杭州招聘

主要工作职责KEY DUTIES AND RESPONSIBILITIES

厂房设施设备验证
1. 公用设施验证Utilities system Validation
当水系统、洁净蒸汽系统、洁净空调系统、压缩空气系统发生变更后, 执行有必要的性能确认
Responsible for performance qualification for water system, clean steam system, HVAC systems, Compressed air system after change happened and when it is necessary.
执行公用系统的定期性能再确认
Perform utility periodic performance requalification
2. 设备验证Equipment qualification
a) 跟踪和监控新购生产设备的安装确认/运行确认。
Track and monitor for IQ/OQ for manufacturing equipment.
b) 负责新购生产设备的性能确认以及设备发生变更后的必要的性能确认
Responsible for performance qualification of new equipment and changes for old equipment if necessary.

灭菌验证
1. 瓶盖塞灭菌验证BTC sterilization validation
a) ETO灭菌工艺年度确认。
Annual qualification for ETO sterilization process
b) GAMMA, E-beam灭菌剂量季度评估，以及按照要求进行剂量分布的确认。
Quarterly assessment for GAMMA and E-Beam sterilization dose, and
dose mapping qualification as required.
c) 组织瓶盖塞微生物负荷的测定。
Organize bioburden testing for BTC.
2. 湿热灭菌工艺验证Steam sterilization process validation
按计划和要求组织湿热灭菌工艺的验证。
Organize steam sterilization process validation according to the schedule.
3. 无菌工艺验证Aseptic process validation
按计划组织无菌工艺的验证。
Organize aseptic process validation according to the schedule.
4. 温湿度分布Temperature and humidity mapping
按计划执行冰箱，培养箱，仓库等的温湿度分布验证。
Organize temperature and humidity mapping for refrigerator, incubator and warehouse etc. according to the schedule.

工艺验证
Process validation
1. 工艺验证前执行必要的工艺研究、开发。
Execute the necessary process study & development activities prior to the process validation.
2. 对现有产品执行产品工艺验证和清洁验证等，包括验证草案起草，组织和协调验证执行，组织或支持验证事件调查，验证数据收集和验证报告起草。
Execute product process validation and cleaning validation, etc. for existing formulations, including validation protocol generation, organize and coordinate validation execution, organize or support the validation event investigation, validation data collection and validation report generation.

原料确认
Raw Material Qualification
1. 支持现有原料的变更，制定原料确认计划。
Support to the change for existing raw material and prepare the raw material qualification plan.
2. 支持原料变更项目的技术风险评估以及识别变更确认所需要的行动
Support performing technical risk assessment on the raw material change project and identify the action plan to qualify the change;
3. 组织原料变更确认活动的执行。
Coordinate and the execution of raw material change qualification activities.

持续工艺改进：
Process continuous improvement:
1. 生产工艺相关的不符合的发起、调查和改进；
Be responsible for the initiation, investigation and corrective action of process related non-conformance.
2. 维护工艺验证的状态及相关工艺文件（验证报告、技术报告及SOP\
WI）。
Maintain the process validation status and related process documents (validation report, technical report and SOP/WI).
3. 工艺流程的持续改进项目
Identify process improvement opportunity and leading team to complete the process improvement project.

技术支持：
Production technical Support:
从技术角度评估生产相关的变更，确保变更对生产工艺不会造成不利影响
Evaluate the changes related to production and provide technical support to ensure the changes will not causes adverse impact to production process.
对生产员工提供技术培训
Provide technical training to manufacturing operators

其他
Others
1. 执行EHS程序并符合要求
Follow EHS procedure and meet the requirement.
2. 遵循ISO 13485, GMP, QS820, 21CFR Part 211和强生政策，符合法规要求。
Follow ISO 13485, GMP, QS820, 21CFR Part 211and Division quality policy, Abbott corporate and meet regulatory compliance.
3. 完成主管指派的其它项目任务
Complete other projects which are assigned by supervisor

学历与经验EDUCATION AND EXPERIENCE
1. Four years college education majored in Biological Science, Chemistry Engineering and Medicine. At least 3 years working experience in Pharmaceutical \ biological \ medical device companies.
大学本科学历，药学、生物、化工等相关专业，生物、制药、医疗器械企业三年以上工作经验 。
2. Well understand the regulation of GMP\ISO13485\ISO9000 quality system.
了解GMP、ISO13485、ISO9000等规范要求。
3. At least three years related working experience in production process or technical support.
三年以上生产技术或技术支持相关工作经验。

必备技能 * ESSENTIAL SKILLS AND ABILITIES *
*员工必备技能应充分考虑质量合规和EHS&S基本要求
*Basic requirements of quality compliance and EHS&S should be taken into full consideration.
1. Good coordination and communication skills and team work.
良好的协调和沟通技巧及团队合作意识。
2. Good problem discovering and solving skill
良好的发现问题，解决问题能力
3. Good words fabricate ability and effective written and oral skills in English
有较强的文字组织能力，良好的英语口语及书写能力

眼力健(杭州)制药有限公司，坐落于下沙杭州经济技术开发区于1995年开始建造，1998年投产运营。是眼力健独家投资三千多万美元建造的生产护眼系列产品的工厂。

目前工厂已经获得了ISO全球23个国家和地区的准入批准，其中包括美国的FDA和加拿大的Health Canada以及中国的GMP。公司拥有行业领先的设备，按照无菌医药产品的标准生产。目前年产量约为5500万瓶。其中齐能品牌系列产品作为总公司隐形眼镜护理液的主打产品，以其特有的品质倍受中高收入群体的青睐。公司大部分产品出口到日本、美国、欧洲及亚太其他国家和地区。

满足不同年龄层客户的需求，是眼力健全体员工的奋斗目标。

我们的产品：隐形眼镜护理液包括全能系列智护系列，双氧水产品和Purite盐溶液，以及滴眼剂。销往国家和地区：产品销往日本、加拿大、美国、中国香港、新加坡、马来西亚、印度尼西亚、韩国、澳大利亚、新西兰、中国等。