QA Specialist

Job Description SummaryDevelop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Impacts quality of own work and the work of others on the team. Focused on execution of standard enabling activities/provision of advice subject to policy and work routines within an enabling discipline. There may be some latitude to rearrange the sequence to complete task/duties based on changing situations.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

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Job Description

在药品经营质量管理部负责人的领导下开展放射性药品经营质量管理工作，督促相关部门和岗位人员执行放射性药品经营管理的法律法规及规范；

负责药品质量查询和质量信息的收集和管理，并建立药品质量档案；

指导并监督药品采购、储存、养护、销售、退货、运输等环节的质量管理工作；

负责不合格药品的确认和假劣药品的报告，对不合格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；

负责指导设定计算机系统质量控制功能；负责质量管理基础数据的建立及更新；

指导仓库验证、校准相关设施设备；

负责药品召回的执行；

协助开展质量管理教育和培训；

参与公司质量管理体系的运行，参与内审和风险评估。

起草、修订质量部质量管理体系文件。

部门负责人交办的其它工作及其他应当由质量管理部门履行的职责。

Education and qualification requirement/ 教育和资质要求

药品经营质量管理人员应当符合《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。

质量管理人员应当具有药学中专或核医学、临床医学等相关专业大学专科以上学历或者具有药学初级以上专业技术职称，经过核医学及药学专业知识培训，熟悉放射性药品经营质量管理工作。

Perform quality management duties for radiopharmaceutical operations under the leadership of the Quality Department Head, ensuring compliance with relevant laws, regulations, and standards.

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

Guide and supervise quality management at all operational stages, including procurement, storage, maintenance, sales, returns, and transportation.

Confirm non-conforming products, report counterfeit or substandard drugs, and oversee the handling process of non-conforming products.

Responsible for investigation, handling and reporting of quality complaints and incidents of drugs .

Guide the setting of quality control function of the computer system; establish and update quality management data; Responsible for the establishment and update of basic data of quality management;

Supervise validation and calibration of relevant facilities and equipment in the warehouse.

Execute drug recall.

Assist in carrying out quality management education and training.

Participate in the operation of the company’s quality management system, internal audits and risk assessments.

Prepare and revise quality management system documents for the Quality Department.

Perform other duties assigned by the department head and fulfill responsibilities required of the Quality Management Department.

Education & Qualification Requirements

Shall comply with the qualification requirements specified in the Drug Administration Law of the People’s 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.

Have a degree of technical school in pharmacy or college degree or above in majoring of Nuclear Medicine, Clinical Medicine etc., or a junior level professional and technical title or above in pharmacy.

Completed training in nuclear medicine and pharmaceutical knowledge, and familiar with quality management practices related to the distribution of radiopharmaceutical.

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 you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.