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
PreviousexperienceinaQArolewithinthepharmaceuticalindustry
StrongworkingknowledgeofGMPandpharmaceuticalQMS
Hands-onexperiencewithbatchreviewandbatchrelease
Experiencemanagingdeviations,CAPAsandchangecontrols
Excellentattentiontodetailandstrongdocumentationskills
Confidentcommunicator,abletoworkcross-functionally
Proactivemindsetwiththeabilitytoworkinafast-paced,regulatedenvironment
Desirable
ExperienceworkingwithCMOs/third-partymanufacturers
Exposuretoglobalqualitysystemsormultinationalpharmaenvironments ...