现场QA(无锡新区)

1.[基础要求Basic Requirement]

教育程度/经验Education background/ Experience

1）大学本科及以上，生物学，药学，化学，生物工程等相关专业。 Bachelor Degree or above degree on biology, pharmacy, chemistry, biological engineering and other related fields.

2）2年以上制药相关工作经验。 Over two years’ experience in Bio-pharmaceutical.

其他要求Other requirements

1) 熟悉GMP生产区域质量管理要求；了解偏差，变更，实验室调查的流程； Familiar with GMP production area quality management requirements; understand the process of deviation, change control and Laboratory investigation;

2) 了解相关区域的中国，FDA，欧盟GMP法规要求； Understand China, FDA, EU GMP regulations requirements in relevant regions;

3) 具备良好的沟通表达能力，基本的英语听说读写能力 Good communication skill and basic listening & speaking & reading & writing in English.

4) 熟练使用计算机办公软件（Word、Excel、PowerPoint）和邮件（Outlook） Use office software (Word, Excel, PowerPoint and Outlook) in proficiency.

2. [工作职责 Job Responsibility]

2.1 负责装配中心的日常以及周期巡检，保证相关的记录、操作及厂房完整性符合GMP及SOP要求； Responsible for daily and routine monitoring of AC to ensure record, operations and facility integrity complied with GMP and SOP requirement;

2.2 能够对质量事件进行初步判断，并提供质量支持与评估； Responsible for providing quality assessment and support for quality events in AC;

2.3 负责装配中心标准操作规程、方案、报告以及组装图纸等文件的审核； Responsible for reviewing SOPs, protocols, reports, assembly drawings from AC;

2.4负责组装批次的给号和组装记录的审核，负责放行任务的追踪以及放行文件的出具； Responsible for issuing and reviewing of AC batch assembly record, responsible for the tracking the release request and issuing of release document;

2.5 负责调拨和PWSM物料的放行文件确认； Responsible for the release document confirmation of allocated and PWSM materials;

2.6完成上级领导安排的其他工作。 Other tasks assigned by supervisor.