职位目标 Job Purpose:
协助产品及过程质量保证经理监控和管理与质量相关的各个流程,确保公司放行用以销售的产品符合相关标准与法规要求。
Assist QA Manager, PQA to supervise all quality relevant process and assure that the products meet relevant specifications and regulations before release for sale.
主要工作职责 Key Responsibilities:
1. 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.
2. 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.
3. 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跟进汇报。
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 and follow up, report on a timely manner.
4. 协调相关部门开展产品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。
Coordinate related dept. for finish product non-conformance or complaint investigation. Conduct trending analysis for non-conformance and complaint on a regular basis and follow up the action implementation.
5. 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 corrective and preventive actions are appropriate and comply with relevant procedures and regulations.
6. 能独立分析遇到的问题,并能够提出相应的解决方案。
Able to analyze problems and put up solving protocols, driving forward.
7. 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 & 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.
8. SAP系统中Master Data及BOM的维护。
Maintain Master Data and BOM in SAP system
9. 完成经理布置的其他任务。
Undertake other tasks that assigned by PQA Manager.
任职条件Qualifications:
1. 生物、医药、化工、食品或电子相关专业的本科及以上。
Bachelor’s degree or above (biology, medicine, chemical industry, food or electronics related specialty).
2. 3年及以上药厂、医疗器械、体外诊断试剂, 食品或电子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。
3 years or above of quality department working experience in pharmaceutical/medical device/in-vitro diagnostics/food/electronics company. Familiar with the production process, be able to draft quality system documentation and production process procedure.
3. 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.
4. 具有ISO13485:2016质量体系内审员资格为佳。
ISO13485:2016 Internal Auditor certificate is preferred.
5. 良好的英语沟通能力。
Good English skills both spoken and written.
6. 具备一定的电脑操作技能。
Certain application capability of computer.
7.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.
