大兴区
职位详情
工作内容：
1. 客户审计支持。
Client Audit Support.
1.1 收集客户审计所需的项目信息及相关文件资料。
Responsible for gathering project information and required documentation ahead of client audits.
1.2 协助客户审计实施过程，协调各部门领域专家回应审计人员提问。
Support the execution of client audits and coordinate departmental SMEs to address auditor inquiries.
1.3 接收客户出具的审计报告，按责任部门对发现项进行分类，并组织相关部门制定整改回复。
Receive audit reports from clients, categorize observations by department, and coordinate relevant teams to prepare responses.
1.4 汇总并审核各部门提交的回复内容，整合后将最终答复发送至客户。
Collect and review draft responses from departments, finalize the reply package, and submit it to the client.
1.5 负责质量管理体系中纠正与预防措施的审阅、归档及闭环跟踪，并依据双方约定及时向客户反馈CAPA进展。
Review, archive, and track CAPAs within the quality management system, and provide timely updates to clients as agreed.
2. 质量协议维护与管理。
Quality Agreement Maintenance and Management.
2.1 负责质量协议模板的日常维护与版本更新。
Responsible for maintaining and updating the quality agreement template.
2.2 牵头开展质量协议审核工作，组织相关部门参与评审，并汇总意见后反馈客户。
Lead the review of quality agreements, involve relevant departments in evaluation, and consolidate feedback to client.
2.3 根据与客户达成的一致要求或公司SOP规定，定期完成质量协议的修订与更新。
Update quality agreements in accordance with mutual agreements or internal SOPs.
2.4 在签署质量协议的项目启动阶段，负责对项目相关人员开展协议内容培训。
Provide training to project personnel upon project initiation involving a signed quality agreement.
2.5 对已签署的质量协议按类别进行归档保存。
Classify and archive executed quality agreements.
3. 客户调查问卷填写与归档。
Filling and Archiving the Questionnaire from client.
3.1 填报客户发送的各类调查问卷，并在完成后提交给客户。
Complete questionnaires issued by clients and return them upon completion.
3.2 对已完成的问卷及其附件材料进行系统化存档。
Systematically archive completed questionnaires along with supporting documents.
4. 负责内部审核的策划、组织与实施。
Responsible for planning, organizing, and executing internal audits.
5. 负责CAPA流程的跟进与管理。
Responsible for CAPA follow-up and management.
6. 负责法规动态追踪，并适时开展合规差距分析。
Monitor updates of GMP regulations or guidance documents and conduct gap analysis when necessary.
7. 其他 Other
7.1 完成部门主管交办的临时性工作任务。
Carry out ad-hoc tasks assigned by the department head.
教育背景及任职资格：
1. 教育背景：化学、应用化学、药学或相关专业本科及以上学历。
Education Background: bachelor degree or above in Chemistry, Applied Chemistry, Pharmacy or other related majors.
2. 经验：须具备药学或相关专业本科学历（或具有中级专业技术职称或执业药师资格），并拥有至少3年药品生产或质量管理实际工作经验，接受过所生产产品相关的专业知识培训。
Experience: Must hold a bachelor’s degree in Pharmacy or related field (or possess intermediate technical title or Licensed Pharmacist qualification), with minimum 3 years’ practical experience in pharmaceutical manufacturing or quality control, and have received professional training related to the products manufactured.
3. 技能技巧：具备一定的专业英语读写能力，需持有大学英语六级证书。
Skills: Possess solid English reading and writing skills in professional context; CET-6 certification is required.
1. 客户审计支持。
Client Audit Support.
1.1 收集客户审计所需的项目信息及相关文件资料。
Responsible for gathering project information and required documentation ahead of client audits.
1.2 协助客户审计实施过程，协调各部门领域专家回应审计人员提问。
Support the execution of client audits and coordinate departmental SMEs to address auditor inquiries.
1.3 接收客户出具的审计报告，按责任部门对发现项进行分类，并组织相关部门制定整改回复。
Receive audit reports from clients, categorize observations by department, and coordinate relevant teams to prepare responses.
1.4 汇总并审核各部门提交的回复内容，整合后将最终答复发送至客户。
Collect and review draft responses from departments, finalize the reply package, and submit it to the client.
1.5 负责质量管理体系中纠正与预防措施的审阅、归档及闭环跟踪，并依据双方约定及时向客户反馈CAPA进展。
Review, archive, and track CAPAs within the quality management system, and provide timely updates to clients as agreed.
2. 质量协议维护与管理。
Quality Agreement Maintenance and Management.
2.1 负责质量协议模板的日常维护与版本更新。
Responsible for maintaining and updating the quality agreement template.
2.2 牵头开展质量协议审核工作，组织相关部门参与评审，并汇总意见后反馈客户。
Lead the review of quality agreements, involve relevant departments in evaluation, and consolidate feedback to client.
2.3 根据与客户达成的一致要求或公司SOP规定，定期完成质量协议的修订与更新。
Update quality agreements in accordance with mutual agreements or internal SOPs.
2.4 在签署质量协议的项目启动阶段，负责对项目相关人员开展协议内容培训。
Provide training to project personnel upon project initiation involving a signed quality agreement.
2.5 对已签署的质量协议按类别进行归档保存。
Classify and archive executed quality agreements.
3. 客户调查问卷填写与归档。
Filling and Archiving the Questionnaire from client.
3.1 填报客户发送的各类调查问卷，并在完成后提交给客户。
Complete questionnaires issued by clients and return them upon completion.
3.2 对已完成的问卷及其附件材料进行系统化存档。
Systematically archive completed questionnaires along with supporting documents.
4. 负责内部审核的策划、组织与实施。
Responsible for planning, organizing, and executing internal audits.
5. 负责CAPA流程的跟进与管理。
Responsible for CAPA follow-up and management.
6. 负责法规动态追踪，并适时开展合规差距分析。
Monitor updates of GMP regulations or guidance documents and conduct gap analysis when necessary.
7. 其他 Other
7.1 完成部门主管交办的临时性工作任务。
Carry out ad-hoc tasks assigned by the department head.
教育背景及任职资格：
1. 教育背景：化学、应用化学、药学或相关专业本科及以上学历。
Education Background: bachelor degree or above in Chemistry, Applied Chemistry, Pharmacy or other related majors.
2. 经验：须具备药学或相关专业本科学历（或具有中级专业技术职称或执业药师资格），并拥有至少3年药品生产或质量管理实际工作经验，接受过所生产产品相关的专业知识培训。
Experience: Must hold a bachelor’s degree in Pharmacy or related field (or possess intermediate technical title or Licensed Pharmacist qualification), with minimum 3 years’ practical experience in pharmaceutical manufacturing or quality control, and have received professional training related to the products manufactured.
3. 技能技巧：具备一定的专业英语读写能力，需持有大学英语六级证书。
Skills: Possess solid English reading and writing skills in professional context; CET-6 certification is required.
2026-07-26 13:21
IP属地：北京
职位福利
本科3-5年QA检验QA审核QA认证
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