SMQC运营管理员

岗位描述：

Job Description:

1、负责SMQC运营相关工作的日常执行与协调，包括运营计划跟进、资源需求沟通、任务进度追踪及交付支持，确保相关工作安全、合规、及时完成。

Responsible for the daily execution and coordination of SMQC operation-related activities, including operation plan follow-up, resource requirement communication, task progress tracking and delivery support, ensuring that related work is completed safely, compliantly and on time.

2、参与建立、优化并执行运营相关流程、SOP及管理要求，推动工作标准化和规范化，确保符合公司质量体系、EHS及GMP相关要求。

Participate in establishing, optimizing and implementing operation-related processes, SOPs and management requirements, promote work standardization and normalization, and ensure compliance with the company quality system, EHS and applicable GMP requirements.

3、及时识别并反馈运营过程中的异常、偏差和风险，协助开展调查分析，推动纠正预防措施的制定、执行及跟踪关闭。

Timely identify and escalate abnormalities, deviations and risks during operations, assist in investigations and analysis, and drive the development, implementation and closure tracking of corrective and preventive actions.

4、协助开展团队内部工作协调、培训执行、文件记录维护及能力提升相关活动，支持团队运行效率和执行质量的持续提升。

Assist in internal work coordination, training execution, document and record maintenance, and capability improvement activities, supporting continuous improvement of team operating efficiency and execution quality.

5、与质量、生产、工程、仓储、供应链等相关团队保持有效沟通，协助推动问题解决、计划衔接和运营目标达成。

Maintain effective communication with Quality, Production, Engineering, Warehouse, Supply Chain and other relevant teams, and assist in driving issue resolution, plan alignment and achievement of operational objectives.

6、支持内部及外部GMP审计、客户审计和监管检查，协助准备运营相关资料、跟进整改措施并维护相关记录。

Support internal and external GMP audits, client audits and regulatory inspections, assist in preparing operation-related materials, follow up remediation actions and maintain relevant records.

7、定期收集、整理和分析运营相关数据，包括交付、效率、质量、成本及安全指标，形成报告并支持持续改进和问题预防。

Regularly collect, organize and analyze operation-related data, including delivery, efficiency, quality, cost and safety indicators, prepare reports and support continuous improvement and issue prevention.

8、完成上级安排的其他运营支持及质量合规相关工作。

Complete other operation support and quality compliance-related tasks assigned by leadership.

任职要求：

Job Requirements:

1、本科及以上学历，制药工程、化学、生物工程、药学、管理或相关专业。

Bachelor’s degree or above in Pharmaceutical Engineering, Chemistry, Biological Engineering, Pharmacy, Management or related fields.

2、至少5年以上制药、生物医药或相关行业运营、质量或实验室相关工作经验，具有跨部门协作、流程优化或项目支持经验者优先。

At least 5 years of experience in operations, quality or laboratory-related work in the pharmaceutical, biopharmaceutical or related industries; experience in cross-functional collaboration, process optimization or project support is preferred.

3、熟悉制药运营管理、现场管理、偏差/CAPA、变更控制及质量体系要求。

Familiar with pharmaceutical operations management, shopfloor management, deviation/CAPA, change control and quality system requirements.

4、具备良好的计划执行、任务跟进和结果导向意识，能够在质量、效率、成本和交付要求之间进行协调和平衡。

Good planning execution, task follow-up and result-oriented mindset, with the ability to coordinate and balance quality, efficiency, cost and delivery requirements.

5、理解cGMP、数据完整性、EHS及合规管理原则，具备较强的质量意识、风险意识和文件记录规范意识。

Understanding of cGMP, data integrity, EHS and compliance management principles, with strong quality awareness, risk awareness and good documentation practice awareness.

6、具备良好的跨部门沟通协调能力、问题分析与解决能力，以及持续改进/精益管理意识。

Good cross-functional communication and coordination skills, problem analysis and solving capability, and awareness of continuous improvement and lean management.

7、熟练使用Excel、PowerPoint等办公软件进行数据分析、绩效追踪和运营汇报；具备良好的数字化工具应用能力者优先。

Proficient in using office software such as Excel and PowerPoint for data analysis, performance tracking and operational reporting; candidates with good digital tool application skills are preferred.