Quality Project Analytical Specialist - Chemistry (Contract)DESCRIPTIONOur client is seeking a QC Analytical (Chemistry) SME (Contract) to provide hands‑on analytical chemistry expertise in support of project delivery, technology transfer, and GMP manufacturing readiness.The QC Analytical SME will primarily support analytical aspects of method transfer, method validation, laboratory readiness, and troubleshooting across project and operational activities. The role will provide direct execution and technical ownership across project phases including commissioning, qualification, and process validation.This is a delivery‑focused contract role, requiring active execution, authorship, and technical problem‑solving within a GMP‑regulated laboratory environment. The role is not intended to be a purely advisory, governance, or people‑management position.Role Purpose / Primary ObjectiveThe QC Analytical (Chemistry) SME will provide hands‑on analytical chemistry expertise in support of manufacturing operations, technology transfer, and project‑driven validation activities at the Cork site.The primary purpose of the role is to execute and technically own QC analytical activities, including analytical method transfer and validation, laboratory instrumentation readiness, and analytical troubleshooting, ensuring robust GMP compliance and project delivery.This is a delivery‑focused contract role, requiring active execution, authorship, and technical problem‑solving rather than purely advisory or oversight responsibilities.Role ContextThe role will primarily support Clariscan / Carraig Mhór project activities, with potential support to other site projects as required. The QC Analytical SME will be embedded within QC and cross‑functional project teams, providing analytical chemistry input across:DesignConstructionQualificationProcess ValidationKey ResponsibilitiesAnalytical Execution & Technical OwnershipProvide hands‑on analytical chemistry support to manufacturing, QC, and project teams.Execute and support:Analytical method transfer and validationAnalytical testing in support of qualification and PV activitiesMethod troubleshooting during tech transfer and routine manufacturingActively troubleshoot analytical method and instrumentation issues as they arise, working closely with Operations, Engineering, and QA through various project phases:Tech transferQualificationProcess validationRoutine manufacturing supportLaboratory Instrumentation & SystemsAct as an analytical SME for QC laboratory instrumentation, including chromatography and elemental analysis techniques (e.g. HPLC, ICP, as applicable).Support sourcing, installation, and qualification of QC laboratory equipment.Ensure analytical instrumentation and systems are compliant with:cGMPData Integrity requirements21 CFR Part 11 expectations as they apply to laboratory systemsSupport laboratory readiness activities for new or modified analytical capabilities.Project & Validation SupportProvide QC Analytical SME input into:Validation strategiesLaboratory and analytical readiness planningAuthor, review, and execute GMP documentation including:Analytical validation protocols and reportsMethod transfer documentationSOPs and technical justificationsSupport validation activities including:IQ / OQ / PQProcess ValidationSupport investigations relating to analytical deviations, OOS/OOT results, and validation discrepancies, ensuring robust root cause analysis and CAPA definition.Quality & ComplianceExecute all analytical activities in compliance with:cGMPData Integrity guidanceSite quality systemsWhat This Role Is / Is NotThis role is:Embedded in project and QC deliveryFocused on doing, authoring, executing, and troubleshootingThis role is not:A people‑management or supervisory roleA strategic or governance‑only chemistry positionQUALIFICATIONS/SKILLS AND EXPERIENCEEducationThird‑level qualification in Chemistry or other relevant science discipline is required.ExperienceMinimum 5 years’ experience in a GMP‑regulated pharmaceutical, biotechnology, or medical diagnostics environment.Demonstrated hands on QC analytical laboratory experience, including:Analytical method validation and/or transferUse of chromatographic and analytical instrumentationPractical working knowledge of:cGMPData Integrity principles21 CFR Part 11 as applied to laboratory systemsExperience supporting project, tech transfer, or validation activities is strongly desirable.Strong analytical chemistry technical problem‑solving capabilityHigh attention to detail and strong GMP documentation disciplineAbility to work independently with minimal supervisionEffective communicator with cross‑functional stakeholdersOrganised, pragmatic, and execution‑focusedPersonal AttributesSelf‑motivated and accountableComfortable with a time‑bound contract roleHands‑on mindset with a strong sense of ownership
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