负责制定有关质量方面的管理制度。编写公司质量政策草案并报总经理批准后颁布执行。
收集、分析质量信息，掌握质量动态，处理质量问题。
学习有关产品质量方面的法律、法规。注意质量控制方面的科学发展方法。
负责质量管理文件和质量标准的编写、修订和实施。
参与文件管理及文件的编写和修订。
对涉及产品质量活动的全过程进行有效的监控。
根据《规范》要求，负责制定质量保证系统，组织实施并承担下列职责：
制定和修订物料和产品的内控标准和检验操作规程；
制定取样和留样制度。
制定检验用设备、仪器、试剂、试液、试药、标准品（或对照品）、滴定液、培养基等管理办法并实施。
决定物料和中间产品使用与否。
对批生产记录进行审核。审核内容包括配料、称量过程中的复核情况，各生产工序检查记录、清场记录，半成品质量检验结果、偏差处理、成品检验结果等。符合要求并有审核人员签字后方可将产品放行。
审核不合格品处制定质量管理和检验人员职责。
负责有关质量文件的文档管理。
负责生产全过程的监督与控制
。负责对产品质量问题退货和收回以及用户投诉的处理，监督产品的销毁。
负责药品不良反应监测及报告。
．参与实施GMP自检理程序。
參考答案:Collect, analyze the quality of information, to monitor the quality of dynamic handling and quality.
Learn about the product quality laws and regulations.The attention to quality control, scientific approach to development.
Quality management and quality standards for document preparation, revision and implementation.
Participate in the preparation and revision of documents and document management.
Involved in the entire process of product quality for effective monitoring.
According to the "standard" requirement for the development of quality assurance system, organization and implementation and undertake the following duties :
Formulation and revision of the internal control standards and testing of materials and products practices;
Develop sampling and sample keeping system.
Formulated using test equipment, apparatus, reagents, test solution, the test drug, standard (or tablet), titrant,management approach and the implementation of the medium.
Decide whether or not to use materials and intermediate products.
Production records for audit.Audit includes batching, weighing the review process, the various manufacturing processes and inspection records-records,semi-quality test results, the error handling, product test results.Meet the requirements and audit staff products can only be released after the signing.
Unqualified audit and Inspection Service in quality management responsibilities.
Responsible for the quality of the paper document management.
Responsible for the supervision and control of the entire process.
Responsible for product quality and consumer complaints on the treatment and recovery of goods, products supervision of the destruction.
Responsible for the monitoring and reporting of adverse drug reactions.
GMP self-handling procedures involved.
