工作职责:
负责建立和完善临床和商业化现场质量监督程序，确保关键质量参数和关键步骤受控，生产符合
SOP 和 GMP 要求；
Responsible for the establishment and improvement of on-site quality supervision procedures in clinical and
commercial production phase to ensure that key quality parameters and steps are controlled and production
meets SOP and GMP requirements;
负责原液产品放行包的审阅批准，确保原液放行流程符合 SOP 要求，相关文件资料准确齐全，放
行日期满足放行计划要求;
Responsible for the review and approval of the release package of DS product to ensure that the release
process of the DS product meets the requirements of SOP, the relevant documents are accurate and complete,
and the release date meets the requirements of the release plan;
带领原液 QA 团队进行生产现场质量巡检，包括不限于生产步骤关键质量控制点，厂房设施、虫害
控制、关键物料信息、物料状态确认，物料平衡和不合格品控制，对于生产车间任何异常提供质量
评估协助；
Lead the DS QA team to conduct quality inspection at the production site, including but not limited to the
production quality control points, plant facilities, pest control, material information, material status
conformation, material reconciliation and non-conforming product control, provide quality assessment
assistance for any abnormality in the workshop;
负责原液生产工艺规程、空白批记录、相关验证文件审阅和 SOP 批准，参与验证和偏差&变更活动
的质量监督；
Responsible for the review of DS process specifications, blank batch record, relevant validation documents
and SOP approval, participate in quality supervision of validation and deviation & change activities;
负责委托生产项目、受托生产项目的对接管理（包括放行）；
Responsible for the docking management of commissioned production and contracted production (including
release);
支持偏差调查、变更风险评估，产品投诉和不良反应调查等；
Support for the deviation &change risk assessment, product complaints and adverse reaction investigations,
etc.
支持公司的内审、集团检查、客户审计和官方检查，以及 CMO 审计和质量监督；
Support the internal audit, Fosun corporate audit, Client audit and Authority Inspection as well as CMO
audit and perform quality supervision on CMO;
管理、激励、培训并指导团队的工作；
Manage, encourage, train and provide guidance to the team;
任职资格:
生物，生物化学，生物制药或者相关专业本科及以上。
Bachelor degree or above in biology, biochemistry, biopharmaceutical or related major.
80 5-8 年制药企业 QA 或质量相关工作经验，熟悉生物制品现场质量监督和放行流程。
8years QA working or quality related experience in pharmaceutical enterprises, familiar with shop floor
quality supervision and release process of biological products.
80 熟悉国内外 GMP 法规要求。
Familiar with GMP regulations (Chinese and Oversea).
80 掌握常用的办公软件，及良好的英语读写能力。
Good command of office software, fluent English.
80 认真负责，结果导向，沟通能力强，团队领导意识佳，有敏锐的发现问题和解决问题的能力。
Accountability, results-driven, good communication skills, good team work, strong problem solving and
trouble shooting.