岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB
负责原材料、半成品、成品检测及环境监测等检测工作。
Be responsible for raw material, semi-finished products testing, finished products testing and environment monitoring program and so on.
支持/负责实验室OOT/OOS结果的调查。
Support/lead the OOT/OOS result investigation

主要职责 / MAIN ACCOUNTABILITIES
1. Routine testing /日常检测
- 负责完成原辅料包材、中间品、产品、环境控制、纯水等的QC检测，并做好结果的趋势分析。
Be responsible for QC test completed in time for raw material, packaging material, semi-product, finish product, environment/PW monitoring and complete trend analysis in time.
- 执行微生物检验，包括菌株传代、接种、培养、鉴定及样品的检测
Perform microbiological testing, including strain passage, inoculation, culture, identification and sample testing。
- 执行理化检验，特别是气相色谱法相关工作当中，完成检验工作。
Perform biochemical test to complete test task, especially for GC and so on.
- 对QC相关文件进行复核，包含但不仅限于原材料检验，半成品检验，成品检验，稳定性检测，日常环境检测等。
Review all QC related document, including but not limited to raw material testing, semi-finished products testing, final goods testing, stability program, routine environment monitoring and so on.
- 支持实验室相关的OOS调查，并支持不合格、偏差及投诉的调查。
Support OOS investigation in Lab and support investigation from NC/AR/complaint.
2. Instrument management /仪器管理
- 支持/负责实验室仪器设备的验证、校验，以及实验室仪器的日常使用及维护。
Support/Be responsible for the validation, calibration, routine usage and maintenance activities of laboratory instruments.
3. Method /方法
- 支持实验室检测方法的确认/验证工作。
Support the validation and verification of laboratory testing methods.
- 支持相关检测方法的培训。
Support the training of relevant testing methods.
4. Material /物料
- 确保试剂、培养基、耗材的安全库存。
Ensure the safety stock for reagent, media and consumables.
5. Others /其他
- 遵守公司以及当地HSE政策、法规。
Comply with Health, Safety & Environment policies and local legal requirements.
- 确保所有操作满足相关质量法规要求。
Make sure all operations meet quality and related regulatory requirements.
- 支持内审及外审工作
Support internal/external audit
- 和其他部门进行沟通合作，确保工作任务的及时完成。
Collaborate with other related departments to make sure the assigned tasks are completed in time.
职位要求：
知识、语言和经验要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE
1.大专及以上学历，生物，化学，医学相关专业或工作经验
Collegue degree (equivalent) or above educational background, majoring in biology, chemistry, medicine or related working experience .
2.语言技能：基本的英语听、说、读、写能力。
Language skills: Basic in Listening, Speaking, Reading and Writing English.
3.熟练的Word Excel等办公软件的操作。
Skilled with Microsoft Word and Excel.
4.熟悉实验室异常结果调查5M1E分析法
Familiar with 5M1E analysis for lab abnormal result investigation.
5.有良好的团队合作能力
Good team cooperation skills.
6.至少有三年微生物检测经验, 拥有理化检测经验者优先。
At least one year of microbiology testing experience. Experience with chemical testing is preferred.
7.熟悉ISO 9001和GMP等相关法规
Be familiar with relative regulations, such as ISO 9001 and GMP.