原料药QA经理/副总监

面议

绍兴市

刷新时间：2023-11-21

职位描述

工作内容Job Description
 审核公司质量管理文件和质量管理体系的合规性；
Review the compliance of the quality management document with the new published laws and regulations.
Responsible for the response to the corrective action of the observations relevant to responsibility during the audit
 负责变更、偏差、CAPA、投诉、退货、召回及质量协议的管理；
Management of Change Control, Deviation, CAPA, Complaint, Return, Recall and Quality Agreement management.
 监督质量管理系统的执行是否符合要求；
Supervise the implementation of the quality management system to meet the requirements.
 审核与生产相关的记录；
Review the records related to production.
 现场日常**，确保现场执行和SOP、法规要求的一致性；
Responsible for on-site daily inspection, and make sure the compliance between operation on-site and SOP and regulation.
 负责物料相关工作的管理；
Responsible for material management related work.
 确保放行与拒收原材料、中间体、包装材料和标签的系统符合SOP要求；
Ensure the system of release or reject raw materials, the intermediates, packaging materials and label is complied with SOP.
 负责Non-GMP文件统一编号的管理；
Responsible for the management of Non-GMP document numbering.
 负责绍兴厂区的Non-GMP SOP管理；
Responsible for Non-GMP SOP management of Shaoxing Site.
 负责本部门文件、档案的借阅登记，保管工作；
Responsible for lending, registering and archiving the documents and files in QA department.
 负责编制文件和档案的管理目录；
Responsible for preparing the list of document and file.
 负责文件接收、发放、登记、分类、归档等的管理；
Responsible for receiving, distributing, registering, classifying, archiving of document.
 负责客户文件的登记、存档管理；
Responsible for the registering, archiving of ****** document.
 负责新员工质量意识培训，本部门培训工作及绍兴公司各部门培训文件管理；
Responsible for quality awareness training for new employees, managing the training of QA department and the training documents of each department.
 负责编制本部门年度培训计划，整理培训记录，定期考核培训效果、完成培训总结；
Responsible for the preparation of the annual training plan, organizing training records, assessment of the training effectiveness and completing training summary.
 负责编制质量相关的培训资料，协助部门负责人对公司全员开展质量培训；
Responsible for the preparation of quality-related training materials, and assist to carry out quality training for staff.
 负责编制质量相关的考核试卷，组织公司全员质量考核；
Responsible for the preparation of quality related examination papers, organizing quality assessment for all personnel.
 督促其他质量相关部门培训工作，整理其他部门归档的培训文件。
Supervise the training of other quality related departments, organize and archive the training files of other department.
 管理组内的工作并解决工作中的问题；
Responsible for managing the work assigned to the and solving work problems.
 负责与相关部门团队协调沟通，将工作任务进行合理分配；
Responsible for communicating with relevant department and team, assign work reasonably.
 协助部门领导负责外部质量活动沟通工作；
Assist department leader to communicate with external quality activities

其他要求

招聘人数：5人
职能类别：QA总监/QA经理/QA主管

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。