岗位概述 / Job Summary:
Responsible for the establishment and management of Chem & Phy lab team and system , in line with the clinical and commercial production and release requirements, in line with the corresponding registration requirements, pharmacopoeia, GMP，EHS and bio-safety requirements
负责组建和管理质量控制理化实验室团队和体系运行，符合对应产品临床和商业化生产和放行检测要求，符合对应注册要求，药典，GMP和EHS要求。


关键职责 / Role & Responsibilities:

 实验室搭建和维护运行
 Responsible to routine management of Chem&Phy lab , meet the requirements of EHS, Pharmacopoeias, GMP, data integrity, ICH guidelines and registration负责QC理化实验室的日常管理，满足实验室安全，中美欧药典、GMP，数据完整性，ICH指南和商业化产品注册要求
 Responsible to implement routine testing of cleaning utilities, materials, in-process testing, release testing, stability study and related sampling & release activities负责组织实验室完成对于工厂洁净系统，物料系统，产品生产中控及放行和稳定性研究等理化测试活动，以及相关取样、放行活动
 Responsible to implement project required testing 负责组织实验室完成对工厂项目计划需要的测试活动
 Responsible to assure required resource for routine testing and activities 负责管理落实生实验室完成日常测试需要的资源准备工作。
 Responsible for guiding the laboratory to carry out relevant verification, change, deviation investigation, risk assessment, product review and other activities 负责管理落实实验室进行相关验证，变更，偏差调查，风险评估，产品回顾等活动
 Responsible to complete internal and external audit activities, and improvement continuously 负责管理实验室配合完成内外部审计活动，并持续改善
 Responsible for promoting and maintaining the establishment and routine operation of the quality control system information platform负责推动和维护质量控制信息化平台的建立和日常运行
 Responsible for promoting the lean operation in Bio-assay Lab 负责推动实验室的精益管理
 Responsible for technical exchanges, cooperation and communication with external stakeholders负责同外部相关方的技术交流， 合作和沟通
 Team management 团队建设和管理
 Build up team per business and regulation need 按照业务需要和法规要求搭建团队
 Coach and develop team and members, establish the training and development system in QC 带教和发展团队及成员, 在QC 建立完善培养系统
 Others 其它
 Undertake other projects and task per company and department request 承接公司和部门对应项目和任务要求

教育和关键能力的要求 / Education and Qualification:

 Min. 8-10 years working experience in pharmaceutical companies, min. 5-7 years of laboratory management experience for sterile product, relevant professional background, and ability to read, write and speak English 至少8-10年以上医药企业质量管理工作经验， 至少5-7年以上无菌产品实验室管理经验，具备相关专业背景，具备英文读写说能力
 Familiar with relevant pharmacopoeia method requirements and routine operation, familiar with the operation of laboratory equipment, such as chromatographic systems and/or biochemical analysis equipment etc. 熟悉相关药典方法要求和日常操作，熟悉相关实验室设备操作，比如各类色谱系统和或生化分析设备等
 Familiar with NMPA, EU, USFDA GMP requirements, experience of EU and FDA inspection, familiar with QMS and LIMS operation 熟悉国内和欧美对应GMP要求，有欧美GMP检查经验，熟悉质量信息化系统和实验室信息化系统操作
 Familiar with the whole life cycle management of test methods, laboratory construction / relocation project , process technical transfer project, Lab error investigation and material deviation, etc. 熟悉实验室方法全生命周期管理， 实验室新建/搬迁，工艺项目转移，实验室偏差和各类物料偏差调查等
 Integrity, Accountability and Teamwork 诚实守信，有主人翁精神和团队合作意识
 Experience in laboratory management is preferred; or experience in process & quality comparability study during registration stage or post-approval change of bio-products is preferred. 有实验室管理经验的优先考虑；或有生物产品注册阶段或上市后工艺和质量可比研究经验的优先考虑