QC Manager

2 months ago


Chengdu, China Elanco Full time

Responsibilities:

To manage the whole QC lab, training and assessment on all QC staff; provide coach and instruction to the lab members, control and supervise the operation / analysing process and according to the related regulations, to ensure all the activities of the lab is in line with company standard, policies and HSE. Manage the daily inspection plan to ensure proper task distribution and high performance. 管理实验室,对员工进行培训和考核;指导和带领实验室员工,并根据相应制度, 监督控制实验室运作流程及检验,确保所有的检验活动符合公司标准和制度。实验室日常检验计划管理以确保恰当的任务分配和高绩效。Establish, review or check product quality standard & SOP to ensure all standard in line with related policy . 制定、回顾或审核产品质量标准及SOP,以保证所有标准符合相关的政策。Make sure all the discharged material measuring up to the related standard of GMP and company,record in related document and system, audit analyse records. 根据GMP标准和公司规定,确保被放行的所有物料达到相关标准,并记录在相关文 档及系统中,审核检验记录。Provide lab data review to related person, including product annual review、main raw material analyses data yearly review and monitor data yearly review, stability study etc..为相关人员提供实验室数据回顾,包括产品年度回顾、主要原材料的检验数据 年度回顾,监测数据年度回顾,稳定性试验结果等。Retention samples management, and according to SOP, establish product stability plan and implement and report, carry out related validation. Familiar with analytical method validation.根据SOP组织留样管理,制定产品的稳定性计划、实施并报告,开展相关的验证工作。 熟悉分析方法验证。Review the procedures and testing instructions of raw & packaging materials, intermediates, bulks and finished goods; Check inspection results. 回顾原辅料、包装材料、半成品及成品的检验标准及规程;复核检验结果。To insure the continued success of the 5S. 确保5S在实验室的持续保持。Data integrity management. Ensure QC related data management comply with the regulatory requirements and EGQS through the whole life cycle.数据完整性管理。确保QC相关的数据在整个生命周期内管理符合法规和礼蓝公司制度。Ensure the good management of testing methods and instruments such as appropriate validation/verification/qualification and maintenance.确保分析检测方法、仪器的良好管理,例如恰当的验证、确认、确证和维护。Responsible for other quality relevant requirements according to regulatory requirements and EGQS, such as stability program management, environmental monitoring, reserved sample management, etc.依据法规和礼蓝公司制度,负责达成其他与质量相关的要求,例如稳定性试验的管理、环境监测、留样管理等。Drive operational excellence and process simplification in QC team. 在QC推动运营卓越和流程简化文化。

Requirements:

Education/Experience: Bachelor degree or above, major in the Chemistry or related subjects, at least 2 years working experience in the team management role for the same or related positions. 教育/经验:化学或相关专业本科以上学历,至少2年以上相同或相关职位的团队管理工作经验;Specific knowledge & skills: familiar with GMP, GLP, feed and feed additive, water treatment product and professional in Lab-instrument-handling. 专业知识:熟悉GMP, GLP, 饲料和饲料添加剂,水产产品相关规定,并能专业操作仪器设备;Good teamwork spirit and good skills in communication, interpersonal, problem solving and analysis abilities; 良好的团队合作精神,良好的沟通能力、人际交往能力、分析及解决问题的能力。Familiar with office software and good English skills in reading/writing, basic English communication skills. 熟练掌握办公软件应用,良好的英文读写能力,基本的英文交流能力。

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