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[武汉]鼎康(武汉)生物医药有限公司

  1. 发布时间:2020-08-14
  2. 工作地点:武汉
  3. 职位类型:全职
  4. 来源:前程无忧(51JOB)
  5. 职位:验证专员/Validation Engineer
职能类别:其他

岗位描述:
? Active participation in compliance and continuous improvement of the Company Quality Management System with specific attention to validation lifecycle processes;
积极参与公司质量管理体系的合规和持续改进,特别关注验证生命周期过程;
? Contributing to the safe operation of company’s facilities through personal initiative and adherence with Company procedures and ensure zero lost-time injuries;
通过个人主动性和遵守公司程序,促进公司生物技术设施的安全运行,保证零工伤;
? Lead validation risk assessment workshops to document failure modes and mechanisms for control of critical-to-quality attributes, draft system and component criticality assessments;
领导验证风险评估,记录控制关键质量属性的故障模式和机制,起草系统和部件关键性评估;
? Preparing validation plans and protocols: DQ, IQ, OQ, and PQ;
准备验证计划和方案:DQ、IQ、OQ和PQ;
? Reviewing specifications for compliance with company quality standards and performance criteria;
审查规范是否符合公司质量标准和性能标准;
? Maintaining the validated state of direct-impact systems in compliance with Good Manufacturing Practice (GMP);
保持直接影响系统的验证状态符合药品生产质量管理规范(GMP);
? Review of Factory Acceptance and Site Acceptance Test (FAT and SAT) documents prepared by Vendors;
审查供应商编制的工厂验收和现场验收测试(FAT和SAT)文件;
? Coordinating preparation of Computerized System Validation Plans in collaboration with Subject Matter Experts;
与主题专家合作,协调计算机化系统验证计划的编制;
? Executing validation protocols in compliance with Good Documentation Practice and approved procedures. Preparing validation reports;
根据Good Documentation Practice和批准的程序执行确认和验证方案,准备编制验证报告;
? Preparing standard operating procedures and associated records covering the validation lifecycle: risk assessments, URS, FS, DS, Qualification Protocols and Reports;
编制涵盖验证生命周期的标准操作程序和相关记录:风险评估、URS、确认方案、报告;
? Preparing standard procedures for operation of testing equipment used in validation testing such as KAYE 2000 thermal mapping systems;
为验证测试中使用的测试设备(如KAYE 2000验证系统)的操作制定标准程序;
? Identify validation requirements for proposed changes and corrective actions, raising and timely closure of Qualification Deviations;
确定拟议变更和纠正措施的验证要求,提出并及时关闭确认偏差;
? Selection and purchase of equipment and consumables required to execute validation activities;
选择和购买执行验证活动所需的设备和消耗品;
? Other work arranged by superior leaders.
上级领导安排的其他工作。


公司简要介绍:

公司名称:鼎康(武汉)生物医药有限公司
公司类型:外资(非欧美)
公司介绍:


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