西安招聘

职位描述：
任务和职责：
Role and Responsibilities:


1. 作为伤口护理相关产品负责人对上海强生和强生（中国）有限公司生产的，及在中国市场销售的创可贴提供质量指导及服务。
As relative Product/Process owner, provide Quality Assurance support /service to relevant Bandage products manufactured in Johnson & Johnson (China) Consumer Group, and will be launched and sale in China.

2. 作为下列产品/工艺的负责人
As Product/Process owner of:
2.1. 创可贴类产品 Bandages product
苯扎氯铵类创可贴 BABAB Benzalkonium Chloride Patches
配液/涂布/层压/分切/打孔/复卷 Mixing/Coating/Lamination/Slitting/Perforation/Spooling
创可贴成型/环氧乙烷消毒 Finishing/ETO sterilization

负责对上述产品, 工艺进行批记录核对和产品放行批准，工艺监督, 根据需要进行稳定性考察及年度产品回顾。处理针对上述产品的消费者投诉，包括原因调查，制订相关整改预防措施并监督其落实执行，文件归档直至最后结案。并且负责每月关键绩效指标的汇总和报告。
Be responsible for routine batch sheet review and product release, process monitor. Conduct stability testing and Annual Product Review for product assigned as necessary. Be responsible for consumer complaints handling of products owned, include root cause investigation, develop corrective /preventive action plan and ensure their implementations, documents filing till final case closure. Also be responsible for monthly KPI summary and reporting.

3. 负责出口邦廸创可贴产品图文标准的审核、批准，确保使用的标准符合公司及相关标准的要求。
Approve CG spec for exporting Band Aid products to ensure the specs in compliance with company requirement and related standards.

4. 协同其他相关部门一起完成相关项目的实施,TGA审计和药品GMP认证的维护。
Work with other Functions in relevant project and initiatives, TGA audit/Drug GMP re-certificate etc.

5. 参与业务持续发展/成本改进/技术转移/出口产品项目的质量活动，负责验证相关文件的审核并监督实施情况，负责审核验证方案和报告。
Provide QA expertise in BCP/CIP/TT/exporting product project, be responsible for validation document review and validation execution monitoring. Provide training for Operation Quality Inspector for product/process assigned.

6. 协助相关产品/工艺的成本优化及工艺改进。
Support process improvement/optimization and cost improvement projects for the products/processes assigned.

7. 协助亚太区技术部进行产品更新和改进，以进一步满足消费者要求。
Provide QA support to Regional TA franchise in developing new/improved products that would answer consumer needs in accordance with agreed upon directions.

8. 负责提供相关产品在不符合项，消费者投诉中发现的一些重要质量问题的质量保证支持。
Provide QA support in troubleshooting major quality problems（non-conformance, consumer complaint）of products assigned.

9. 根据强生总部的政策、良好生产管理规范的指导方针，以及适用的质量法规要求制订并更新质量保证程序文件和相应的标准操作规程。
Initiate, review and update as appropriate the Quality System Procedures (QSP) and relevant SOP in compliance to Q&Cww policies, cGMP and regulatory requirements.

10. 支持质量体系管理小组的内部审计工作, 保证质量体系在生产过程中的完好执行。
To support Quality Compliance to do internal audits to ensure appropriate quality system is practice well in production.

11. 支持ISO13485/EN46002，GMP要求在伤口护理产品的生产区域的生产活动的执行，确保其符合ISO13485/EN46002, GMP的要求.。
Support ISO13485/EN46002, GMP requirement implementation to ensure that all operation activities in wound care production areas are in conformity to ISO13485/EN46002, GMP standards.

12. 负责邦迪产品的假货鉴别
Be responsible for Bandages product counterfeit identification.


？ 人员管理和发展
People Management and Development

1. 结合自身工作内容和发展需要提出相关培训需求。根据培训计划，按时完成指定培训。
Raise training request according to position and development. Complete assigned training based on training plan.
2. 负责制定下属的培训计划，并提供必要的辅导，确保下属按计划完成相应的培训以达到适合其岗位的技能。
Responsible for subordinates’ training plan and provide appropriate coaching, to ensure subordinates complete related trainings within schedule and qualified for the position.

？ 其他职责
Other Responsibility

1. 负责管理区域工作安全。
Be responsible for safe working practices in own area.

2. 完成其他指派任务。
Fulfill other tasks assigned.


任职资格：
Key Competency/Skills:

1 熟悉医疗器械及药品相关的国内国际质量体系及法规要求。
Good understanding of regulatory and other international requirements on drug and medical device.

2 相关经验及教育背景：
Relevant experience and education background:

2.1 至少5年以上从事药品或医疗器械制造业质量保证或质量合规的相关工作经验。
At least has 5 years experience in Quality Assurance, Quality Compliance or relevant area in Pharmaceutical, MD or OTC manufacturers.
2.2 化学、医药或相关专业，本科或以上学历。
Bachelor degree or above preferred on Chemistry, Pharmacy or other relevant science.

3 其他技能：
The other skills:

3.1 具备良好的团队合作及沟通技能，能够处理及协调复杂事件。
Good inter-personal and communication skill, team player with dynamic proactive work style and complexity handling.
3.2 具备较强的产品、工艺确认或验证生命周期的技术背景
Solid validation life cycle knowledge and technical background on product/process validation
3.3 英文流利，说写自如
Fluent English in both writing and speaking.
3.4 熟练操作各办公应用软件
Good knowledge of Office Software
3.5 工作汇报技巧娴熟
Good presentation skills 举报 分享

拥有125年历史的美国强生公司是世界上最具综合性、业务分布范围最广泛的健康护理产品的制造和服务企业，为消费品、制药以及医疗器材和诊断产品市场提供全面的产品和服务。强生公司连续多年名列《财富》“全球最受尊敬的公司”排行榜前列。
 
强生公司一致注重在中国的发展，强生（中国）有限公司1992年在上海市闵行经济技术开发区成立，是强生公司在中国大陆设立的首家独资企业，致力于生产和推广高品质的适合各种年龄段的个人卫生护理用品，推动中国家庭健康护理水平的提高，公司的产品不仅供应国内消费品市场，而且还出口供应国际市场。强生（中国）有限公司的使命是成为中国最受信赖的消费类健康保健公司。公司致力于生产和销售高品质的个人保健产品，以增进中国家庭的健康。
 
With more than 100 years of history, Johnson & Johnson (JNJ) is the world’s most broadly based healthcare company discovering, developing, and manufacturing consumer health, pharmaceuticals, and medical devices and diagnostics products. With over 250 operating companies, Johnson & Johnson has approximately 114,000 employees in 57 countries and markets its products throughout the world. It has been ranked among the top of the global Most Admired Companies by Fortune for years.
Johnson & Johnson has been committed to its development in China. Established in Shanghai Minhang Economic & Technological Development Zone in January 1992, Johnson & Johnson China Ltd. is the first wholly-funded enterprise set up by Johnson & Johnson. It is committed to producing and promoting high quality personal health care products catering for consumers of various ages, and driving the health care of Chinese families. Its products are not only sold in domestic consumer market, but also exported to international markets. The mission of Johnson & Johnson China Ltd. is to become the most reliable consumer health care product provider in China. It is committed to producing and selling high quality health care products to enhance the health of Chinese families.
 
更多机会请登陆www.careers.jnj.com

强生消费品中国今年启动了校招微博，我们将在第一时间公布校招信息和校招进程，请@强生消费品中国-校园招聘。