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 ROLE Review and approve validation documentation including protocols, reports, risk assessments, and traceability matrices within pre-defined timelines Coordinate the development of validation quality documents ensuring regulatory compliance Document and manage deviations, non-conformances, and corrective actions with proper evaluation Raise and coordinate Change Control Requests (CCRs) for project work, ensuring proper documentation and regulatory impact assessment Ensure regulatory compliance with FDA, EMA,



and company quality standards across all validation activities Proven experience in validation and qualification activities within pharmaceutical or biotechnology industry Hands-on experience in Quality Control operations and laboratory environments Knowledge of QC bench equipment and connectivity systems Solid regulatory knowledge of FDA, EMA guidelines related to validation and qualification Proficiency in preparing validation documentation including protocols, reports, and compliance records Experience with change control processes and deviation management Knowledge of risk assessment methodologies and traceability requirements Experience with connectivity compliance systems in pharmaceutical manufacturing Knowledge of computerized systems validation (CSV) principles Familiarity with calibration management and metrology practices Experience working with external suppliers and contractors REQUIREMENTS: Minimum 2-5 years of industry experience in QC validation and quality systems Strong foundation in pharmaceutical/biotechnology quality control operations QC bench equipment connectivity, validation, and compliance

📌 QC Validation Specialist (Kingston)
🏢 CareerWise Recruitment
📍 Kingston