Chemical Analysis Team will be responsible for all tests except Micro testing The team will be responsible for all the maintenance, calibration, validation and retirement of instruments which used for testing. The team will take the samples based on the requirement. The team will be responsible for all the solutions which used by the team, including volumetric solutions The team will be responsible for all chemical reagents managements, including QC inventory, vendor approval. The team will be responsible for all reference standards management and will be responsible for all columns maintenance and management. The team will be responsible for house keeping of working area The supervisor will be responsible for the release the raw material and intermediates. The supervisor will be responsible for all team member training, qualification and development. Responsible to perform the Lab investigation, OOS and implement the CAPAs as requirement Provide the purchasing order of shortage items to support team weekly. 化学分析组将负责微生物检测之外的所有检测。 该团队负责检测仪器的维护,校验,验证和退役。 该团队按照要求进行取样。 该团队负责制备所有该团队使用的溶剂,包括滴定液。 该团队负责所有化学试剂的管理,包括QC试剂库存及试剂供应商审批。该团队负责所有对照品的管理以及负责所有色谱柱的维护和管理。 该团队负责工作区域的卫生。 团队主管负责放行原料和中间体。 团队主管负责所有团队成员的培训,授权和发展。 负责开展实验室调查,OOS调查,以及执行所要求的CAPA。 每周向支持团队提交短缺物品的采购订单。
WHO YOU ARE
Bachelor or above in chemistry/pharmacy or other related areas More than 2 years working experiences in drug production and quality management actual experience. Excellent leadership and communication skills esp. the ability to work with local and global cross functional teams Fluentin Mandarin (orally and writing), good communication skills in English (oral and writing) 化学及药学相关专业本科以上学历。 二年以上药品生产工作经验,具有实际的QC工作经验。 杰出的领导才能和沟通能力,尤其能够进行本地和全球的跨职能团队合作。 流利的中文表达能力(口头和写作),良好的英语沟通能力(口头和写作)。