履行高级QA技术员的职责,协助QA管理层维护质量管理体系。确保以下活动符合Fisher临床服务全球政策、所有适用于临床试验产品的包装和分发的相关法规和行业规范。
• Perform Incoming Inspection / Approval on Receiving and Returns.
执行来料检查/收货和退货的批准。
• Perform packaging inspection and checks (including Computerized Label Inspection).
执行包装检验和检查(包括计算机化标签检验)。
• Perform QA release of finished products in GPMS and adjust inventory status of warehouse materials.
在GPM系统中执行成品的QA放行,并调整仓库物料的库存状态。
• Perform self-inspection as qualified internal auditor if necessary.
必要时作为合格的内审员进行自检
• Perform ad-hoc duties as requested by line management.
执行部门经理要求的其他工作。
任职要求
• Education: Bachelor degree in life science, chemical or pharmaceutical/medical related.
教育背景:生命科学、化学或制药/医学相关专业的本科学历。
• Years of Experience: 3 yrs quality assurance or quality control working experience; about 2 yrs working experience in pharmaceutical industry; experience in production or manufacturing field of life science will be privileged.
工作经验: 3年质量保证或质量控制工作经验;2年以上制药行业工作经验;有生命科学生产或制造领域经验者优先。
• Knowledge: Advanced understanding and grasp of quality management, GxP, preferably the knowledge of clinical trial materials. Knowledge in supply chain or warehouse operation will be plus.
知识:对质量管理、GxP有较强的理解和掌握,最好有临床试验物料的知识。具备供应链或仓库操作知识者优先。
• Competency: Good communication skills. Good written and spoken English. Problem solving / Decision making. Details-oriented.
能力:良好的沟通能力,良好的英语听说读写能力。解决问题/决策,注重细节。