DS QA 原液生产QA

JOB RESPONSIBILITY -Responsible as QA in the Quality Management System covering the following areas: 负责质量管理体系中质量保证相关工作的执行，涵盖以下领域： • Drug substance manufacturing, technical transfer and process control 原液生产、技术转移和工艺控制 • Facility and Equipment 厂房和设备 • Cell Bank management 细胞库管理 • Clean zones environment control 洁净区环境控制 • Garment management for clean areas 洁净区洁净服的管理 - Interface with business units to participate in sustainability and continuous improvement of compliance and quality functions 对接业务部门，参与合规和质量职能的可持续性和开展持续改进。

• Responsible for quality oversight to DS manufacturing and Cell Bank; 负责原液生产、细胞库，提供质量监控；

• Participate in the investigation of any events occurring in the DS manufacturing, cell bank, review quality events and changes, ensure that all events have been adequately investigated and assessed, and take appropriate CAPA as necessary 参与调查处理原液生产、细胞库发生的任何事件，审核质量事件和变更，确保所有事件达到充分的调查和评估，并采取必要的合适的纠正预防措施；

• Responsible for reviewing quality related documents, eg: MBR, BPR,QRM, etc.; 负责审核质量相关文件，例如：主生产记录、批生产记录、质量风险评估等；

• Review the batch release package for drug substance , ensure the released drug substance meet the requirement; 审核原液批放行相关的文件，确保所放行的原液满足要求；

• Responsible for controlled distribution and recovery of BPRs; 负责批生产记录的受控发放和回收；

• Involved in the technical transfer process, review new product introduction related documents; 参与技术转移，审核新产品引入相关文件；

• Involved in process validation, continuous process verification and process optimization related activities, review related documents; 参与工艺验证、持续工艺确认及工艺优化相关的活动，审核相关的文件；

• Responsible for review of manufacturing equipment lifecycle process documents, e.g. equipment URS, equipment validation, etc.; 负责生产设备生命周期流程文件的审核，例如，设备URS，备验证等；

• Review the validation documents, such as FVMP/FVSR, cleaning validation, shipping validation, related sterilization/decontamination/sanitization validation, etc. 参与审核验证文件，例如：FVMP/FVSR、清洁验证、运输验证、相关灭菌/去污染/消毒验证等 • Responsible for reviewing electronic data to oversight into the implementation of data integrity strategy; 负责对电子数据进行审核以监督数据完整性策略的执行；

• Participate into the implementation of quality and compliance procedures for computerized systems, equipment and instruments to ensure served a continuous validation status. 参与监督计算机化系统、设备和仪器按照质量与合规流程应用，保证系统、设备和仪器始终保持持续验证状态。

• Review pest control relevant GMP document's review and monitor the pest control measures implementation; 审核虫害控制相关的GMP 文件，监督虫害控制措施的实施； - Complete other tasks assigned by line manager or above. 完成上级领导安排的其他任务

教育程度/经验Education background/ Experience - Bachelor degree or above (preferably Biology or Chemistry or Bio-engineering) plus a minimum of 3 years’ experience in medical device or pharmaceutical manufacturing 本科及以上(生物学或化学或者生物工程专业优先)，需至少3年医疗设备或医药制造相关经验； - Have relevant knowledge to maintain the robust operation of management system or QA related work experience is preferred; 具有如下维护管理体系稳健运行的相关知识或QA工作经验者优先； - Process Knowledge 工艺知识 - Equipment and computerized system lifecycle Management 设备和计算机系统生命周期管理 - Document/Record Management 文件/记录管理 - Validation Management, including equipment validation, process validation, cleaning validation, shipping validation and so on 验证管理，包括设备验证、工艺验证、清洁验证、运输验证等 - Change control Management 变更管理 -CAPA and deviation Management CAPA及偏差管理 其他要求Other requirements -Basic GMP knowledge, understanding regulatory guidelines and operational knowledge of pharmaceutical companies such as NMPA, Eudralex, PIC/S and US-FDA; 基础的GMP知识，了解NMPA, Eudralex, PIC/S和US-FDA等制药企业法规指南和运营知识； - Understanding the Quality Management Systems; 了解质量管理体系； - Proper ability to investigate and solve technical problems; 具备一定的调查和解决相关技术问题的能力； - Good English reading and writing ability. 良好的英文读写能力