天津招聘

Key Responsibilities主要职责:

Key Responsibilities主要职责:


?Be responsible for gathering and reviewing the regulatory changes frequently, organize to perform gap analysis for the regulatory changes, update local procedures accordingly to ensure site procedure and operation are in compliance with latest regulatory requirements, these changes included but not limited to state & provincial rules, regulations, registered product specification, China pharmacopeia (CP), EP, USP etc.
负责定期收集及审核法规变更、组织完成法规变更的差距分析、更新本地规程以确保工厂的规程和操作符合最新的法规要求，这些变更包括但不限于国家级&省级法律、法规、产品注册标准、中国药典、欧洲药典、美国药典等。

?Participate in quality and regulatory affairs related site new product introduction projects, including quality system procedure revision, new supplier profile establishment, registration of new product transfer, manufacture license update to Jiangsu FDA, GMP license application to local FDA, CFDA, new artwork regulatory filling, confirmation of regulatory requirements etc.
参与工厂新产品项目相关的质量和法规事务，包括质量体系规程的更新、新供应商档案的建立、新产品转移的注册事务、江苏省药监局生产许可证的更新、当地药监局、国家药监局的GMP证申请，新图稿的法规备案、法规要求的确认等。

?Participate in applying for or renew site GMP manufacture license, GMP certificates. Be responsible for regulatory dossier preparing, submission and progress tracking. Support regulatory inspection readiness preparation. Communicate with Suzhou FDA/Jiangsu FDA to follow the progress of site regulatory affairs when applicable, track the associated activities post inspection. Maintain and update the procedure for regulatory inspection as appropriate.
参与GMP生产许可证、GMP证书的申请或更新活动。负责法规文档的准备、提交和进程的跟踪。支持法规检查的预备工作。当申请递交后，与苏州药监局/江苏省药监局保持沟通，以跟踪工厂法规事务的进展，以及与检查相关的后续行动。如需要，维护和更新工厂法规检查的程序。

?Maintain site regulatory certificate/ license management system, ensure all regulatory GMP docs are within expiry dates and are retrievable in site.
维护工厂法规证书/许可证管理体系，确保所有GMP文件都在有效期之内并且可追溯查阅。

?Support to apply for or renew drug registration related matters, these registration application / renewal include product registration, Import Drug License, Imported bulk license, and Imported repackaging license etc. Maintain or update site product registration profile after receiving of registered profile from GSK registration function, ensure all regulatory registration docs are within expiry date and are retrievable.
支持药品注册申请或更新相关的事务，这些注册申请/更新包括：产品注册、进口药品注册证，进口半成品注册证，进口分包装许可证等。在收到GSK注册部门的注册文件之后，维护或更新工厂产品注册文件，确保所有的法规注册文件都在有效期之内并且可追溯查阅。

?Act as Supplier Quality Share Service (SQSS) contact, maintain and track site supplier qualification status, update or issue site approved supplier list, regularly review the suppliers’ license to ensure licenses are valid, support regulatory filling for changes of IDL of API and excipient of suppliers and support to re-registration where applicable.
担任SQSS部门的苏州联系人，维护和跟踪工厂供应商的资格状态，更新或发行工厂批准的供应商清单，定期审核供应商许可证以确保许可证的有效性，支持原料药和辅料供应商的药品注册证或进口药品注册证的变更法规备案，以及在需要时支持再注册事务。

?Assist in activities related to site change request including outline change, API/excipient change, artwork change etc., review, submit and follow the regulatory filling associated change control and the related supplementary application.
协助工厂变更要求相关的活动，包括工厂布局变更，原料药和辅料，图稿变更等。审核，提交和跟踪变更控制和补充申请相关的法规备案。

?Be responsible for GSK internal circulation review for new or updated artwork and packaging materials between functions of regulatory registration, medical, commercial team and Suzhou site
负责在注册部、医学部、商业团队和苏州工厂之间对GSK新的或需更新的图稿和包装材料进行内部流转审核

?Prepare for training material, perform site GMP regulatory training and evaluate the effectiveness of the training per site compliance training plan.
准备培训教材、完成工厂GMP法规培训，依据工厂合规培训计划评估法规培训的有效性。

?Carry out other works assigned, participate in programs of GSK global if needed.
完成其他指定的工作，如需要，参加GSK全球项目。

?Follow GSK EHS policy and site EHS procedure.
遵守GSK EHS政策和规程。


Specialized Knowledge专业知识:
?breadth & depth across disciplines or functions; expertise in field required
所需知识的宽度（跨学科），所需知识的深度 （特定学科）

1.Bachelor degree or above, major in Pharmacy or related药学或相关专业大学本科及以上学历
2.Prefer to have experience in pharmaceuticals industry, and have one more year experience of drug regulatory affair or related area.医药行业相关经验，及药品法规事务或相关领域1年以上工作经验
3.The knowledge of cGMP/GSP/GCP. cGMP/GSP/GCP方面的知识
4.Good communication and coordination skill良好的沟通和合作能力
5.Proficient in spoken and written English, good command of office software. 熟练运用口头及书面英语，熟练运用Office 软件。
Desirable:
1.Understanding of CFDA and other international GMP requirements for sterile manufacturing理解中国药监局和其他国家的GMP对于无菌生产的要求
2.Know about the product transfer process including product registration 了解包括产品注册在内的产品转移过程
3.Know about the value stream processes and vision factory.了解药品生产及物流过程及控制
4.Good understanding of documentation management system掌握文件管理系统
5.Know about OE/lean concept了解卓越运作/精益的概念

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。