药企中国GMP负责人
面议
预约职位
工作性质全职
职位类别医药研发/生产/注册
招聘人数1人
学历要求本科
工作经验10年以上
性别要求
用工形式合同制
技能等级高级专业技术职务
年龄要求不限
试用期六个月
试用期薪资面议
工作地点泰州医药高新技术产业开发区/医药城
职位描述
- Responsible for submission of applications to China regulatory authorities. - Coordination with CFDA/other regulatory authorities related to all activities (submission, GMP audit, audit response submission and compliance, renewals etc…). - Responsible for verification of Chinese pharmacopeial compliance of specifications/requirements etc... - Should be able to prepare process flow chart, collinear assessments etc… for the products. - Should have knowledge on manufacturing/packing process. - Responsible for coordination of External trainings related to Chinese regulatory. - Responsible to coordination with Site regulatory, production, administration, QC etc.. teams to ensure/collect the required information/documents etc.. - Responsible to ensure the Chinese language terminologies/requirements for documents aligned for Chinese regulatory. -负责向中国监管机构提交申请。 -协调与CFDA/其他监管机构所有活动(提交、GMP审计、审计回复提交和合规、续期等) -负责确认中国药典规范/要求等的合规性等 -应能够为产品准备工艺流程图、共线评估等。 -应了解生产/包装工艺。 -负责协调与中国监管相关的外部培训。 -负责协调现场合规、生产、行政、质量控制等团队,确保/收集所需的信息/文件等。 -负责确保文件的中文术语/要求符合中国监管要求。
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