QA Specialist-235594
Talent@Boehringer Ingelheim https://www.boehringer-ingelheim.cn/
关于动物保健业务
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作为中国区域动物保健领域的专家，勃林格殷格翰的业务覆盖了从研发、生产到销售的全价值链；产品涵盖猪、家禽、宠物、牛的疫苗和药物等多元领域。勃林格殷格翰秉持“立足中国，服务中国”的理念。在兽医学领域，我们引领创新，开创先河，以客户需求为己任。我们深知，人类的健康与动物的健康休戚相关。加入我们，让我们一同迈向更宽广的未来。工作职责
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.
As system administrator to support IDEA for CON , LOS and Go track system.
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。
作为系统管理员支持IDEA for CON、LOS，Go track系统的权限管理。
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。
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
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
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
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
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
Investigation of Quality issues
参与质量问题的调查
Participate routine meeting and project related meeting
参加日常及项目会议
Maintain a clean and tidy work area whilst complying with quality and EHS requirements. Pay attention to their own safety and the safety of others, no LTA accident.
保持工作区域干净整洁，同时遵守质量和EHS要求。关注自身和他人的安全，无因伤缺勤事故发生。
Fully acknowledged that the criticalness of fulfilling the quality commitment, with respect to the daily implementation of quality commitment that committed with:
Bear in mind that my job is to provide high quality vaccine that protect animal's healthy;
Quality starts from me and my colleagues besides me, we determine the fertility of quality culture;
Follow requirements in SOP and aware of my physical behavior in my working areas;
Record timely and contribute achievement of high rate of right at first time;
Report any product quality related incident timely.
充分了解质量承诺的兑现的重要性，将在日常实践质量承诺的过程中，
时刻意识到我的工作是为保护动物的健康提供高质量的疫苗产品；
质量起步于我和我周围的同事，我们将决定质量文化的生命力；
遵守SOP，关注我在工作区域的行为；
及时记录，努力实现高水平的一次正确合规率；
及时报告产品质量相关的事件。
任职条件：
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，。
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
Having strong knowledge and experience about supplier management
对供应商管理有丰富的知识和经验
Having project experience is preferred
具有项目管理经验者优先
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
Good organization skills
良好的组织能力
Ability to handle multiple tasks
能够胜任多重任务
Ability to perform extremely detailed activities
能够从事及其细致的工作
Ability to perform basic mathematical calculations
能够进行基础的精确计算
Ability to utilize software programs, such as Microsoft word, excel
能够操作集成软件系统，如：微软word，excel
工作 - 质量管理
主要地点 - Africa, Asia, Australasia-中国
组织 - 江苏勃林格殷格翰生物制品有限公司
编制 - 全职
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