锦鲤求职岗位描述
具备以下能力： Possess the following capability：
1、熟悉QC特定领域技术的理论知识和实际工作经验，如产品检测、微生物、仪器管理等；
Familiar with the theoretical knowledge and practical experience in specific QC technical areas, such as product testing, microbiology, and instrument management;
2、熟悉并坚守GMP和数据完整性要求；
Familiar with and committed to GMP and data integrity requirements;
3、较强的书面和口头沟通能力以及出色的人际交往能力。
Strong communication skills, both written and verbal, and outstanding interpersonal skills.
4、优秀的英文沟通能力。
Proficient English communication skills.
5、可以熟练地阅读、撰写并理解英文文档。
Be skilled at reading, writing and understanding of English documentation.
6、良好的计算机操作技能，熟练使用Word、Excel、PowerPoint等。
Good computer operation skill, intermediate level in Microsoft Word, Excel, PowerPoint etc.
7、经过培训或具有满足NMPA、EMA和FDA等GMP法规要求的相关经验。
Must be trained or have experience to meet the GMP regulations of NMPA, EMA and FDA, etc.
8、批判性思维、科学推理和解决问题的能力。
Critical thinking, scientific reasoning and problem solving skills.
工作职责 Job Responsibility
1、支持QC部门客户审计工作，如审计材料的准备、全程的审计参与、部门介绍、推动审计发现项的回复及整改；
Support QC customer audits, including preparation of audit materials, full participation in audits, department introduction, and follow-up on responses and remediation actions for audit findings;
2、负责QC部门审计、质量KPI的数据监控，及时发现并支持不良趋势并助力改进和质量提升；
Monitor QC audit performance and quality KPI data, identify adverse trends in a timely manner, and support continuous improvement and quality enhancement;
3、协助检测团队进行异常数据及OOT数据识别，就业务团队工作中遇到的问题给予处理意见，担任QC与QA沟通的桥梁，保证质量部门信息的沟通与一致意见的达成；
Assist testing teams in identifying abnormal data and OOT results, provide handling recommendations for issues encountered by business teams, act as a communication bridge between QC and QA, and ensure alignment and consistent understanding within the quality organization;
4、负责QC部门实验室事件的周期性回顾，包括月度和季度回顾，并生成季度报告；
Be responsible for periodic review of QC laboratory events, including monthly and quarterly reviews, and prepare quarterly reports;
5、组织合规文件建设和培训活动，如质量合规活动、合规主题分享、合规知识竞赛；
Organize compliance document development and training activities, such as quality compliance campaigns, compliance topic sharing sessions, and compliance knowledge competitions;
6、协助实验室Gemba以及数据完整性相关检查；
Assist in laboratory Gemba activities and data integrity-related inspections;
7、支持QC部门质量体系相关工作的推进，包括偏差、实验室调查、变更、CAPA及程序文件等事项的跟进与协调，确保相关工作按计划完成；
Support the advancement of QC quality system activities, including follow-up and coordination of deviations, laboratory investigations, changes, CAPAs, and procedural documents, to ensure timely completion of related tasks;
8、跟踪法规、客户及公司质量要求的更新，评估对QC实验室合规工作的影响，并推动相关要求在部门内的宣贯和落实；
Track updates to regulatory, customer, and company quality requirements, assess their impact on QC laboratory compliance, and drive communication and implementation of related requirements within the department;
9、主管其他指派的工作（如有）。
Any other duties assigned by the supervisor, if applicable.