职位详情
QMS-GSP质量经理
2.5-4万
通化安睿特生物制药股份有限公司北京分公司
北京
5-10年
本科
04-11
工作地址

平安幸福中心A座

职位描述
职责内容Responsibilities
负责集团GSP质量管理体系的策划、实施与持续改进,确保符合《药品经营质量管理规范》要求
Responsible for the planning, implementation and continuous improvement of GSP quality management system(QMS)in headquarter of Anrate to ensure compliance with GSP
建立集团GSP相关质量体系管理文件并持续完善,并监督相关流程的执行
Establish the relevant GSP QMS documents for headquarter of Anrate and continuously improve, and supervise the execution of related processes
制定集团GSP相关培训计划,主导或协助开展GSP相关法规、流程及专业培训,并监督确认培训的效果
Develop a GSP related training plan for headquarter of Anrate, lead or assist in conducting training for GSP related regulations, procedures, and profession, supervise and confirm the effectiveness of the training
指导集团下属分、子经营公司依照法规、指导原则相关要求建立合规的质量管理体系,并监督执行
Guide the subsidiaries and affiliates of Anrate to establish a compliant quality management system in accordance with the relevant requirements of laws and regulations, and supervise the implementation
主导或协助集团及其分、子公司的内部和外部审计,包括但不限于GSP认证、突击检查和年度自查,以确保成功。
Lead or assist in internal and external audits, including but not limited to GSP certification, unannounced inspections and annual self-inspections, for headquarter of Anrate and its subsidiaries and affiliates to ensure the success.
协助对GSP相关质量文件、记录进行管理与存档。
Assist in the management and archiving of GSP related quality documents and records.
完成领导安排的其他工作。
Complete other tasks assigned by the leader.
任职要求Qualifications
药学、化学、医学等相关专业,本科及以上学历
Bachelor degree or above in pharmacy, chemistry, medicine and other related majors
医药行业7年以上工作经历,其中至少有3年以上GSP质量管理工作经验
More than 7 years of work experience in the pharmaceutical industry, including at least 3 years of GSP quality management experience
熟悉国内外GSP相关法规及原则,具备质量管理的专业知识和技能
Familiar with GSP regulations and principles at home and abroad, with professional knowledge and skills in quality management
良好的逻辑思维能力、计划与执行能力、沟通能力,具备较强的学习能力
Good logical thinking ability, planning and execution ability, communication ability, and have strong learning ability
有良好的英语听说读写能力
Good oral and written English skills
能够接受少量出差
Able to have business trips occasionally.

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