工作性質(zhì):全職 職位類別:其他
工作職責(zé):
1.Draft and review of validation documents, qualification protocols and reports
起草和審核驗證文件、確認(rèn)草案和報告
2.Update SVMP as per SOPs
按照標(biāo)準(zhǔn)操作規(guī)程更新工廠驗證主計劃(SVMP)
3.Draft and update Validation SOPs as per the Compliance and QMS
按照法規(guī)和QMS起草和更新驗證SOPs
4.Provide guidance / support on validation, in terms of standard, approach and execution;
在驗證的標(biāo)準(zhǔn)、方法和執(zhí)行方面提供指南/支持
5.Provide suggestion and requirements on the validation approach in project team
在項目中對于驗證方法提供建議和要求以滿足GSK和法規(guī)要求
6.Risk assessment and Deviation Investigation facilitation in project team
幫助項目團(tuán)隊進(jìn)行驗證過程中的風(fēng)險評估和偏差調(diào)查工作
7.Provide input on the project planning in terms of validation
在項目計劃的驗證方面提供意見
8.Coach the functional experts to perform validation work as per the site validation approach
指導(dǎo)各部門專家參照工廠驗證流程進(jìn)行驗證工作
9.Follow up the validation status as per SVMP
按照工廠驗證主計劃追蹤驗證的完成情況
職位要求:
1.大學(xué)本科畢業(yè),藥學(xué)或相關(guān)專業(yè)畢業(yè)
Bachelor degree, major is pharmacy or related
2.2年以上驗證工作經(jīng)驗,具有至少4年制藥行業(yè)經(jīng)驗
At least two years validation working experience, at least 4 years experience for the pharmaceutical factory.
電子郵箱:ch.graduate@gsk.com