QS Specialist

About Animal Health in China

As the leading animal health company in China, we have extensive business coverage from the full value chain in R&D, production to sales and a diversified product portfolio covering swine, poultry, pets, cattle vaccines and medicines. We are always "in China and for China". We've pioneered many game-changers in the veterinary medicine, and we're looking to our customers' needs to guide us into the future.

Job Responsibilities:

1. As the training MSO, Responsible for training management work, including site training plan initiation, training matrix review, certification review, training coordinator management as well as follow up the training system status and evaluate the system.

作为培训的MSO，负责培训管理，包括工厂培训计划的制定，培训矩阵和上岗证的审核，培训协调员的管理、培训体系状态的追踪和回顾及培训档案的归档等。

2. As system administrator to support IDEA for CON and LOS system.

作为系统管理员支持IDEA for CON、LOS系统的权限管理。

3. As the document management MSO, Responsible for document system management work, including system management, GDP, document distribution and retrieve, achievement, and archive room etc.

作为文件体系MSO，负责文件体系管理，包括文件管理流程、记录填写要求、文件分发及回收、文件归档以及档案室管理等。

4. As the supplier management MSO, Responsible for supplier management, including supplier qualification, supplier files, quality agreements, regular reviews of materials and suppliers, and the operation of Go track and GBS systems, etc.

作为供应商管理的MSO，负责供应商管理，包括供应商资质确认，供应商档案，质量协议，物料和供应商的定期回顾以及Go track 和GBS系统的操作等

5. Develop and implement consistent processes and systems that assure quality, GMP, and compliance

制定并实施连贯一致的流程和体系以确保质量体系和GMP状态的合规性

6. Participate in the company's internal and external audits to ensure the smooth implementation of internal and external audits

参与公司的内外部审计，确保内外部审计的顺利实施

7. Conduct quality review of GMP documentation that has direct impact on the environment, equipment and facilities;

负责从质量的角度对直接影响环境、设备和设施的GMP文件进行审核

8. Performs all Company business in accordance with all regulations(e.g., EEO, FDA, etc.) and Company policy and procedures, when violations are noted/observed they are to be immediately reported to management. Demonstrated high ethical and professional standards with all business contacts in order to maintain BIAHOC's excellent reputation in the community.

依照所有相关法规、公司政策和规程进行日常操作，当发现侵害公司利益事项时请立即上报管理层。与业务伙伴接触时应体现专业素养和高度的道德标准，以保证BI泰州工厂在业内的良好声誉

9. Investigation of Quality issues

参与质量问题的调查

10. Fully acknowledged that the criticalness of fulfilling the quality commitment, with respect to the daily implementation of quality commitment. Report quality discrepancy in timely manner and pursuing right first-time target.

充分了解质量承诺兑现的重要性，在日常实践中履行质量承诺，及时汇报质量事件并追求一次做对的目标。

Job Requirements:

1. Minimum of a bachelor degree with at least 3 years of experience in a GMP regulated environment, have a group leading experience is preferred.

本科以上学历，3年以上GMP行业工作经验，具备团队管理经验者优先

2. Having strong knowledge and experience about change control, deviation, CAPA, OOS

对变更、偏差、CAPA以及OOS有丰富的知识和经验

3. Having strong knowledge and experience about supplier management

对供应商管理有丰富的知识和经验

4. Having project experience is preferred

具有项目管理经验者优先

5. Good English skill is preferred.

具有良好英语能力者优先

6. Good written communication skills, including attention to detail

良好的书写及沟通技能，包括SOP、标准及其他文件的规定

7. Good organization skills and Ability to handle multiple tasks

良好的组织能力,能够胜任多重任务

8. Ability to perform extremely detailed activities and to perform basic mathematical calculations

能够从事及其细致的工作,能够进行基础的精确计算

9. Ability to utilize software programs, such as Microsoft word, excel etc.

能够操作集成软件系统，如：微软word，excel等

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.