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GCP QA经理 副经理 高级专员

更新于2022-05-08
¥15000-30000
薪酬 较高
1-3年 
经验要求 一般
学历要求 一般
位置:
劲方医药科技(上海)有限公司
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B+轮 / 50-99人 / 6221次浏览

"致力于“全球新”药物开发的创业公司"

岗位职责/工作内容/岗位要求

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性质: 全职
Responsibilities:Develop, update and optimize SOPs and associated documents, ensure Policies/SOPs’ training completion and compliance of all staff, and maintain accurate documentation of SOPs and training files.Independently or under manager’s oversight to prepare internal audit plan, perform internal audit, including audit agenda, system audit, process audit, vendor audit, investigator site audit etc. and release audit report according to SOP requirement.Support to significant quality issue investigation and drive corrective and preventive action (CAPA) process to ensure the company to investigate significant quality events, deviations & discrepancies, report the findings and conclusions of the investigation, conduct regularly tracking to implement and document CAPA.Support to develop training modules for various quality process sections, identify areas requiring training and ensure gaps are completely filled within given time frame.Enhance quality culture across organization. Qualifications:Bachelor’s degree or above in a life or medical / sciences or relevant scientific discipline.At least 1 year of QC or QA experience in biopharmaceutical industry.Experience in clinical operation, quality management system is preferred.Knowledge of ICH Guidelines and GxPs including regulatory requirements for the conduct of clinical development programs.Good understanding of quality management system regulations and requirements.Sound organization, communication and teamwork skills and interpersonal skills to be able to effectively interact with multidisciplinary groups as well as with vendors.Good analytical and issue identification abilities, and attention to detail.Capability to identify issue and problem solving.Good written and oral communication skill in both Chinese and English.Knowledge of PC (word, PowerPoint, excel)Self-starter with high energy level, time management, self-discipline and strong result orientationAbility to travel as needed.
首次发布时间:2021-12-08
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