i.ResponsibleforSOPs/Documentsrelatedactivities;
- Responsibleforpreparation/revision and ReviewofSOP,Protocols,Qualitysystempolicy,Qualitymanualand Guidance documents at CQAfor the harmonization of system / practices/ documentation as a part ofsimplification of procedures or improvement in procedures for different sites ofAlkem and Corporatefunctions.
- ResponsibletoPublish,Issuance/Retrieval/Distributionofdocuments(SOP,Format,Guidancedocumentsand Quality system policy etc.) through eDMS.
iiResponsibleforGlobalCAPAactivities;
- ResponsibletoinitiatetheGlobalCAPAandGlobalCAPAaction.ReviewofGlobalCAPAinitiatedatmanufacturing sites of Alkem and corporate function.
- Review the GAP assessment of GMP trends and US FDA483s observation /internal & external qualityeventsand conductdiscussion withcrossfunctionalteamstoidentifytheGlobalCAPA(s)forevaluationandimplementation across Alkem sites.
- ReviewandmaintenanceofglobalCAPA/CAPAstrackingandVerification.
- ClosureandimplementationofGlobal CAPA.
IiiResponsibleforTrainingActivities
- ResponsibleasCQAtrainingcoordinatorforhandlingofe-TMS(ElectronicTrainingManagementSystem).
- Providetrainingto newjoinee onCQAinductionmodules.
- ResponsibleforreviewofCQAand othercorporatefunction SOPs,Qualitysystempolicyand Guidancedocuments at the time of training.
Iv.ResponsibleforRegulatoryupdatesandGapanalysis
- Tosurfing,selectingofregulatoryupdatesondifferentregulatorysitedasperSOP.
- Responsible forthe preparation of Quarterlyregulatoryupdates and shared toallsited and cross functional v.Responsibleforchangecontrol
