$ads={1}
参考: 37025
地点: Huizhou - Daiya Bay, Guangdong, China
科莱恩是一家专注、创新的特种化学品公司，总部位于瑞士巴塞尔附近。
2018财政年实现66亿瑞士法郎的销售额；有近14000名员工分布在全球50个国家提供服务。
科莱恩的业务领域专注于长远发展，并集中于4个业务方向：护理化学品、催化剂、自然资源以及塑料与涂料。
我们相信， 我们的成功是基于客户的成功； 所以在创新能力和激励人心上的投资，能让我们变得更富激情和有决断力，从而帮助我们实现目标。
加入我们，一起在通过化学在全球创造可持续发展的价值！
岗位描述:
Essential Function 1: Lab GMP quality system
1 Lab GMP practice: establish and maintain the good testing practice in lab, to be compliance with GMP requirement.
实验室规范：建立和维护实验室良好的工作规范，符合药品检验的法规要求。
2 GMP documents management - Responsible for drafting of GMP guide line / work instruction / sop for QC lab and GMP documents distribution and recovery
GMP 文件管理 - 起草实验室GMP相关工作规程及操作指引，并负责发放和回收。
3 GMP audit - Responsible for GMP audit follow up to make sure that all finds have been closed and pass GMP audit.
GMP审核 - 负责跟进实验室所有的GMP相关的审核发现项，以确保通过GMP审核。
Essential Function 2: GMP QC related work
1 QC daily management - Responsible for GMP product and raw material testing /releasing arrangement and keep all test records match GMP requirement.
负责GMP相关产品及原材料的检测及放行,保证所有的产品记录满足GMP相关要求。
2 Methods management - Responsible for GMP methods set up and prepare validation protocol, review and collect all documents of GMP test methods validation.
负责GMP相关的检测方法的建立及准备验证方案，评审及收集所有的GMP检测方法的验证文件。
3 Instruments management - including GMP related equipment validation , calibration, 5S maintenance, labels/regular internal/external calibration reports / WI for Instruments and calibration / File for Instrument update.
管理包括GMP 相关仪器验证、校正、5S维护、标签更新和定期更新内外校验报告、仪器文件夹、仪器操作规程和内校规程。
4 Preparation of standard solution and buffer solution and regular review to ensure right concentration data for batch test calculation.
准备标准溶液及缓冲液的配制及管理- 定期对溶液进行审查，以确保溶液的浓度正确、在有效期内、标识合格、安全库存OK。
5 Sample management - Ensure all GMP standard samples and retained samples for batches of RM/ IPC / FG are
stored/recorded properly according to regulation and easy to be available for traceability once needed.
根据相关的规定对GMP样品进行管理，以确保所有的原材料、中控产品、成品的标准样及留样能得到合理地保存和记录，以便于日后追溯。
Essential Function 3: management of OOS and deviation investigation
1 OOS management - Responsible for all OOS investigation actives for lab and prepare investigation report for GMP product.
负责实验室GMP产品不合格调查并准备最终的调查报告。
2 Aging/Aged stock review / reinspection - Regular Inspection/review of the non-conforming and aging stock of GMP goods, raw material and blocked stock。.
快要过期的/已过期的库存的审查和复检 - 定期对不合格的和快要过期的GMP产品库存、及相关原材料库存以及冻结库存进行检验和审查。
3 Deviation management- Leader of deviation investigation for lab, assist to GMP QA manager for deviation management
偏差管理 - 实验室偏差调查负责人，并协助GMP质量经理对偏差进行管理。
4 Change control- Leader of change control for lab, assist to GMP QA manager for action plan
变更控制 - 实验室变更控制负责人，并协助GMP质量经理对变更行动计划的管理。
Essential Function 4: EHS / 5S
1 Compliance with company all ESHA regulations
符合公司所有的安全规定
2 5S maintenance in lab to ensure high hygiene/ESHA level with continuous improvement.
5S和ESHA的维护 - 对实验室进行5S维护，以确保良好的卫生和ESHA水平。
岗位要求:
Education:
Bachelor degree or above, major in biology, medicine or chemist
Business experience:
a) More than 3 years working experience in pharmaceutical company lab.
b) Know well of China GMP and US FDA requirement and have rich lab GMP audit experience.
c) Know well of lab precision equipment and computer validation system, like as HPLC /GPC/GC system .
d) Excellent organizational skills, communication skills, planning ability
e) Good computer skills and data processing capabilities
f) Good English speaking and writing skill
