质量副经理/高级主管

- 进行仓库质量运作整体管理，确保柯乾临床供应链运营符合质量要求。

Responsible for the overall management of warehouse quality operation to ensure that the operation of ClinsChain clinical supply chain meets the quality requirements.

- 确保质量体系工作有效进行和落实，包括但不仅限于文控、培训、偏差和投诉、CAPA、变更、供应商管理、验证和确认、校准、PPM、内审和外审、召回等。

Ensure effective implementation of quality system, including but not limited to document control, training, deviation, and complaint, CAPA, change control, supplier management, validation and qualification, calibration, PPM, self-inspection and external audit, recall, etc.

- 进行质量流程的监控和不断更新优化。

Monitor the quality process and constantly update and optimize.

- 参与支持现场质量检查工作，包括收货、贴签等

Participate in and support on-site quality inspection, including receiving goods, labeling, and packaging, etc.

- 参与内外审计，包括柯乾内审、供应商审计，以及应对国内外客户审计

Participate in internal and external audits, including ClinsChain self-inspection, supplier audit, and deal with domestic and foreign customer audit.

- 支持国际第三方仓库质量管理工作

Support international third-party warehouse quality management

- 能熟练使用英文书写质量文件，并使用英文邮件进行工作交流

Enable to draft quality related documents and communicate during work in English proficiently

经验要求

Job requirements:

- 有药品生产QA工作经验，或临床药品供应链质量管理经验

Experience in Pharmaceutical manufacturing QA or clinical drug supply chain quality management.

- 有质量主管工作经验，操作过质量管理系统，对文控、培训、偏差、变更和CAPA、供应商管理等做过独立完整的管理工作。

Working experience as quality supervisor, operating quality management system, independent and complete management of document control, training, deviation, change control, CAPA, supplier management, etc.

- 英文听说读写流利，

Fluent in English listening, speaking, reading, and writing;

- 办公自动化熟练操作。

Proficient in MS office software

- 有在MNC药企质量部门工作经验优先。

working experience in quality department of MNC pharmaceutical company is preferred.

- 工作地点：北京

Location： Beijing