岗位职责:

项目阶段：

1.根据合全药业质量体系要求为无锡工厂的新增系统进行系统分类，并作为验证主题专家参与系统风险评估、软硬件分类评估及电子记录与签名分类评估工作。

2.根据合全药业验证体系要求与模板为新增直接影响系统（工艺设备）起草设计/安装/运行/性能确认方案并对执行人员进行培训，组织协调确认的执行和报告，管理确认中发现偏差。

Project Phase:

1.According to the requirements of STA Quality System, organize the system classification of newly added systems in Wuxi Plant, and participated in the system risk assessment, software and hardware classification and electronic record and signature assessment as validation subject matter experts.

2.Draft the design/installation/operation/performance qualification protocol for the newly added direct impact system (process equipment) according to the requirements and template of STA Validation System and train the executors, organize and coordinate the implementation and reporting, and manage the deviations identified in validation.

运营阶段：

1.根据工厂年度验证主计划或变更组织实施再确认工作。

Operational Phase:

1.Perform revalidation according to the site

s annual Validation Master Plan or Change.

流程管理：

1.设备性能确认策略的建立，维持和持续优化。

2.设备性能确认相关SOP的维护和持续优化。

3.作为验证主题专家，从专业知识及执行经验出发对现有验证体系提出合理的改进与补充意见，与质量部门共同保证质量体系的持续改进。

Procedure Management:

1.Establishment, maintenance and continuous optimization of equipment performance qualification strategy.

2.Maintenance and continuous optimization of SOP related to equipment performance qualification.

3.As the subject matter expert of validation, propose reasonable improvement and supplementary opinions on the existing validation system based on professional knowledge and implementation experience, and work with the quality department to ensure the continuous improvement of quality system.

审计支持：

1.与质量部门合作，作为验证主题专家支持公司客户审计以及监管审计。

2.对审计发现项进行回复并改进，确保持续优化。

Audit Support:

1.Partners with Quality to support customer and regulatory audits as a Validation Subject Matter Expert.

2.Response and improve audit findings to ensure continuous optimization.

上级主管安排的其他工作。

Other work arranged by superior supervisor.

任职要求:

1. 制药、化学、工程、设备、自动化相关专业本科及以上学历。

Full-time bachelor degree or above in Pharmacy, Chemistry, Engineering, Equipment and Automation

2. 具有设备确认和验证工作经验。

对于GMP和行业良好的验证实践规范有较完整的理解。

了解常见口服固体制剂设备的工艺和设计。

Have experience in qualification and validation of process equipment.

Have a good understanding of GMP and industry good validation practices.

Understand the process and design of common oral solid dosage equipment

3. 基本英文读写能力。

Basic English reading and writing skills.