职责: Strictly implement the product quality management system and operation rules formulated by the enterprise, and standardize the quality inspection work. 严格执行企业制定的产品质量管理制度和操作规程,规范质量检验工作。
Complete the purchased product inspection and returned product according to the Drug/Device GSP standards, warehousing documents and product ac-ceptance procedures. 按照药品/器械GSP标准、仓储文件和产品验收程序,完成进货检验和退货。
Inspection related documents review and archive.检查相关文件的评审和存档
Acceptance shall be carried out in strict accordance with the prescribed stand-ards, acceptance methods and sampling principles, and shall be completed within the prescribed place and time limit. 严格按照规定的标准、验收方法和抽样原则进行验收,并在规定的地点和期限内完成
COA check and translation for imported product.负责进口产品COA的核对和翻译
Indicate the acceptance conclusion in the system for the inspected goods, make a good record of product quality acceptance, and keep it for future reference in ac-cordance with regulations.对检验货物在系统中注明验收结论,做好产品质量验收记录,并按规定保存备查
The quality changes found in the acceptance shall be timely fed back to the quality management personnel.验收中发现的质量变更,应及时反馈给质量管理人员
Collect quality information, accurately and timely transfer and feedback, and col-lect all kinds of quality收集质量信息,准确、及时地传递和反馈,收集各类质量信息
Information is analyzed, processed, and summarized. Cooperate with the depart-ment to make good quality file. 对各类质量信息进行分析、处理、总结。配合部门做好质量文件的制作
Responsible for the comprehensive inspection and acceptance of the traceable va-rieties of drugs/device purchased and returned by sales.负责对销售购回的可追溯品种的药品/器械进行全面验收
Warehouse quality document management. 仓库质量文件管理
要求: College degree or above in pharmacy, biology, chemistry, medicine or other related area.药学、生物、化学、医学等相关专业学历
Familiar with local GDP (GSP)/GMP.熟悉当地GDP (GSP)/GMP
Above 3 years quality experience in GMP or GDP (GSP) area. 3年以上GMP或GSP领域质量管理经验
Above 1 years quality experience for product inspection and release.1年以上产品检验和放行质量工作经验
Good English skill at reading, writing, listening and speaking.良好的英语听说读写能力
Good communication skills of both scientific and non-scientific information.良好的科学和非科学信息的沟通能力
Professional knowledge in local regulations.熟悉当地法规
Problem solving ability and skills.解决问题的能力和技巧
Ability to face challenge and self-learning.能够面对挑战和自我学习