工作性质:全职 职位类别:其他
工作职责:
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.Update SVMP as per SOPs
按照标准操作规程更新工厂验证主计划(SVMP)
3.Draft and update Validation SOPs as per the Compliance and QMS
按照法规和QMS起草和更新验证SOPs
4.Provide guidance / support on validation, in terms of standard, approach and execution;
在验证的标准、方法和执行方面提供指南/支持
5.Provide suggestion and requirements on the validation approach in project team
在项目中对于验证方法提供建议和要求以满足GSK和法规要求
6.Risk assessment and Deviation Investigation facilitation in project team
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.Provide input on the project planning in terms of validation
在项目计划的验证方面提供意见
8.Coach the functional experts to perform validation work 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
9.Follow up the validation status as per SVMP
按照工厂验证主计划追踪验证的完成情况
职位要求:
1.大学本科毕业,药学或相关专业毕业
Bachelor degree, major is pharmacy or related
2.2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.
电子邮箱:ch.graduate@gsk.com