AnestablishedglobalpharmaceuticalorganisationisseekingaQAExecutivetojoinitsQualityteambasedinWatford.ThisroleishighlyQMSandbatch-releasefocused,supportingthereleaseoffinishedpharmaceuticalproductstomarketwhileensuringongoingcompliancewithGxPandregulatorystandards.
Thisisanexcellentopportunityforaqualityprofessionallookingtobuildlong-termexperiencewithinaregulated,internationalpharmaenvironment,workingcloselywithinternalstakeholdersandexternalmanufacturingpartners.
KeyResponsibilities
* Reviewandapprovalofbatchdocumentationtosupporttimelybatchrelease
* EnsurecompliancewithGMP,GDPandcompanyQualityManagementSystems
* ManagementandmaintenanceofQMSdocumentation,includingSOPs,deviations,CAPAsandchangecontrols
* Supportrootcauseinvestigationsandimplementationofcorrectiveandpreventiveactions
* Participateininternalandexternalaudits,includingpreparationandfollow-upactivities
* Supportregulatoryinspectionsandensureinspectionreadiness
* Liaisewithinternaldepartmentsandthird-partymanufacturerstoresolvequalityissues
* SupportcontinuousimprovementinitiativeswithintheQualityfunction
KeyRequirements
1. PreviousexperienceinaQArolewithinthepharmaceuticalindustry
2. StrongworkingknowledgeofGMPandpharmaceuticalQMS
3. Hands-onexperiencewithbatchreviewandbatchrelease
4. Experiencemanagingdeviations,CAPAsandchangecontrols
5. Excel...