天津招聘

Key Responsibilities岗位描述:

1.Improve and standardize validation process against GMP, GQP & GQMP, perform gap analysis reports, establish action plan and prepare SOPs.
根据GMP和全球质量政策与管理程序要求优化和规范公司的验证流程，完成差距分析报告完成并制定行动计划，制定相关SOP。
2.Routinely update site master validation plan.
定期更新工厂验证总纲。
3.According to the site master validation plan to coordinate the validation, revalidation, validation review and change control assessment for facility/production equipment/process/computerized system/lab instrument/cleaning process.
根据验证主计划，协调相关各部门的厂房设施、生产设备、工艺、计算机系统、实验室仪器、清洁验证等以及再验证、验证回顾和变更确认。
4.Assist in/lead annual quality improvement projects. Assist in TT & NPI projects and validation/trial practice to ensure quality system in use during these implementations.
协助实施或领导年度质量改进项目。参与技术转移和新产品引入项目以及验证/试机实践，确保质量系统在以上项目的执行中得到体现。
5.Numbering and arching the validation documentation. Timely update and backup the list for validation documents.Keep the documentation orderly without lost and archive timely before handover to documentation administrator.
负责验证文件的统一编码及存档管理。及时更新备份验证文件的清单。文件在递交给文件专员前应保存整齐，不丢失，及时归档。
6.Participate in relevant file preparation, such as annual product review and manufacturing deviation/investigation, analyze the tendency of product quality and raise the proposals to ensure that the product quality will be improved. Familiar with maintenance of Change control management system, participate in coordination to change related projects or activities and change review meetings periodically. Familiar with archiving and sorting of change control documents. CAPA follow up
参与相关文件准备，如年度产品回顾和生产偏差/调查。分析产品质量的趋势，提出建议，确保产品质量提高。熟悉变更控制系统维护，参与协调变更相关计划或活动以及变更审核会议。熟悉变更控制记录的归档和整理。整改措施跟进。
7.Perform self inspection as required and follow up, and ensure the action be taken timely
根据要求进行自检并跟进，确保按时采取措施
8.Participate in handling of customer complaints as appropriate
在需要时参与客户投诉处理。
9.Obey the safe policy of company.
遵守公司的安全政策。
10.Carry out other works arranged by Quality manager
开展质量经理安排的其他工作


Specialised Knowledge 专业知识:
本科以上，制药相关专业优先。
Bachelor degree or above, prefer major in pharmaceutics or related.
2～3年验证相关经验。
2～3 years validation experiences
宜了解相关国家和地方质量政策法规(GMP，GLP等)。
Prefer to know relative state and regional law, such as GMP,GLP.
宜熟悉公司所有相关质量标准/规程，及现行CP和国际通用标准如USP，EP。
Prefer to be familiar with all company quality standard , procedure and CP ,USP,EP.
具有一定的药品生产工艺知识和经验以及质量管理工具应用能力。
Have basic knowledge of medicine production process. Have using capability of quality management tool.
具有质检或相关证书者优先。
Prefer to have quality control or relative certificate.

葛兰素史克制药(苏州)有限公司是由葛兰素史克集团在苏州工业园区独资建造的现代化医药生产基地，该项目注册资金为1亿3千5百万美元，是葛兰素史克集团目前在华投资最大的项目，同时也是目前国内最大规模的外商投资制药企业。