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Qc validation specialist

Shannon
ARTO
Validation specialist
Posted: 7h ago
Offer description

QC Validation Specialist – Gene Therapy (Onsite, Shannon)We're supporting a growing gene therapy manufacturing site in Shannon with the hire of aQC Validation Specialistto strengthen analytical method validation and transfer into GMP QC laboratories.This is ahands-on, onsite rolesuited to someone who hasdirect experience writing and reviewing validation protocols and reports, particularly forHPLC-based methodsin a regulated environment.Key focus areasAuthoring and reviewing analytical method validation protocols and reportsMethod transfer into GMP QC laboratoriesHPLC method validation (RP-HPLC / SEC)Supporting gene therapy and advanced therapy productsEnsuring compliance with GMP, data integrity, and ICH Q2(R1)What's essentialProven experience designing and writing validation studies (not just executing them)Strong hands-on HPLC experienceBackground in pharma, biologics, or gene therapy QCComfortable working primarily onsite

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