质量工程师QA

-Release product batch on behalf of Quality Manager. 代表质量经理负责产品放行。

-Analyze for the processing gap, handle non-conformance (NC), complaint and CAPA plan generation.分析工艺流程差异、处理不符合项、投诉，并制定纠正和预防措施。

-Update WI, SOP independently. 独立更新作业指导书、标准操作流程。

-Coordinate the internal audit for ISO 13485 and ISO

17025. 协调ISO 13485和ISO 17025的内部审计。

2.Duties 岗位职责

-Quality Management System & Audit 质量管理体系和审核

-Keep the efficiency approach for documents, working instructions, forms control to meet the standards and customer requirement and maintain in the document control system EQMS.管理并确保文件、作业指导书、表格的有效性，以满足标准和客户要求，并维护在文件控制系统在线质量管理系统(EQMS)中；

-Assist Quality Manager to deal with Notify body, FDA and the customer audits.协助质量经理处理第三方审核公司、FDA 和客户审核；

-Coordinate and conduct internal audit and actions follows-up.协调并开展内部审计，并跟进采取的行动；

-Maintain Lab management system for CNAS accreditation.维护实验室CNAS 认证管理系统；

-Quality Assurrance质量保证

-Follow up the action taken as per response report submission to customers when it is required. 根据需要向客户提交响应报告并跟进所采取的行动；

-Review the batch record for each cycle and ensure the product release accurately.检查每个Cycle的批次记录并确保准确的产品放行；

-Assist the Quality Manager for all quality failure investigation and quality improvement (CAPA) tracking in global system CQMS. 协助质量经理在全球质量管理系统(CQMS) 中跟进所有质量事故调查和质量改进 (纠正预防措施) 行动；

-Others 其他

-Equipment’s calibration master plan monthly follows-up.跟进每月设备校准总计划；

-Supplier evaluation according to the evaluation interval of "approved supplier".根据"经批准的供应商"的评估差距对供应商进行评估；

-Pest control monthly follow-up. 跟进每月虫害控制；

-Other tasks assigned by Quality Manager. 质量经理分配的其他任务。

3. Requirements 要求

-Bachelor degree in biological/chemical or related science.生物/化学或相关科学本科学历；

-Minimum 5 years’ experience in a QA/Quality function in a GMP environment. 在 GMP 环境中QA/质量部门的至少 5 年的工作经验；

-Experience in audits by customers, Notify Body and licensing authorities is essential.有客户审核、第三方审核机构和许可机构的审核经验者优先考虑；

-Familiar with the ISO13485 / ISO17025 standards or have internal auditor certificate is preferred.熟悉ISO13485 / ISO17025质量标准者或具备内审员证书者优先考虑；

-Be familiar with quality analysis tools, such as plato, FMEA etc.熟悉质量分析工具，如柏拉图、潜在失效模式等；

-Strong problem solving skills. 优秀的解决问题能力；

-Good Internal audit skill. 良好的内部审核技巧；

-Conformity, will not break rules. 合规化操作，不会违反规则；

-Good communication skills and focus on customers. 良好的沟通技巧，关注客户；

-Ability to work independently. 具备独立工作的能力；

-Good team player/team leader. 良好的团队合作者和团队带头人；

-Motivated and able to motivate others. 主动自发并能激励他人；

-Skilled in Word / Excel / PowerPoint, fluent in English and Mandarin. 熟练使用Word, Excel, PowerPoint，中英文流利。