天津招聘

Key Responsibilities主要岗位职责:
1)Draft and review of validation documents, qualification protocols and reports
起草和审核验证文件、确认草案和报告
2)Understand and comply with the applicable local regulations of Quality, EHS and others, GSK standards for QMS, EHSS etc. and company policy. Adherence to standard operating procedures.
理解并遵守适用的质量、环境、健康及安全等方面的当地法律法规、葛兰素质量管理体系及环境健康安全等方面的标准和公司方针，遵守公司标准操作规程。
3)Update SVMP as per SOPs
按照标准操作规程更新工厂验证主计划（SVMP）
4)Draft and update Validation SOPs as per the GMP and QMS
按照法规和QMS起草和更新验证SOPs
5)Provide guidance / support on validation, in terms of standards, approach and execution;
在验证的标准、方法和执行方面提供指南/支持
6)Facilitate validation Risk assessment and Deviation Investigation
帮助项目团队进行验证过程中的风险评估和偏差调查工作
7)Coach the functional experts to perform validation as per the site validation approach
指导各部门专家参照工厂验证流程进行验证工作
8)Track the validation status as per SVMP
按照工厂验证主计划追踪验证的完成情况
Specialised Knowledge 专业知识:
?文化程度(学历/专业)Education:
大学本科毕业，药学或相关专业毕业
Bachelor degree, major is pharmacy or related
?任职经验Working Experience:
2年以上验证工作经验，具有至少4年制药行业经验
At least two years validation working experience, at least 4 years experience for the pharmaceutical factory.
专业知识/技能
Technical skills:
了解GSK质量组织，以及公司相关制造/包装工艺规程/质量标准，和熟悉相关GQP/GQG/GQMP
Familiar with GSK Quality system, manufacturing procedures and quality standards, familiar with
GQP/GQG/GQMP
了解国家和地方质量政策法规
Familiar with local quality policies熟悉GSK验证系统/报告系统
Familiar with GSK validation system
具有相当的药品生产工艺，验证知识和经验
Have the experience of manufacturing process, validation knowledge
熟悉和掌握验证的生命周期。
Familiar with the validation lifecycle
熟悉和掌握清洁验证和工艺验证
Familiar with the cleaning validation and process validation
熟悉工厂常用的制造设备和实验室的分析设备
Familiar with the manufacturing equipments and analytical equipments
熟悉HVAC, 压缩空气系统和纯水系统等公用设施
Familiar with HVAC, Compress Air and Purified Water etc.
熟悉分析方法的验证
Familiar with the analytical method validation
熟练应用质量管理工具。
Familiar with quality tools.

?计算机及外语水平
Computer and English Level
熟练使用公司应用办公软件
Good office software skill
英语水平较好(流利的读、说、写)，
Good English communication skill( Speak, read and write English smoothly)

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。