杭州招聘

职位描述：
本职位负责质量管理体系的运行和维护，确保其符合国内外法规要求（FDA, 加拿大，欧盟等法规和AMO总部文件），并确保质量体系在工厂内有效得到贯彻，维护和改进。
This position is responsible for maintaining and implementing the quality system, to ensure the quality system complying with external regulatory requirement and AMO requirements (FDA, Canada and EU etc related regulatory and AMO Documents), and to ensure Quality System to be effectively implemented, maintained, improved throughout the plant.
主要职责包括：国内外法规符合性，质量回顾会议准备与跟踪，质量审计准备与发现项跟踪，LMS ComplianceWire项目，工厂质量培训计划等。
The main responsibilities include system compliance regarding external regulation, preparation of periodically review meeting, preparation of quality audit and follow-up of observations, LMS ComplianceWire project, Quality training of plant.
 

主要职责: ESSENTIAL DUTIES AND RESPONSIBILITIES: 权重% of time or importance
质量体系的维护和推行: Quality System Maintain and Implementation
1. 收集更新外部法规要求如FDA QSR 820, GMP标准和加拿大，欧盟GMP等。
Collect and Update the external regulatory, eg. FDA QSR 820, GMP and Canada, EU GMP etc.
2. 按照外部法规要求维护和改进质量体系以保证符合要求。
Maintain and improve quality system to meet compliance with external regulatory.
3. 收集内部和中国法规要求：如中国药品法规、中国医疗器械法规、中国卫生系统法规，和总部法规要求等。
Collection of internal and regulation requirements in China: Such as China's drug regulation, medical device Regulation, Hygiene system regulations, and the headquarters of regulatory requirements etc.
4. 按照内部和中国法规要维护和改进质量体系以保证符合要求。
In accordance with the internal and Chinese regulations to maintain and improve the quality system to ensure compliance.
5. 按照中国法规机构要求及时通过相应信息：如申报、备案等。
In accordance with the requirements of regulatory agencies in China, pass appropriate regulations requirements: such as information submit regulation authorities and so on.
6. 准备并现场支持月度、季度质量会议和管理评审，小结并跟踪质量会议和管理评审的输出及实施。
Prepare and support periodically quality meeting including monthly & quarterly quality council, and quarterly management review, summarize the output of the meeting and tracking the implementation of relevant action plan.
7. 更新工厂质量手册和工厂主文件
Revise quality manual and site master file. 40%
质量审计准备和发现项跟踪:
Support quality audit and follow the closure of observations.
1. 支持所有法规检查和内部审计的准备行动。参与各部门准备和接待法规审计、集团AQR检查与审计和内部审计。
Support the preparation of regulatory audit and internal audit; facilitate the preparation of each department for regulatory inspection, AQR inspection and internal audit.
2. 现场支持法规审计以及集团AQR检查与审计。
Support on-site regulatory inspection and AQR inspection.
3. 跟踪审计发现项（含near miss）的及时回应和相关行动计划的按时完成。
Tracking the on-time delivery of response to the observations and follow the implementation of associated action plan. 30%
LMS ComplianceWire项目: LMS ComplianceWire project
1. 作为LMS ComplianceWire项目领导者，参与总部组织的项目会议。
Participated in the LMS ComplianceWire project as the project leader of the site.
2. 制定行动计划，协调工厂各部门以在杭州工厂启动该系统。
Establish the action plan and coordinate relevant departments to launch LMS ComplianceWire in AMO Hangzhou site.
3. 组织LMS ComplianceWire的工厂培训。
Offer the system training of LMS ComplianceWire to AMO Hangzhou site before launching. 10%
工厂质量培训计划: Plant quality training plan
1. 更新工厂程序培训需求并制定工厂年度质量培训计划。
Update training matrix of site procedure and prepare plant quality training plan of the year.
2. 执行工厂年度质量培训计划，并跟踪各部门培训计划完成情况。
Implementing the plant quality training plan as scheduled and tracking the completion of training plan for each department of site.
3. 按月检查雅培和AMO总部程序的更新情况，并更新对应培训需求。
Check the revision of procedure in Abbott and AMO on the monthly basis and update the training matrix accordingly. 5%
其他: Others:
1. 遵循ISO 14001 及EHS的要求。
Follow ISO 14001 and EHS requirements
2. 主管安排的其它任务。
Support other additional working assigned by Supervisor 15%
学历和经验EDUCATION AND EXPERIENCE
1. 药学、化学或相关专业本科学历。
Bachelor degree, major in pharmaceutical or chemistry or other related discipline.
2. 两年以上制药或医疗器械行业质量部门工作经验, 具制药/医疗器械行业质量保证工作经验者佳。
A minimum of two years work experience in quality department in pharmaceutical/medical device industry, experience of quality assurance will be preferred.

必备技能: ESSENTIAL SKILLS:
1. 熟悉质量管理体系；熟悉质量管理工具的应用。
Familiar with quality management system, and the quality tools implementation.
2. 熟悉相关国家和地方质量政策法规（GMP，ISO， 药监局，药检所等)
Familiar with relevant National and local quality regulation.( GMP, ISO, cFDA, IDC)
3. 电脑及业务软件的使用能力
Familiar with the Office software and other professional software.
4. 英语水平较好(会话、阅读相当于6级)
English level CET- 6 for oral and reading.

能力要求ABILITIES:
1. 熟悉质量系统
Knowledge of quality system
2. 仔细和认真，责任心强
Work hard and earnest.
3. 愿意在高压力下工作,自我激励
Willing to work under pressure, self-starting and self-inspiring
4. 良好的协调能力
Good coordinate ability.
5. 英语读写能力强。
Perfect reading and writing skill in English.
6. 良好的计算机使用技巧
Good computer skills.
7. 熟悉基本办公软件的使用。
Knowledge of Microsoft Word, Excel. 举报 分享

雅培眼力健 世界护眼专家

雅培眼力健（杭州）制药有限公司

雅培眼力健为美国医药巨头雅培公司的医疗光学事业部，是一家从事专业化医疗保健及护眼产品研发、生产和销售的国际性公司，在护眼产品及眼科医疗手术器械方面都具有世界领先地位。雅培公司总部设在美国芝加哥，眼力健美国公司位于加州圣安娜市，其子公司、分部及代理商遍布世界各地。

占地七万余平米的雅培眼力健(杭州)制药有限公司，是雅培眼力健独家投资近三千万美元建造的生产护眼系列产品的公司。公司产品大部分出口到日本、美国、欧洲及亚太其他国家和地区。公司的产品以其特有的品质倍受中高收入群体的青睐，其中全能品牌作为总公司隐形眼镜护理液的主打品牌，全球年销售额呈不断攀升的势头。为满足日益增长的全球市场需求,公司规模不断扩大,生产能力不断提高，现特此诚征专业技术及管理英才。

公司将为您提供具有竞争力的薪酬水平,完善的养老保险、失业保险、工伤保险；住房公积金制度；医疗保障制度 （高比例报销医疗费、住院保险、子女医药费部分报销制度）；意外伤害保险和寿险； 年度薪资增长计划；带薪休假制度；跟绩效管理体系相挂钩的奖金制度;晋升制度和内部应聘转岗制度;长期贡献奖;完整的培训体系

有意者在一周内请将中英文简历、身份证及学历证书复印件寄至：杭州经济技术开发区4号200号大街雅培眼力健（杭州）制药有限公司人力资源部收，邮编310018，或E-Mail: hz_recruit@amo.abbott.com，合则约见，谢绝来电来访。