锦鲤求职岗位描述
岗位职责 Responsibilities
1. 起草、审核确认/验证方案和报告和相关研究测试方案/报告。
Draft, review validation/verification protocols and reports and associated study test protocols/reports
2. 负责组织和执行厂房设施类、温控类设备、灭菌类系统、洁净通风设备等系统的确认/验证与周期性再确认/验证工作；
Responsible for organizing the qualification/validation and periodic requalification/validation of systems such as factory buildings, temperature control equipment, wet heat sterilization systems, and clean ventilation equipment.
3. 负责组织和执行运输验证相关工作；
Organize and perform transportation validation related work;
4. 审核URS以及设备和仪器的相关评估工作，并参与实施
Review URS and related evaluations of equipment and instruments, and participate in their implementation.
5. 监督和跟踪相关确认/验证方案的执行情况与结果、确保验证工作的有序进行
Supervise and track the implementation and results of relevant qualification/validation protocols, ensuring the orderly progress of validation work.
6. 参与或负责确认的实施、调查处理确认过程中产生的偏离和变更的评估
Participate or be responsible for the evaluation of the implementation of validation, investigation and handling of deviations and changes generated during validation
7. 参与审核设备周期性评估报告
Participate in the review of equipment periodic evaluation reports.
8. 参与审计等相关的质量活动
Participate in quality activities such as audits.
9. 完成上级交办的其它任务
Complete other tasks assigned by superiors.
任职要求 Job Requirements
1. 本科及以上学历，制药工程、化学工程、生物医学工程等相关专业。具备至少3年GMP制药行业验证或工作相关经验，熟悉验证仪器如KAYE\Testo等设备操作；具有现场执行的经验。
Bachelor degree or above, major in pharmaceutical engineering, chemical engineering, biomedical engineering, etc. At least 3 years GMP pharmaceutical industry validation or work-related experience, familiar with the operation of validated instruments such as KAYETesto; experience in on-site execution.
2. 精通FDA、EMA、NMPA、ISPE、ISO等相关GMP法规及指南，熟悉系列中与验证、确认相关的要求。
Proficient in FDA, EMA, NMPA, ISPE, ISO and other relevant GMP regulations and guidelines, familiar with the requirements related to verification and validation in the series.
3. 具备良好的验证类文件编写和审核能力，能够识别潜在合规风险并提出有效改进建议。
Good ability to write and review validation-type documents, identify potential compliance risks and recommend effective improvements
4. 具备优秀的沟通协调能力，能够与内部各部门、客户及官方检查机构进行高效沟通。
Excellent communication and coordination skills, able to effectively communicate with internal departments, clients and regulatory authorities.
5. 具备良好的计算机办公技能和数据分析能力，熟练使用办公软件及文档管理系统。
Good computer office skills and data analysis ability, proficient in using office software and document management systems.
具备良好的英文听说读写能力，能够阅读和翻译英文法规文件及技术资料者优先。
6. Good English listening, speaking, reading and writing skills, able to read and translate English regulatory documents and technical materials is preferred.