GSP QO Manager

Position Purpose

该职位全面执行质量管理部的质量管理职责，采取有效措施以确保所经营药品的质量，保证质量管理

体系有效运行。负责总部质量内部审计工作。

The role is to fully implement the quality management responsibilities and take effective measures to ensure the quality of business drugs and the effective operation of the quality management system. Responsible for Global Self-inspection.

Main Areas of Responsibility / Accountability

GSP主要职责/ Main Responsibilities for GSP

组织贯彻执行并督促相关部门和岗位人员执行药品管理的法律法规及GSP的要求。

Organization, implement and urge relevant departments and personnel to implement laws and regulations of drug management and GSP requirements.

负责起草、修订药品质量管理制度，审批药品质量管理操作规程，并具体指导、督促相关部门和

岗位人员落实制度及规程。

Be responsible for drafting and revising quality management SOPs and approving operation procedures, and specifically guiding and urging relevant departments and personnel to implement the SOPs and procedures.

负责公司药品经营过程中的质量监督检查工作，组织“质量方针、目标实施情况的展开和检

查”、“质量管理体系的管理评审”、“GSP内审”、“质量风险评估”。

Be responsible for the quality supervision and inspection of drugs operation, and organize " the

implementation and inspection of Quality Policy and Objectives", "Quality Management Review" and

"GSP Internal audit", "Quality Risk Assessment". 负责对供货单位、购货单位和购进药品进行审核，并根据审核内容的变化进行动态管理，组织对药品供货单位及购货单位的质量管理体系和服务质量进行考察和评价。

Be responsible for auditing suppliers, customers and products, and conduct dynamic management

according to the changes of audit contents, and organize the inspection and evaluation of the quality

management system and service quality of drug suppliers and customers.

负责指导并监督药品采购、销售、退货等环节的质量管理工作；负责质量工作的对外业务联系，

包括3PL质量问题的处理。

Be responsible for guiding and supervising the quality management during drug purchase, sales, and

return; Be responsible for the external contacts of quality works, including to handle 3PL quality problem.

负责对3PL的定期抽查和质量内审。

Be responsible for regular inspection and 3PL yearly internal audit.

负责药品质量事故的调查、处理及报告。

Be responsible for drug quality accident investigation, treatment and report.

负责不合格药品的确认，严格监控不合格药品的处理过程并做好记录。

Be responsible for unqualified drugs verification, strictly monitor the handling process of unqualified

drugs and make records.

协助采购部做好年度的采购计划及药品进货质量情况评审。

Assist purchasing department to complete the annual purchasing plan and review the quality of drug purchase.

负责计算机系统质量管理基础数据的有效管理，质量管理基础数据的建立、更新及审核、确认生效及锁定。

Be responsible for the effective management of the quality master data in computer system, and the establishment, update, review and verify, effectiveness and locking of the master data.

负责计算机系统操作权限的制定和审核，并定期跟踪检查，监督各岗位人员严格按规定流程及要求操作系统。

Be responsible for determine, review and verify operation permissions of computer system, regularly tracking and checking, and supervising personnel operating system in strict accordance with the process and requirements.

审核经营业务数据的修改；处理系统中涉及药品质量的有关问题。

Be responsible for reviewing the business data changes; handling issues related to drug quality in system.

综合各部门的培训需求，制定年度的培训计划，协调各部门的年度培训计划的执行，负责公司员工药品经营质量管理方面的教育培训。

Integrated department training needs, establish the annual training plan and coordinate the implementation of annual training plan of each department, and be responsible for quality management training for employees.

负责药品召回管理、假劣药的报告。 Be responsible for drug recall management and counterfeit drug report.

负责与总部信息系统管理部之间的信息事务的沟通与协调工作。

Be responsible for communication and coordination with IT headquarters about the quality based data.

负责药监检查接待和跟进。

Be responsible for BoH inspection and follow.

技能

Leadership Skills:

支持 SCESQ 质量目标的执行 Supporting the execution of SCESQ Quality objectives.

促进与SCESQ目标和战略一致的目标的执行

Facilitate execution of objectives consistent with SCESQ Goals and strategies. 描述Role Description GSP质量体系管理

GSP Quality System Management

总部检查和内部审计 Global Inspections and Internal Audit

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control#LI-PFE