Senior QA Specialist

Core Job Responsibilities:

• Implement and maintain the Quality Management System in compliance with current China GSP and relevant laws and regulations.
• GSP及药品相关法律法规实施和维护公司的质量管理体系
• Be responsible for coordinating relevant departments and personnel to implement the requirements of the GSP laws and regulations on drug management.
• GSP的要求
• Organize the revision of quality management system documents guide and supervise the implementation of quality management procedures records and quality files.
• Responsible for reviewing the legality of Abbott S&Ts suppliers and distributors the legality of purchased drugs and the legal qualification of the sales personnel of the supplier and purchasers of the distributor and implementing dynamic management over the change in the review contents.
• Responsible for quality qualification and performance evaluation of the quality management system and service quality of suppliers customers and the TPL.
• Responsible for the collection and management of quality information and creating the drug quality files.
• Supervise and guide the TPL performing the drug inspection guiding and supervising the quality management in links such as drug procurement storage maintenance sales return and transportation.
• Based on the feedback from third-party logistics regarding acceptance maintenance sales transportation and other situations maintain the relevant records in the companys computer system and establish archives.
• Responsible for confirming the unqualified drugs and implementing supervision over the handling progress of unqualified drugs.
• Responsible for the collection investigation handling and reporting of the drug quality complaint and quality accident.
• Responsible for reporting drug quality complaints adverse events counterfeiting tampering diversion and product theft situations. Responsible for reporting the fake and substandard drugs.
• Responsible for guiding the setup of the computerized systems quality control function. And be responsible for reviewing the operating authorization of the computerized system and for establishing and upgrading the basic quality management data.
• Responsible for quality complaints and adverse reaction reporting as well as assisting the MAH on product recall activities.
• MAH进行产品召回活动
• Assist the Head QA in organizing the internal audit/self-inspection and risk evaluation of the quality management system.
• /自查和风险评估
• Develop Abbott S&Ts quality training plan and assist in conducting quality training.

Create Isotrain accounts for new employees and assign corresponding courses to them as per Abbotts requirements.

• Isotrain账户并按照雅培要求为其分配相应的课程

• Other Works/functions that may be assigned.
• /职能

Supervisory/Management Responsibilities:

Direct Reports: None.

Indirect Reports: None.

Position Accountability/Scope:

The position is responsible for implementing maintaining and continuously improving the Quality Management System (QMS) in accordance with Chinas Good Supply Practice (GSP) the Drug Administration Law and other relevant regulatory requirements. This role ensures quality oversight of drug operations at Abbott S&T which includes the qualification of suppliers and distributors drug procurement storage distribution transportation recall procedures computerized systems and third-party logistics management. The position also has the authority for regulatory reporting risk management internal auditing and handling quality issues to ensure ongoing compliance product quality and patient safety.

该职位负责质量管理体系QMS的实施维护和持续改进以符合中国GSP药品管理法和相关法规的要求该职位确保雅培科技药品运营的质量监督包括供应商和经销商资格药品采购储存分销运输召回计算机化系统和第三方物流管理该职位有权进行法规报告风险管理内部审计和质量问题处理以确保持续的合规性产品质量和患者安全

Minimum Education:

• Bachelors degree or above in Pharmacy Medicine or related disciplines.

Minimum Experience/Training Required:

• Industry experience: 3 years of experience in a pharmaceutical wholesale enterprise is preferred.
• 3年以上药品批发企业工作经验优先
• Position experience: More than three years of working experience in drug operations and quality management with the ability to settle quality problems in the operation process independently.
• 3年以上药品经营质量管理工作经验能独立解决经营过程中的质量问题
• Certificate required: Qualification as a licensed pharmacist.
• Language skills: Proficient in written and spoken Chinese as well as good English reading and writing abilities.
• Computer skills: Familiarity with MS Office applications especially Excel and PowerPoint data analysis.
• MS Office办公软件特别是Excel和PowerPoint数据分析
• Other Special requirements:

• Good coordination and communication skills; effective management of various departments within GSP.
  • GSP内各部门进行有效管理