Senior QC Analyst

PE Global (UK); Cork; On-site; EUR 45,000 - 60,000; Full time

Job summary

PE Global (UK) is seeking a Senior QC Analyst for a contract role based in East Cork. The successful candidate will perform and oversee analytical testing in a GMP-regulated laboratory with a strong focus on HPLC-based methods. Key responsibilities include routine analytical testing, documenting compliance with GMP principles, and supporting laboratory investigations. Ideally, candidates will have over 4 years of experience in a GMP environment and a degree in a relevant field. Interested applicants should send their CV to [e-mail].

Qualifications

• Minimum 4+ years hands-on experience in a GMP laboratory environment.
• Strong practical experience with HPLC instrumentation (e.g. Waters, Agilent, Thermo, Shimadzu).
• Demonstrated experience in routine HPLC testing and stability testing.

Responsibilities

• Perform routine and non-routine analytical testing using HPLC techniques.
• Ensure all work complies with GMP, GDP, and data integrity principles.
• Support laboratory investigations, including OOS and OOT results.

Skills

HPLC techniques

Data integrity awareness

Troubleshooting capabilities

Problem-solving capabilities

Education

Degree in Chemistry, Analytical Science, Pharmaceutical Science

Tools

Chromeleon CDS

Empower

OpenLab

Job description

QAResourceshaveanopportunityforaSrQCAnalystroletobebasedonclientsiteinEastCork:

Contracttoyearend,Shiftrole

RoleOverview

TheSeniorQCAnalystwillberesponsibleforperformingandoverseeinganalyticaltestingwithinaGMP-regulatedlaboratory,withastrongfocusonHPLC-basedmethods.Therolerequiresahighleveloftechnicalexpertise,dataintegrityawareness,andtheabilitytooperateindependentlywhilesupportingcontinuousimprovementandcomplianceinitiatives.

Responsibilities(mayincludebutnotlimitedto):

• Performroutineandnon-routineanalyticaltestingusingHPLCtechniques,including:
• Assayandrelatedsubstances
• Impuritiesprofiling
• Dissolutionandcontentuniformitytesting
• ExecutevalidatedanalyticalmethodsandensureadherencetoGMPrequirements
• Conductstabilityandshelf-lifetestingusingchromatographysystems
• Reviewanalyticaldata,includingchromatograms,integrations,andaudittrails
• Troubleshootchromatographicandinstrumentationissueseffectively
• Supportlaboratoryinvestigations,includingOOS(OutofSpecification)andOOT(OutofTrend)results
• EnsureallworkcomplieswithGMP,GDP,anddataintegrity(ALCOA+)principles
• Maintainaccurateandcompletedocumentationinlinewithregulatoryexpectations
• Participateininternalandexternalaudits/inspectionsasrequired
• Supportequipmentlifecycleactivities,includingIQ/OQ/PQ,calibration,andmaintenance
• Manageworkloadeffectivelyinahigh-throughputQCorstabilityenvironment

Requirements:

• Minimum4+years’hands-onexperienceinaGMPlaboratoryenvironment
• StrongpracticalexperiencewithHPLCinstrumentation(e.g.Waters,Agilent,Thermo,Shimadzu)
• ProvenexperienceusingChromeleonCDS(ThermoFisher)
• ExperiencewithEmpowerorOpenLabisadvantageous
• Demonstratedexperiencein:
• RoutineHPLCtesting
• Stabilitytesting
• Methodexecution
• Datareviewandaudittrailassessment
• Strongtroubleshootingandproblem-solvingcapabilities
• DegreeinChemistry,AnalyticalScience,PharmaceuticalScience,orrelateddiscipline(preferred)

Desirable/Advantageous

• Experiencementoringortrainingjunioranalysts
• Exposuretoequipmentqualification(IQ/OQ/PQ)processes
• Auditandinspectionreadinessexperience

[e-mail]