职位描述
协助QC 经理建立化学实验室并维护实验室的日常运行
Assist QC Manager to establish the new chem. lab and maintain the routine operation of chem. Lab
起草，复核或更新相关的SOP，检验方法和质量标准
Prepare, review and updated related SOPs, test method and specifications
起草仪器的确认方案，实施仪器的确认试验并完成确认报告，例如化学实验室仪器的安装/运行/性能确认和再确认
Prepare the qualification protocol, conduct the qualification activities for equipments and complete the qualification report, such as IQ/OQ/PQ or re-qualification for chem. Lab equipment.
参与技术转移工作，实施分析方法转移并完成分析方法转移报告
Participate the technical transferring ，conduct the analytical method transferring work and complete the analytical method transferring report
起草分析方法验证/确认方案，实施相关测试，完成验证/确认报告，例如工艺验证，清洁验证，药典方法确认等
Prepare the analytical method validation/verification protocol, conduct the related testing and finish the validation report, such as process validation, cleaning validation, pharmacopeia test method verification etc.
作为实验室计算机系统的本地管理员，清洁，维护试验仪器，联系供应商或合适的承包商完成仪器的确认或校验，以确保仪器设备处于良好状态
As local administrator of laboratory computerized system, Clean， maintain the equipments and contact with supplier or proper contractor to qualify/calibrate the equipments to keep in good status.
作为试剂管理员和对照品管理员协助化学实验室耗材管理，包括试剂，对照品，玻璃仪器，个人防护用品等
Assist in As administrator of reagent and reference standard, management of chemical lab consumables, including reagents, reference standards, glassware, PPE etc..
复核检验记录，必要时协助OOS 调查
Perform analytical record double checking and assist in OOS investigations when necessary.
起草新员工的培训方案和确认计划并实施培训
Prepare the new staff training plan and qualification plan for new staff and conduct the training.
协助SHE 管理，确保试验室各项活动符合公司SHE 的政策
Assist in SHE management to keep the lab to be in conformity with company SHE policy.
完成其他指定工作
Complete other assigned tasks
GMP 符合性
GMP compliance
严格执行化学室的相关标准作业程序和规章制度
Follow related SOPs and regulations strictly in chemical lab.
及时按照SOP 的要求填写相关文件记录如批化验记录、仪器使用和维护记录等并保证内容的准确性
Fill in related documentation such as BAR, other logbook etc., timely to ensure the accuracy of content as per requirement of SOPs.
积极参加对自检中所发现缺陷的整改
Take part in actively in correction to the observations found in self-inspection.
胜任能力COMPETENCIES
基本的分析化学知识；设定高目标并通过持续改进专业技能扮演国际化的角色；接受持续的培训去开拓新的分析领域
Have basic analytical chemistry knowledge and set high goal to improve professional skills to meet the requirement as ainternational role; receive continuous training to explore new analytical areas.
客户第一
Customer focus
任何行动都基于满足内外客户的基本需求；发展并维持高效的客户关系
Make both internal and external customers and their needs a primary focus of one’s actions; develop and sustain productive customer relationships.
团队精神
Team work
展现出强烈的意愿同来自部门内部同事或外部同事为了共同的目标而紧密工作的精神
Show strong willingness to work closely with peers within own unit or colleagues from other unitstoward a common goal.
结果为导向
Result oriented
为组织的成功和个人的贡献建立挑战性的目标；努力实现或超越目标
Establish stretched goals for organization successand personal accomplishments; strive to meet or exceed those goals.
学习和适应能力
Learning /adaptability
