1. I provide leadership&managementforqualityactivitiestoensure thatqualityassurance,quality
systems,productperformance testingactivitiesiseffective,efficient&incompliance withregulatory
& qualitystandards. Fundamental qualitysystemprocesstoensure compliance,timeliness&
effectivenesse.g.CAPA,change control,audit,managementreview,suppliercontrol.
Ensure that customercomplaintsare reviewed,withRCCMactivities&escalatedthroughthe
vigilance processwhererequired,includingnotificationof reportable eventstoRA or CA.
Prepare the site & host,external audits(customer/regulatory) ensuringCAPA actionsare
implementedaddressnon-conformances.
Reviewongoingdevelopment of the QMS ensuringimprovedeffectivenessthroughownershipof the
managementreviewprocess.
Ensure that validationsystemisincompliance withrelevantexternal (regulatory) requirementsi.e.
ISO,QSR & IVDD.
Maintainawarenessof newrelevantregulatoryrequirements&alertstaff of requiredsystemand/or
procedural changes.
Lead the qualityteamsensuringpartnershipwiththe Operationsteamsonproductionissues,
training& SOPcompliance,rootcause analysis,CAPA implementation&Qualityrelatedmatters.
Oversee workscheduling,planning,&administrationof the PPlaboratorytoensure targetsare met
withintimeframes.
Ensure PP testingiscarriedoutinaccordance withspecifications&QCrequirements.
Monitor,record,analyse & reporton activities,trends,results&recommendationsrelatingto
productperformance &departmentactivities.
Develop&maintainsystemstomeasure performance againstestablishedstandards.
Provide responsetotechnical enquiries.
Part of the SeniorSite LeadershipTeam. PerformRMand PMS forproduct review.
Write technical specifications,reports,validationdocumentation,SOPs,policies,qualityagreements
& qualitymanual.
Performapproval of batchdocumentation,stabilityreports,plans,investigations,& technical
reports.