A QC Compliance Specialist is required by CareerWise Recruitment for our Waterford based pharmaceutical company. This is a 23-month contract. This is a hybrid position you can work 3 days on site and 2 days from home. If you have experience in QC bench equipment connectivity, CSV validation and compliance then this is the position for you !!!THE ROLEReview and approve validation documentation including protocols, reports, risk assessments, and traceability matrices within pre-defined timelinesCoordinate the development of validation quality documents ensuring regulatory complianceDocument and manage deviations, non-conformances, and corrective actions with proper evaluationRaise and coordinate Change Control Requests (CCRs) for project work, ensuring proper documentation and regulatory impact assessmentEnsure regulatory compliance with FDA, EMA,
and company quality standards across all validation activitiesProven experience in validation and qualification activities within pharmaceutical or biotechnology industryHands-on experience in Quality Control operations and laboratory environmentsKnowledge of QC bench equipment and connectivity systemsStrong regulatory knowledge of FDA, EMA guidelines related to validation and qualificationProficiency in preparing validation documentation including protocols, reports, and compliance recordsExperience with change control processes and deviation managementKnowledge of risk assessment methodologies and traceability requirementsExperience with connectivity compliance systems in pharmaceutical manufacturing Knowledge of computerized systems validation (CSV) principlesFamiliarity with calibration management and metrology practicesExperience working with external suppliers and contractorsREQUIREMENTS:Minimum 2-5 years of industry experience in QC validation and quality systemsStrong foundation in pharmaceutical/biotechnology quality control operationsQC bench equipment connectivity, validation, and compliance#J-18808-Ljbffr