Job Description Summary

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Job Description

Key responsibilities/ 主要职责

药品经营质量负责人全面负责放射性药品经营质量管理工作独立履行职责在企业内部对放射性药品质量管理具有裁决权督促企业相关部门有效履行药品经营质量管理规范规定的职责

贯彻执行有关放射性药品经营质量管理的法律法规和行政规章

统筹安排公司质量管理相关工作并指导落实规范公司的经营活动使公司的经营管理合规科学

参与公司质量方针和总体质量目标的制订对各部门分解的质量目标进行审核并监督实施

主持公司质量管理体系的建设协助企业负责人完善公司质量管理体系对质量管理体系文件进行审核审批

组织质量管理体系内审活动推进质量管理体系有效运行组织实施质量改进措施并报告质量管理体系的运行情况

参加质量评审会议评估质量管理体系运行情况和质量风险

负责首营企业和首营品种及客户资质的审批

负责验证工作的监督指导审批审批验证方案和报告

负责可疑放射性药品和不合格品处理审核审批

指导质量事故的调查和处理并对质量事故报告进行审核

听取质量管理部关于质量工作情况的汇报并对有关质量问题给出处理意见

Education and qualification requirement/ 教育和资质要求

药品经营质量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

药品经营质量负责人由高层管理人员担任

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以及3年以上药品经营批发连锁总部质量管理工作经历在质量管理工作中具备正确判断和保障实施的能力

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: Quality Head for Radiopharmaceutical Distribution

Key Responsibilities

Take full responsibility for the quality management of radiopharmaceutical operations independently fulfil his/her responsibilities and has independent authority and decision power over the quality management of radiopharmaceuticals within the enterprise.

Ensure compliance with the Good Supply Practice (GSP) for pharmaceuticals and relevant laws regulations and administrative rules.

Oversee and guide company-wide quality management activities ensuring business operations are compliant standardized and scientifically sound.

Participate in the development of the companys quality policy and overall quality objectives; review departmental quality targets and monitor implementation.

Lead the establishment and continuous improvement of the companys quality management system; review and approve system documentation.

Organize internal audits drive effective operation of the quality management system implement corrective actions and report on system performance.

Attend quality review meetings to assess system performance and evaluate quality risks.

Approve qualifications of new suppliers new products and new customers.

Supervise guide and approve validation activities including validation protocols and reports.

Review and approve handling of suspected radiopharmaceuticals and non-conforming products.

Guide investigations and resolution of quality accidents; review quality accident reports.

Receive reports from the Quality Management Department and provide decisions on quality-related issues.

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.

Should be a senior management-level position.

Bachelors degree or above in Nuclear Medicine Pharmacy Clinical Medicine or Radiochemistry and qualification certificate of licensed pharmacist working experiences in quality management of drug distribution (wholesale or chain headquarters) for more than 3 years with proven ability to make sound judgments and ensure execution.

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.