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Head of quality - rpi

London
Head of quality
£100,000 a year
Posted: 5 August
Offer description

HeadofQuality - RPi Pharmaceuticals Location:CentralLondon|Hybrid/On-Site|Full-Time WearelookingforaQualityAssuranceLeadtooverseecompliance,riskmanagement,andcontinuousimprovementwithinourpharmaceuticaloperations.ThisroleensuresthatallGMP,GDP,andGPvPregulationsaremetwhilemaintainingthehigheststandardsofproductqualityandsafety. KeyResponsibilities Leadership&Compliance LeadanddeveloptheQualityAssuranceteam,fosteringacultureofaccountabilityandexcellence. MaintaincomplianceasaManufacturingAuthorisationHolder(MAH),ensuringadherencetoallGxPstandards. Overseeregulatoryinspections,audits,andqualityriskassessments,ensuringtimelyimplementationofcorrectiveandpreventiveactions(CAPAs). Actastheprimaryliaisonwithregulatoryagenciesandexternalstakeholdersonqualitymatters. QualityManagement&ContinuousImprovement ManageandenhancetheQualityManagementSystem(QMS),includingthemaintenanceofSOPs,documentation,andeQMSimprovements. Implementriskassessmentsandmitigationstrategiesthroughouttheproductlifecycle. Drivecomplianceinitiativesthroughinternaltraining,education,andprocessimprovementprograms. Monitorandreportonqualitymetrics(KPIs),includingdeviationrates,CAPAs,andcustomercomplaints. OperationalOversight EnsureadherencetostandardoperatingproceduresinlinewithGMP,GDP,andGPvPpractices. Manageproductqualitycomplaints,supplierqualifications,andtechnicalagreementswiththird-partyserviceproviders. Supportcross-functionalteams,includingsupplychain,pharmacovigilance,regulatoryaffairs,andmanufacturing,toalignqualityobjectives. Ensurecompliancewithchangecontrols,deviations,non-conformances,andinternalauditobservations. AboutYou StrongknowledgeofGDP,GMP,andGPvPinthepharmaceuticalindustry. Experienceinleadingqualityteamswithaproventrackrecordincomplianceandregulatoryaffairs. EligibleorexperiencedResponsiblePerson(RP)andResponsiblePersonforImport(RPi). FamiliaritywitheQMS,riskmanagement,CAPAs,andsupplieroversight. Stronganalytical,communication,andleadershipskillswiththeabilitytoinfluenceatalllevels. DegreeinLifeSciencesorequivalent. Ifyouarearesults-drivenqualityleaderreadytotakeonahigh-impactroleinafast-paced,compliance-drivenenvironment,wewouldlovetohearfromyou. Applynoworreachoutforaconfidentialdiscussion.

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