USACares Jobs

Job Information

Abbott Quality Specialist in Shanghai, China

主要工作职责 Key Responsibilities : ( 概括关键职责、每项职责所要达成的结果 / primary deliverables of roles)

完全掌握相关质量法规、公司SOP和产品生产工艺,并能够指导和监督他人按照SOP进行操作。

Fully understand related quality regulation, company SOP and manufacturing process. To guide and supervise others to follow these SOPs.

审核批相关生产记录与质量控制记录。确保正确地完成全面的审核,所有相关的偏差已结束并被适当地记录。

Review the batch related production records and quality control records, ensure that the detailed reviews have been completed correctly and any deviations are closed and documented appropriately.

深入现场,完成生产/检验、物料存储发放环节的每日巡检;对于巡检中发生的违反SOP或质量规范的问题以及质量隐患提出解决方案并及时向主管汇报。

Hands-on management, finish the daily inspection for manufacturing, QC testing, material delivery and etc.. For the non-conforming issues and quality risk found during the inspection, raise solving protocols if possible and report to supervisor ASAP.

协助主管及领导相关部门进行不合格以及投诉调查;定期对不合格以及投诉进行趋势分析以及相关措施落实的跟进。

Assist supervisor and lead related dept. to finish non-conformance or complaint investigation. Conduct trending analysis for non-conformance and complaint on a regular basis and follow up the action implementation.

不合格处理,与相关部门紧密合作跟进在日常运营、现场巡视、内审、外审、供应商审计以及客户投诉等中发现的与产品或原材料相关的不合规情况和纠正预防措施。确保执行了完整的调查,纠正预防措施得当并符合相关流程和法规规定。

Non-conforming handling and work closely with relevant departments to follow up the all the non-conforming issues and CAPA related to products and raw materials from routine operation, Gemba walk, internal audit, external audit, supplier audit and customer complaint, etc.. Assure that the investigation has been performed thoroughly and the corrective and preventive actions are appropriate and comply with relevant procedures and regulations.

针对遇到的问题,进行分析并提出初步的解决方案。

Analyze problems met in operation and propose preliminary solutions.

确保文件及记录根据需要被及时更新,要求可能来自于更改控制,验证,项目与SOP的更新等。负责协调标签更改申请与包装信息标准的建立,修改与批准。

Ensure the updating of SOP & batch documentation when it is required due to for examples change control, validation activities, projects, SOP updating. Responsible for coordinating the approval of LCCR and packaging information specification.

SAP系统中Master Data及BOM的维护。

Maintain Master Data and BOM in SAP system

完成质量保证主管布置的其他任务。

Undertake other tasks that assigned by QA Team Leader.

任职条件 Qualifications : ( 该职位任职者所需具备的成功要素 / Key success factors the job holder should have)

  • 文化程度Education:

生物、医药、化工或电子相关专业的本科及以上。

Bachelor’s degree or above (biology, medicine, chemical industry or electronics related specialty).

  • 任职经验Working Experience:

12年及以上药厂、医疗器械、体外诊断试剂企业质量部相关工作经验,熟悉整个过程的监控和管理,能编制相关质量管理体系文件及生产工艺文件。

12 years or above of quality department working experience in pharmaceutical/medical device/in-vitro diagnostics company. Familiar with the production process, be able to draft quality system documentation and production process procedure.

  • 专业知识/技能Professional Knowledge/Skill:

熟悉GMP、ISO、FDA与相关法规的质量管理体系要求。

Familiar with quality system requirements of GMP, ISO, FDA and related regulatory.

具有ISO13485:2016质量体系内审员资格为佳。

ISO13485:2016 Internal Auditor certificate is preferred.

  • 计算机及外语水平Computer & Language Skill:

良好的英语沟通能力。

Good English skills both spoken and written.

具备一定的电脑操作技能。

Certain application capability of computer.

  • 能力要求Competency:

有亲和力、责任心,良好的逻辑思维、组织协调、沟通和表达能力。

Have affinity, willing to take responsibility, good logical thinking, organize, coordinate, communication and presentation skill.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

DirectEmployers