主要职责/Key Responsibilities：
1. 负责MQA团队的建设、培训和管理。
Responsible for the construction, training and management of MQA.
2. 全面负责批次记录审核和产品放行流程，包括处理、记录和解决不合格材料和其他质量问题。
Overall responsible for batch records auditing and product release process, including handling, documenting and addressing nonconforming material and other quality issues.
3. 领导或参与调查，以解决和排除操作异常。
Lead or participate in investigations to resolve and troubleshoot operational exceptions.
4. 跟踪、报告不合格情况并进行趋势分析，减少不合格。
Track, trend, report and reduce nonconforming situations.
5. 支持异常报告的解决和批准，并管理所有不合格的已确定的纠正预防措施计划。
Support the resolution and approvals of exception reports and manage the identified corrective and preventive action plans for all nonconformities.
6. 确保验证计划的执行始终符合公司验证政策，并协助维护验证主计划。
Ensure that the validation program is executed consistently in line with Abbott Validation Policies, and assist in the maintenance of the Validation Master Plan.
7. 为所有验证活动提供广泛的质量保证支持基础，包括协调与验证相关培训，
Provide a broad base of Quality Assurance support for all validation activities, including coordination of validation-related training.
8. 根据仪器校准政策的要求，旅行维护和校准活动的质量保证职责。
Perform Quality Assurance roles for maintenance and calibration activities, as required by the Instrument Calibration Policy.
9. 监控对经过验证的系统的合规性，例如厂房/设施/设备确认、过程确认等。 识别、分析和实施解决方案，以应对与合规性相关的过程挑战。
Monitor compliance to validated systems such as Facility/Utilities/Equipment qualifications, process validations, etc. Identify, analyze, and implement solutions to process challenges tied to compliance.
10. 根据需要，管理和保持对 CFR 21第11部分计算机验证要求的合规性。
As required, manage and maintain compliance to CFR 21 Part 11 requirements for computer validation.
11. 审查验证包、维护工单和其他可能受到集团或监管审核的相关文件。
Audit validation packages, maintenance work orders and other related documents that may be subject to Corporate or Regulatory audits.
12. 协助制定主工单、持续改进流程和程序以及偏差。
Assist with the development of Master Work Orders, CIP process and procedures and Deviations.
13. 支持工厂进行技术工作和研究，以确保生产的产品符合预期的试验目标，例如提高过程能力。
Support the plant in technical efforts and studies undertaken to assure products produced meet intended trial objectives e.g. enhance in-process capability.
14. 完成上级临时交办的任务。
Complete tasks temporarily assigned by superiors.

任职资格/Job Requirements：
1. 资格证书/Certificate：
无要求。No requirements.

2. 外语技能/Foreign Language Skills：
英语听、说、读、写流利
Fluent in listening, speaking, reading and writing English

3. 计算机软件技能Software Skills
熟练掌握WORD, EXCEL, POWERPOINT等办公软件
Proficient in WORD, EXCEL, POWERPOINT and other office software

4. 工作经验或专业背景/Work Experience or Professional Background：
至少8年受监管环境中的相关QA经验，对质量保证和制造流程（生产、物流、工程和绩效指标）有透彻的了解。
At least 8 years of relevant QA experience in a regulated environment with a thorough knowledge of Quality Assurance and Manufacturing processes(production, logistics, engineering and performance metrics).


5. 教育背景/Education Background
学士及以上，机械、电子、工程、化学、药学、生物学或微生物学或同等经验Bachelor’s degree or above, Mechanical, Electronic, Engineering, Chemistry, Pharmacy, Biology or Microbiology or equivalent experience

6. 其它要求/Others：
具有执行审核以及独立解决问题的经验。
Have experience in performing audits and working independently through troubleshooting issues.
有同时管理多项活动/项目、组织/确定工作优先顺序、按时完成任务以及准备计划和报告的能力。
Demonstrate the ability to manage several activities/projects at once, to organize/prioritize work, to meet deadlines and to prepare plans and reports.