方稽查。

• Role of a Mentor for the supervisor auditors.

  为QA主管提供工作指导。

• Take part in the project management
  参与项目管理。

• Good at communication skill cross-department

良好的公司内部跨部门沟通能力。

• Able to write work instructions / guidelines

能够撰写WI。

• According to the regulations reviewing and revising SOPs form

  能够根据法规的要求审核和修改SOP的表格。

• Other tasks assigned by QA director.

  QA总监分配的其他工作。

Qualifications

任职资格

1. A bachelor degree (or above) in a medicine, life science and/or other relevant discipline.

2. 医学、药学、生命科学和/或其他相关学科学士及以上学位。

3. 6 years at least experience in pharmaceutical, related area (over 3 years in Quality Assurance experience) preferably within a GCP environment or equivalent combination of education, training experience.

   至少6年的制药企业或相关领域的工作经验(3年以上质量保证经验)，***是GCP环境或同等教育背景和培训经历。

4. Knowledge, understanding and experience in applying ICH/FDA/local regulations of GXP and Guidelines.

   在知识、理解、应用ICH/FDA /地方GCP和法规、GXP和指导原则有经验。

5. Demonstrated ability to handle multiple training to operation team.

   具有胜任对运营团队进行多重培训的能力。

6. Good communication and interpersonal skills required.

   需要良好的沟通和人际交往能力。

7. Ability to work effectively and carefully in a team environment.

   具备在团队环境中有效地、仔细地工作能力。

8. Good at writing and speaking in English and Chinese.

   擅长的中文和英文书写和演讲。

9. Good at using Microsoft office software.

   擅长使用微软Office办公软件。

10. It is priority person who got QC or CRA or PM experience at 5 years.

有5年QC或CRA或项目经理经验者优先。

昆翎（ClinChoice）是一家致力于为生物医药和医疗器械客户提供高品质一站式服务的临床阶段CRO，服务包括临床运营、项目管理、生物统计、数据管理、注册事务、医学事务和药物警戒。昆翎已经在中国、美国、欧洲、印度、日本和菲律宾建立了主要的临床交付中心，目前在全球拥有1800多名员工，其临床运营团队覆盖了亚、欧、北美等七个国家和地区。

高盛直投部董事总经理、昆翎董事会成员许小鸥先生认为，“随着创新疗法在全球的增长，CRO公司提供高效、可靠的研发服务能力变得尤其重要。昆翎独特的价值主张结合了其对于本地市场的了解、国际药物研发的经验以及高效的团队执行能力。我们坚信公司强劲的管理层团队以及其高效的执行能力，将为昆翎的发展开启新的篇章。

昆翎是一家全球化的临床合同研究组织 (“CRO”)，在亚洲、北美洲和欧洲七个不同国家和地区拥有超过1800名临床研究专业人员。在全新品牌战略的引领下，昆翎将以“立足中国，服务全球”为己任，继续为全球制药、生物科技和医疗器械公司提供高质量、全方位服务的临床研究服务