Job Description Summary

tex

Job Description

在药品经营质量负责人的领导下指导公司放射性药品购进销售各环节的质量管理工作及时向领导汇报有关质量方面的问题对有关问题提出处理意见有效实施质量否决权

领导本部门工作人员认真履行药品经营质量管理规范其他适用的法律法规及内部规定的质量管理部门的职责有效开展质量管理工作达成本部门年度质量考核目标

指导各部门有效展开质量方针目标编制年度质量目标督促质量目标完成

负责组织公司起草修订公司药品经营质量管理体系文件并指导监督文件的执行对质量管理体系文件进行审核

定期组织召开质量评审会维护质量评审记录

负责指导设定计算机系统质量控制功能和计算机系统操作权限的审核

组织质量管理体系的内审和风险评估

负责不合格药品的确认及假劣药品的报告对不合格放射性药品的处理过程实施监督

负责药品质量投诉和质量事故的调查处理及报告

负责药品召回的管理

负责对供货单位和购货单位的合法性购进药品的合法性以及供货单位销售人员购货单位采购人员的合法资格进行审核组织现场审计并根据审核内容的变化进行动态管理组织对放射性药品供货单位及购货单位质量管理体系和服务质量的考察和评价

负责药品质量查询和质量信息的收集和管理并建立放射性药品质量档案

负责指导并监督自营库放射性药品收货验收储存养护出库复核退货运输等环节的质量管理工作

组织对受托运输方或储存方的运输储存条件和质量保障能力的审查

协助开展质量管理教育和培训

确保质量管理部有关记录档案的准确性和完整性

Education and qualification requirement/ 教育和资质要求

药品经营质量管理部门负责人应当符合中华人民共和国药品管理法及药品经营质量管理规范等有关法律法规规章和有关文件规定的资格要求不得有相关法律法规禁止从业的情形

药品经营质量管理部门负责人具有核医学药学临床医学或放射性化学相关专业大学本科以上学历和执业药师资格具有3年以上药品经营批发连锁总部质量管理工作经历能独立解决经营过程中的质量问题

熟悉药品管理法放射性药品管理办法等法律法规的要求熟悉放射性药品知识和辐射防护知识

Position: Head of Quality Management Department Radiopharmaceutical Distribution

Key Responsibilities

Under the leadership of the Quality Head of Radiopharmaceutical Distribution guide and oversee quality management across all stages of radiopharmaceutical procurement and sales; promptly report quality-related issues and propose solutions; exercise quality veto authority effectively.

Lead department staff in fulfilling responsibilities under Good Supply Practice (GSP) applicable laws regulations and internal policies; ensure effective quality management and achieve annual departmental quality targets.

Guide departments in implementing quality policies and objectives; develop annual quality goals and monitor progress.

Organize the establishment of quality management system documents and guide and supervise the implementation thereof; review system documents.

Regularly organize quality review meetings and maintain records;

Responsible for the audit of operation permission of computer system.

Guide the setting of quality control function of the computer system; Responsible for the review of access control of computer system.

Organize internal audits and risk assessments for the quality management system.

Confirm unqualified drugs report substandard or falsified drugs and supervise the handling thereof.

Responsible for investigation handling and reporting of quality complaints and quality accidents of drugs.

Manage drug recall processes.

Review legal qualification of supplier customer drug product sales personnel of supplier and purchasing personnel of customer; organize on-site audits and conduct dynamic management; Organize the audit and evaluation of the quality management system and service quality of drug supplier and purchaser.

Responsible for drug quality inquiries collect and manage quality information and establish drug quality archives.

Guide and supervise quality management in all stages of radiopharmaceutical handling in the selfoperated warehouse including receiving acceptance inspection storage maintenance ex-warehousing inspection returns and transportation.

Organize the evaluation on the transportation conditions and quality assurance ability of the carrier entrusted with transportation services.

Assist in carrying out quality management education and training.

Ensure accuracy and completeness of quality management records and archives.

Education & Qualification Requirements

Shall comply with the qualification requirements specified in the Drug Administration Law of the Peoples Republic of China and Good Supply Practice (GSP) and other relevant laws and regulations and shall be under no Job Forbidden by relevant laws and regulations.

Bachelors degree or above in relevant majoring of Nuclear Medicine Pharmacy Clinical Medicine or Radiochemistry shall have the qualification certificate of licensed pharmacist and working experiences in quality management (wholesale or chain headquarters) of drug distribution for more than 3 years and be able to solve quality issues in the process of drug distribution independently.

Familiarity with the Drug Administration Law of the Peoples Republic of China Radiopharmaceutical Management Measures and related regulations. Knowledge of radiopharmaceuticals and radiation protection principles.

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race color religion national or ethnic origin sex sexual orientation gender identity or expression age disability protected veteran status or other characteristics protected by law.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus and drive ownership always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.