生产工艺工程师
雅培眼力健(杭州)制药有限公司
- 公司规模:500-1000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2017-01-11
- 工作地点:杭州
- 招聘人数:若干人
- 学历要求:本科
- 职位月薪:1-1.5万/月
- 职位类别:营运主管
职位描述
职位描述:
负责协调生产运营部进行生产技术相关不符合事件的发起、调查和CAPA措施的制定和实施;追踪运营部不符合调查和CAPA的及时完成以符合杭州工厂设定的目标;负责生产部技术支持工作,包括工艺流程的持续改进项目、生产工艺的标准化、生产过程控制设计、工艺试验及验证活动等;协助生产部对一线员工进行技术培训、人员发展(包括关键岗位的技术考核);协助质量、EHS审计和现场审查。完成主管分配的其他项目任务。
To be responsible for the initiate non-conformances, leading cross functional team to investigate the root cause, and establish CAPA plan to support manufacturing. Coordinating and tracking the investigation and CAPA execution of ERs in operations department to ensure all the CAPA can be closed with high quality and in timely manner. To support manufacturing including, process improvement, manufacturing process standardization, process development and validation activities. To support manufacturing’s talent development in following aspects, provides technical training to operator, operator qualification, and key talent’s technical skill setup. Assist quality and EHS onsite inspection. Complete other project tasks assigned from supervisor.
持续工艺改进:
Process 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. 工艺流程的持续改进项目
Identify process improvement opportunity and leading team to complete the improvement project.
3. 生产工艺的标准化
Support production through leading cross functional team to standardize manufacturing process. % of time or importance
30%
技术支持:
Production technical Support:
4. 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.
5. 协助生产人员上岗证考核和技术员等级考核。
Support manufacturing to conduct operator’s certification and technician grade qualification from technical perspective.
6. 支持或带领由于工艺/设备变更引起的工艺试验及验证活动
Leading or support process validation and development activities as business needs.
7. 对生产员工提供技术培训
Provide technical training to manufacturing operators
8. 协助新产品的工艺开发,验证活动
Support new product transfer process, including process development, validation and associated activities. 40%
法规符合性:
Compliance:
9. 协调生产运营部进行相关不符合事件的发起和调查,追踪纠正预防措施的实施和完成。
Coordinate the initiation, investigation of nonconformance in operation department and follow up the execution of corrective action and preventive action.
10. 协助审计准备、 质量现场审查。
Assist audit preparation and quality onsite inspection. 20%
其他
Others
11. 完成主管指派的其他项目任务。
Complete other project tasks which are assigned by supervisor. 10%
教育背景及工作经验要求
EDUCATION ADN 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 one year related working experience in production or technical support.
一年以上生产或技术支持相关工作经验。
举报
分享
负责协调生产运营部进行生产技术相关不符合事件的发起、调查和CAPA措施的制定和实施;追踪运营部不符合调查和CAPA的及时完成以符合杭州工厂设定的目标;负责生产部技术支持工作,包括工艺流程的持续改进项目、生产工艺的标准化、生产过程控制设计、工艺试验及验证活动等;协助生产部对一线员工进行技术培训、人员发展(包括关键岗位的技术考核);协助质量、EHS审计和现场审查。完成主管分配的其他项目任务。
To be responsible for the initiate non-conformances, leading cross functional team to investigate the root cause, and establish CAPA plan to support manufacturing. Coordinating and tracking the investigation and CAPA execution of ERs in operations department to ensure all the CAPA can be closed with high quality and in timely manner. To support manufacturing including, process improvement, manufacturing process standardization, process development and validation activities. To support manufacturing’s talent development in following aspects, provides technical training to operator, operator qualification, and key talent’s technical skill setup. Assist quality and EHS onsite inspection. Complete other project tasks assigned from supervisor.
持续工艺改进:
Process 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. 工艺流程的持续改进项目
Identify process improvement opportunity and leading team to complete the improvement project.
3. 生产工艺的标准化
Support production through leading cross functional team to standardize manufacturing process. % of time or importance
30%
技术支持:
Production technical Support:
4. 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.
5. 协助生产人员上岗证考核和技术员等级考核。
Support manufacturing to conduct operator’s certification and technician grade qualification from technical perspective.
6. 支持或带领由于工艺/设备变更引起的工艺试验及验证活动
Leading or support process validation and development activities as business needs.
7. 对生产员工提供技术培训
Provide technical training to manufacturing operators
8. 协助新产品的工艺开发,验证活动
Support new product transfer process, including process development, validation and associated activities. 40%
法规符合性:
Compliance:
9. 协调生产运营部进行相关不符合事件的发起和调查,追踪纠正预防措施的实施和完成。
Coordinate the initiation, investigation of nonconformance in operation department and follow up the execution of corrective action and preventive action.
10. 协助审计准备、 质量现场审查。
Assist audit preparation and quality onsite inspection. 20%
其他
Others
11. 完成主管指派的其他项目任务。
Complete other project tasks which are assigned by supervisor. 10%
教育背景及工作经验要求
EDUCATION ADN 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 one year related working experience in production or technical support.
一年以上生产或技术支持相关工作经验。
职能类别: 营运主管
公司介绍
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。
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。
联系方式
- Email:recruit@amo.abbott.com
- 公司地址:上班地址:杭州市经济技术开发区四号大街