DP MQA

关键职责Key Responsibilities

1. 负责 DP 生产区的常规质量监督，以确保所有良好生产规范活动（包括配制、无菌灌装、冻干、目视检查和包装）均根据 SOP 和相关规程执行。

Responsible for routine quality oversight for DP manufacturing areas to ensure all GMP activities including formulation, aseptic filling, lyophilization, visual inspection, and packaging are executed based on SOPs and related procedures.

2. 负责审查 DP 生产工艺文件，包括但不限于工艺流程图、物料清单、主生产记录，以确保符合法规和公司程序。

Responsible for the review of DP manufacturing processes documents including but not limited to PFD, BOM, MBR to ensure the compliance with regulation and company procedures.

3. 负责DP区域现场质量监控。

Responsible for on-site quality monitoring in DP area.

4. 负责执行审核批记录、电子数据审查。

Responsible for batch record and e-data review.

5. 负责 DP 生产相关 SOP、QRA等文件审核。

Responsible for reviewing DP manufacturing-related SOPs, QRA, etc.

6. 支持客户和监管稽查和检查。

Support client and regulatory audit and inspection.

7. 参与 DP 生产区相关质量趋势分析和改进。

Participate in DP manufacturing area related quality trending analysis and improvement.

8. 完成直线经理及以上人员分配的其他任务。

Complete other tasks assigned by line manager and above.

资质Qualifications:

1. 相关领域（例如，生物学、化学、药学、工程部）本科或以上学历或同等经验。

Bachelor’s degree or above in a relevant field (e.g., Biology, Chemistry, Pharmacy, Engineering) or equivalent experience.

2. 至少4年生物制药行业QA、DP生产或 DP MSAT 工作经验。

At least 4 years of experience in a QA, DP production or DP MSAT role within the biopharmaceutical industry.

3. 了解无菌制剂和质量保证。

Understand sterile products and Quality Assurance.

4. 能够在快节奏、动态的环境中有效工作。

Ability to work effectively in a fast-paced, dynamic environment.

5. 良好的英语读写能力。

Good English reading and writing, great for English speaking.