质量管理专员-北京-00049

Key Objectives/Deliverables：
1. 协助支持企业质量体系建立和维护，并持续改进。
Assist to develop and maintain the quality system, ensure systemcontinuously improvement.
2. 协助负责临床批生产质量管理相关工作。
Assist to support for the quality management of clinical batch production.
3. 协助确保原辅料、包装材料、中间产品、待包装产品、成品符合经注册批准的要求和质量标准。
Assist to ensure raw materials, packaging materials, intermediateproducts, products to be packaged and finished products meet theregistered and approved requirements and quality standards;
4. 协助承担产品放行的职责，确保在产品放行前完成对批记录的审核，确保每批已放行产品的生产、检验均符合相关法规、药品注册要求和质量标准。
Assist for product release, ensure that the audit of batch records iscompleted before product release, and ensure that the production andinspection of each batch of released products comply with relevantregulations, drug registration requirements and quality standards;
5. 协助支持相关变更, 投诉等原因调查及风险评估，及时报告并提出建议，负责确认处理结果。
Assist to support the cause investigation and risk assessment of changecontrol and complaint, timely report and verify the result.
6. 协助负责企业的内外部检查，并对检查整改措施进行跟踪管理。
Assist to external and internal inspection, and follow up and manage thecorrective measures per inspection.
7. 协助支持企业的相关召回活动并进行跟踪管理。
Assist to support the related recall activities and follow up management.
8. 协助负责支持质量负责人开展企业定期管理评审工作。
Assist to support quality head to implement periodical management reviewwork
9. 协助改进质量管理体系。
Contribute to QA function in developing quality management system
10. 协助支持维护电子化质量管理工具。
Assist to support and maintenance of electronic quality management tools
11. 配合各项审计的进行。
cooperate with each audit.
12. 负责上级安排的其它任务。
Responsible for other tasks assigned by supervisor.
任职资格：
1. 药学或化学本科以上学历，2020或2021年7月国内或海外应届毕业生。
Bachelor or above degree in Pharmaceutical, Chemical related field.
2.具备很好的团队精神和较强的沟通和协作技能。有较强的人际关系处理能力
Good team spirit and strong communication and collaboration skills.Strong interpersonal skills, especially in conflict situations. Abilityto establish relationships with colleagues in different departments andat different levels.

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