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.
以担保或任何理由索取财物,扣押证照,均涉嫌违法,请提高警惕