OQ Specialist OQ专员招聘_葛兰素史克制药（苏州）有限公司最新招聘信息-猎才医药网

OQ Specialist OQ专员 江苏省

葛兰素史克制药（苏州）有限公司

月薪：

无工作经验
招1人
11-23 发布

职位描述

职位描述： Key Responsibilities岗位描述:?Improve and standardize operational quality management process against GMP, GQP & GQMP, perform gap analysis reports, establish action plan and prepare SOPs. 根据GMP, GQP & GQMP的要求不断改进和优化质量保证系统的流程。?Review the batch records, evaluate the product quality so as to ensure the products to be released/rejected properly完成批记录审核，评估产品质量，确保正确放行/拒绝产品?Ensure on line GMP inspection for relative area is carried out periodically , such as packaging, production, dispensation and storage area; Ensure correct behavior at shopfloor to meet GMP and SOP requirements, escalate the issues to proper level 对所有工厂内的相关区域包括包装/制造/备料/储存区域进行GMP巡检，保证时时了解工厂内 GMP执行水平，对违反GMP及SOP的行为进行制止，提出纠正措施并向上级主管报告。?Track and review the quality activities, analysis the quality status. Quality activities including: supplier management, the quality status of incoming materials, utility quality status, the quality status of product（including intermediate product and final product, the status of calibration and maintenance, implementation of change/validation, the status of customer complaints investigation/handling/feedback, etc. 跟踪和回顾质量活动，分析质量状况。质量活动包括：供应商管理、来料质量状况、公用设施质量状况、产品（包括中间产品和成品）质量状况、校验维护状况、变更/验证实施、客户投诉调查/处理/反馈情况等等?Prepare annual product review report. 组织编制年度产品回顾报告。?Deal with deviation ,find out root cause , point out and trace corrective action and preventive action追踪偏差处理，调查问题根源，提出和落实和纠正预防措施。?Ensure L1 audits are carried out for the production area and make sure production周期性执行所辖生产区域的质量内审，保证符合相关现行法规和公司政策要求。?Review batch record before material/bulk release, make sure this follows strictly product release specification and that deviations are thoroughly investigated. 物料、半成品放行前批档案审核，保证产品放行符合规范要求且无失误。?Reduce defective ratio and Customer complaints. Participate in investigation and handling of customer complain, product return and recall, and follow up CAPAs降低产品缺陷率和客户投诉。参与客户投诉、退货、召回的调查和处理，并跟进整改措施。?Carry out other works arranged by Quality manager开展质量经理安排的其他工作Specialised Knowledge 专业知识:?Major in Pharmacy or related药学或相关专业。?Have more than 3 year experience of application of GMP to pharmaceuticals manufacturing processes. Release and workshop experience with priority 3年以上制药行业GMP应用经验，有放行及在线经验优先。?Good communication and coordination skill良好的沟通和协调技巧。?Basic command of computer skill基本计算机能力。?English skill with priority英语能力优先。职能类别：药品生产/质量管理