Responsibilities:
To perform the role of Sr. QA Technician, assist QA Management in maintaining quality management system. Ensure the following activities in compliance with Fisher Clinical Service Global Policy, all relevant regulation and industry recommended practice applicable to the packaging and distribution of clinical trial materials
职责:
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
Knowledge, Skills, Abilities:
知识,技能,能力:
• 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。
医药行业,2-3年经验,英语读写要好,有四级最好,2轮面试,至少1轮线下,能长期稳定工作,每个月加班约有30~40小时,正常支付加班费