Associate QA Manager

, write English emails and standard operating procedures.

掌握工作职责相关的英文法规、指南及文件的阅读，英文邮件及标准操作规程的撰写。

and authorization approval.

负责取样人员的资质确认及授权的审批。

• Responsible for validation protocol and report review, validation deviation report review.

• 负责验证方案及报告的审批，负责验证偏差报告的审批。

• Responsible for Change Control impact assessment.

负责质量变更控制的影响评估。

• Responsible for reviewing quality risk assessment reports and participating in the development of risk strategies.

负责质量风险评估报告的审核，参与风险策略的制定。

• Support response and investigation of internal and external audit, ensure audit findings are fully investigated and CAPAs are reasonable and sufficient.

支持内外部审计应答及审计发现项的调查，审核整改报告，确保发现项得到充分调查并制定合理的纠正预防措施。

• Responsible for quality system documents and CMC documents review.

负责体系文件及CMC文件的审核。

• As POC of Quality Assurance, responsible for project quality management, cross-department communication, project quality risk management, quality procedure control, change control assessment and any abnormal follow up.

作为质量保证部门的代表，负责项目质量管理，执行相关的跨部门沟通、项目质量风险管理、质量流程控制、变更评估及异常跟进。

• Follow the company EHS policy and procedure; fulfill responsibility of EHS related regulation, timely report EHS accident and risk.

遵守公司各项EHS规章制度；履行EHS相关法规责任，即使汇报EHS相关事故及隐患。

• Any other assignment as is determined by supervisor.

完成上级安排的其他工作。

Job Requirements

工作要求

Education/ Professional Qualification

学历/专业资格

Bachelor or above degree in Pharmaceutical, Chemical, Biology, Microbiological or related field.

药学，化学，生物学、微生物学或相关学科学士或以上学位

Technical/Skills Required

技术/技能需求

Have in-depth understanding of knowledge or skillset in on-site quality management and the ability to utilize the information/knowledge proficiently in problem solving, discuss with industry experts on the same level, and act as a leader/pioneer within certain scope in that specific area, including,

对现场质量管理的知识和技能有深刻的理解并能熟练运用。熟练使用该信息/知识解决问题，与其他行业专家在同一水平上进行客观交流，在该领域的一定范围内是创新者。

Have the ability to apply the information/knowledge with expanded principles, approaches, techniques and patterns to new specific scenarios, in order to develop rational solutions or make the right decisions, including,

能将以下信息/知识用于新的具体情境，包括对其原则、方法、技巧及规律的拓展，从而利用拓展的信息/知识提供合理的解决方案或做出正确的决策。包括：

NMPA GMP, EU GMP, PIC/S GMP and FDA cGMP

中国GMP，欧盟GMP，PIC/S GMP及美国GMP

Drug management regulation/Manufacturing management regulation

药品管理法/生产监督管理办法等法规

Batch record review requirements

批记录审核要求

Knowledge of Visual Inspection

人工灯检知识

Deviation and OOX investigation principle

偏差及超标/超趋势调查原理

Biological products key quality control points

生物制品关键质量控制点

Combination product key quality control points

组合产品关键质量控制点

Quality risk management process and tools

质量风险管理工具

Change Control management process and have the ability to conduct change evaluation on behalf of quality assurance

变更管理流程并具备代表质量保证进行变更评估的能力

Knowledge of phase-appropriate quality system

阶段性质量管理体系

Understand the meaning and intension of specified information/knowledge with the ability to communicate and execute in the following manner, including,

能理解以下信息/知识的内涵和意义，并正确传达和执行。包括：

Registration management regulation and so on

注册管理办法以及相关法规

Audit trail review requirements

审计追踪审核要求

Knowledge of HVAC system and process water operation and monitoring

空调系统及工艺用水系统运行及监控的基本知识

Aseptic technique and CCS

无菌技术及污染控制策略

Knowledge of tech transfer process

技术转移知识

Manufacturing Process basic knowledge

生产工艺基本知识

Key validation activities principles and related regulations, including but limited to PV, CV, VC, APS, AMV

关键验证活动原理及相关法规，包括但不限于工艺验证，清洁验证，病毒清除，无菌工艺模拟及分析方法验证

Strong logical thinking, ability to deal with, analyze and solve problems effectively.

具有较强的逻辑思维，能有效处理，分析和解决问题。

Strong communication, presentation and decision-making skills.

具有较强的沟通、表达及决策能力。

Working Experience

工作经验

At least 5 years quality management experience with bachelor’s degree or above.

本科及以上学历，至少5年质量管理工作经验。

Junior technical title, or other equivalent proof of technical competence.

初级技术职称，或等同的技术证明。

At least 1 year team management experience.

至少1年以上团队管理经验。

Language, Computer Literacy, Office Software, etc.

语言能力，电脑知识，办公软件等

Office software, including but not limited to Word, Excel, PPT and Visio or equivalent tools.

掌握办公软件，包括但不限于Word, Excel, PPT及Visio或同等功能软件。

Ability to Read English regulations, guidelines and documents related to job