上海招聘

The Validation Specialist role is a laboratory-based position belonging to the China Validation Services Laboratory, operating under the guidance of the Senior Validation Specialist and reporting directly to the Lab Manager. The position’s main responsibilities include:
验证专家角色是属于中国验证服务实验室的实验室职位，在高级验证专家的指导下运作，并直接向实验室经理报告。该职位的主要职责包括：
For employee working in Micro lab:
对于在微实验室工作的员工：
Executing microbial tests according to approved test protocols and SOPs, especially preliminary studies and standard/noncomplex Bacterial Retention Tests.
Demonstrating superior ability in using aseptic technique to perform laboratory work that requires a sterile environment.
Generating complete documentation of results and accurate data during testing according to Good Documentation Practices and ALCOA+ principles.
Scheduling, preparing and obtaining necessary equipment, supplies, and filters to conduct testing in a timely fashion.
Consulting a Senior Validation Specialist, Validation Scientist, Lab Manager or a Validation Project Manager (VPM) to obtain all required clarification and/or technical guidelines when necessary, allowing to develop knowledge and skills.
The traceability of customer product samples according to the current process and approved SOPs.
The handling of customer product samples in accordance with all safety rules (PPE, MSDS and EHS recommendations to be considered before to handle the products).
Reporting all aberrant, unexpected results or deviation to the Senior Validation Specialist, Validation Scientist, Lab Process Coordinator or Lab Manager as soon as possible to ensure efficient trouble shooting with QA oversight.
Keeping test equipment, storage areas and workspace clean and tidy.
Contribute to the culture of Safety and Quality by ensuring that all laboratory operations are performed according to the Safety and Quality procedures in place.
Driving continuous process improvement by making recommendations for workspace, equipment, and processes.
Remaining current with the learning plan, all training modules and maintaining accurate documentation of all records.
Report all accidents, unsafe conditions, incidents or near misses to the EHS Relay or the Lab Manager.
Creation, update and periodic review of operational SOPs
根据批准的测试协议和SOP执行微生物测试，特别是初步研究和标准/非复杂细菌保留测试。
展示使用无菌技术进行需要无菌环境的实验室工作的卓越能力。
在测试过程中，根据良好文档规范和 ALCOA+ 原则生成完整的结果文档和准确数据。
安排，准备和获得必要的设备，用品和过滤器，以便及时进行测试。
咨询高级验证专家，验证科学家，实验室经理或验证项目经理（VPM），以便在必要时获得所有必需的澄清和/或技术指南，从而发展知识和技能。
根据当前流程和批准的SOP对客户产品样品进行可追溯性。
根据所有安全规则处理客户产品样品（PPE，MSDS和EHS建议在处理产品之前要考虑）。
尽快向高级验证专家，验证科学家，实验室流程协调员或实验室经理报告所有异常，意外结果或偏差，以确保通过QA监督进行有效的故障排除。
保持测试设备、存储区域和工作空间的干净整洁。
通过确保所有实验室操作都按照现有的安全和质量程序进行，为安全和质量文化做出贡献。
通过为工作空间，设备和流程提出建议来推动持续的流程改进。
保持学习计划，所有培训模块的最新状态，并保持所有记录的准确记录。
向 EHS 继电器或实验室经理报告所有事故、不安全条件、事故或未遂事故。
制定、更新和定期审查业务标准规划
Additional Responsibilities其他职责
For employee working in Micro lab:
Drafting bacterial retention test protocols and reports according to the process parameters provided by the customer in the request questionnaire and considering the preliminary studies results.
Executing complex bacterial retention test according to approved test protocols and SOPs, under the guidance of the Senior Validation Specialist or Validation Scientist when applicable.
Conducting bacteria identification when applicable using the current id system in place and according to the adequate SOP.
对于在微实验室工作的员工：
根据客户在请求问卷中提供的工艺参数，并考虑初步研究结果，起草细菌保留测试方案和报告。
根据批准的测试方案和SOP执行复杂的细菌保留测试，在适用时在高级验证专家或验证科学家的指导下。
在适用时使用当前的ID系统并根据适当的SOP进行细菌识别。
For employee working in either PT or Micro lab:
Receiving customer samples in the lab according to the lab SOPs, as backup for the Lab Assistant.
Preparing B. diminuta culture as scheduled each week, including extra work during the week-end when needed.
Conducting water monitoring control, according to the schedule defined.
Conducting environment monitoring control, according to the schedule defined.
Responsible for initiating a TrackWise deviation is any non-conformity is detected
Leading or participating to equipment or test method qualification.
Conducting / handling the maintenance and/or calibration for equipment
Ordering / Controlling lab consumables
Equipment and Lab cleaning
Execution of the tests on customer site.
对于在PT或微实验室工作的员工：
根据实验室SOP在实验室接收客户样品，作为实验室助理的备份。
每周按计划准备B. diminuta培养物，包括在需要时在周末进行额外工作。
根据规定的时间表进行水监测控制。
根据规定的时间表进行环境监测控制。
负责启动 TrackWise 偏差，以防检测到任何不合格
领导或参与设备或测试方法资格。
进行/处理设备的维护和/或校准
订购/控制实验室耗材
设备和实验室清洁
在客户现场执行测试。

苏州猎巨头人力资源有限公司诚聘